Badanie oceniające rokatynlimab w skojarzeniu z miejscowymi kortykosteroidami i/lub miejscowymi inhibitorami kalcyneuryny u dorosłych uczestników z umiarkowanym do ciężkiego atopowym zapaleniem skóry (AZS) (ROCKET-SHUTTLE)
4 sierpnia 2026 zaktualizowane przez: Amgen
Randomizowane, 24-tygodniowe, kontrolowane placebo badanie fazy 3 z podwójnie ślepą próbą oceniające skuteczność, bezpieczeństwo i tolerancję rokatynlimabu (AMG 451) w skojarzeniu z miejscowymi kortykosteroidami i/lub miejscowymi inhibitorami kalcyneuryny u dorosłych pacjentów z umiarkowaną do ciężkiego atopowego zapalenia skóry (AZS) (ROCKET-SHUTTLE)
Równorzędnymi celami badania są:
- Ocena skuteczności rokatynlimabu w skojarzeniu z miejscowym kortykosteroidem i/lub miejscowym inhibitorem kalcyneuryny (TCS/TCI) w porównaniu z placebo w skojarzeniu z TCS/TCI w 24. tygodniu, oceniana za pomocą globalnej oceny atopowego zapalenia skóry zatwierdzonego badacza (vIGA-AD) .
- Ocena skuteczności rokatynlimabu w skojarzeniu z TCS/TCI w porównaniu z placebo w skojarzeniu z TCS/TCI w 24. tygodniu, oceniana za pomocą wskaźnika obszaru i nasilenia wyprysku (EASI).
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
746
Faza
- Faza 3
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Buenos Aires
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CABA, Buenos Aires, Argentyna, C1027AAP
- CINME - Centro De Investigaciones Metabolicas
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La Plata, Buenos Aires, Argentyna, B1902COS
- Framingham Centro Médico
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Ramos Mejía, Buenos Aires, Argentyna, 1704
- DIM Clinica Privada
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Distrito Federal
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Buenos Aires, Distrito Federal, Argentyna, 1121
- Fundacion CIDEA
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Buenos Aires, Distrito Federal, Argentyna, 1054
- Buenos Aires Skin SA
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Buenos Aires, Distrito Federal, Argentyna, 1414
- Care- Centro de Alergia y Enfermedades Respiratorias
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Buenos Aires, Distrito Federal, Argentyna, 1425
- Psoriahue Medicina Interdisciplinaria SRL
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Santa Fe Province
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Rosario, Santa Fe Province, Argentyna, 2000
- Centro de Investigaciones Clinicas Instituto Especialidades De La Salud De Rosario
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New South Wales
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Botany, New South Wales, Australia, 2019
- Emeritus Research Sydney
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Westmead, New South Wales, Australia, 2145
- Westmead Hospital
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Queensland
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Benowa, Queensland, Australia, 4217
- The Skin Centre
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South Brisbane, Queensland, Australia, 4101
- Princess Alexandra Hospital
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Woolloongabba, Queensland, Australia, 4102
- Veracity Clinical Research
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Victoria
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Camberwell, Victoria, Australia, 3124
- Emeritus Research Melbourne
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Graz, Austria, 8036
- Medizinische Universitaet Graz
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Innsbruck, Austria, 6020
- Medizinische Universitaet Innsbruck
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Salzburg, Austria, 5020
- Landeskrankenhaus Salzburg
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Vienna, Austria, 1030
- Klinik Landstraße
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Vienna, Austria, 1130
- Klinik Hietzing
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Bruges, Belgia, 8000
- Algemeen Ziekenhuis Sint-Jan Brugge-Oostende
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Brussels, Belgia, 1090
- Universitair Ziekenhuis Brussel
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Brussels, Belgia, 1020
- Centre Hospitalier Universitaire Brugmann
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Brussels, Belgia, 1200
- Universite Catholique de Louvain Cliniques Universitaires Saint Luc
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Ghent, Belgia, 9000
- Universitair Ziekenhuis Gent
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Herstal, Belgia, 4040
- Clinique Andre Renard
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Kortrijk, Belgia, 8500
- Dermatologie Handelskaai
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Leuven, Belgia, 3000
- Universitaire Ziekenhuizen Leuven Gasthuisberg
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Liège, Belgia, 4000
- Centre Hospitalier Universitaire de Liege - Sart Tilman
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Loverval, Belgia, 6280
- Grand Hopital de Charleroi
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Dupnitsa, Bułgaria, 2600
- Medical Center Asklepii OOD
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Pleven, Bułgaria, 5800
- Medical center Medconsult Pleven OOD
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Sofia, Bułgaria, 1407
- Medical Center Excelsior OOD
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Sofia, Bułgaria, 1431
- Diagnostic-Consultative Center Alexandrovska EOOD
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Sofia, Bułgaria, 1463
- Diagnostic-Consultative Center - Fokus-5 - Medical Institution for Outpatient Care OOD
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Beijing, Chiny, 100044
- Peking University Peoples Hospital
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Shanghai, Chiny, 200443
- Shanghai Skin Disease Hospital
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Beijing Municipality
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Beijing, Beijing Municipality, Chiny, 100191
- Peking University Third Hospital
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Beijing, Beijing Municipality, Chiny, 100050
- Beijing Friendship Hospital, Capital Medical University
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Fujian
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Fuzhou, Fujian, Chiny, 350000
- The First Affiliated Hospital of Fujian Medical University
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Guangdong
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Guangzhou, Guangdong, Chiny, 510091
- Dermatology Hospital of Southern Medical University
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Guangzhou, Guangdong, Chiny, 510120
- Sun Yat-sen Memorial Hospital Sun Yat-sen university
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Guangzhou, Guangdong, Chiny, 510080
- The First Affiliated Hospital ,Sun-Yat Sen University
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Shantou, Guangdong, Chiny, 515041
- The Fist Affiliated Hospital of Shantou University Medical College
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Shenzhen, Guangdong, Chiny, 518101
- Shenzhen Qianhai Shekou Free Trade Zone Hospital
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Henan
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Nanyang, Henan, Chiny, 473002
- Nanyang First Peoples Hospital
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Hubei
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Wuhan, Hubei, Chiny, 430022
- Union Hospital Tongji Medical College Huazhong University of Science and Technology
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Jiangsu
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Wuxi, Jiangsu, Chiny, 214001
- Wuxi Second Peoples Hospital
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Jiangxi
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Nanchang, Jiangxi, Chiny, 330000
- Dermatology Hospital of Jiangxi Province
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Jilin
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Changchun, Jilin, Chiny, 130021
- The First Hospital of Jilin University
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Sichuan
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Chengdu, Sichuan, Chiny, 610017
- Chengdu Second Peoples Hospital
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Zhejiang
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Hangzhou, Zhejiang, Chiny, 310003
- the First Affiliated Hospital Zhejiang University School of Medicine
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Hangzhou, Zhejiang, Chiny, 310016
- Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
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Hangzhou, Zhejiang, Chiny, 310020
- Affiliated Hangzhou First Peoples Hospital，Zhejiang University School of Medicine
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Ningbo, Zhejiang, Chiny, 315010
- The First Affiliation Hospital Of Ningbo University
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Taizhou, Zhejiang, Chiny, 318000
- Taizhou Central Hospital
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Antony, Francja, 92160
- Hopital Prive d Antony
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Bordeaux, Francja, Cedex
- Centre Hospitalier Universitaire de Bordeaux - Hopital Saint Andre
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Brest, Francja, 29200
- Centre Hospitalier Regional Universitaire Brest Hopital Morvan
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Lille, Francja, 59037
- Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez
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Lorient, Francja, 56322
- Centre Hospitalier de Bretagne Sud - Hopital du Scorff
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Marseille, Francja, 13385
- Hôpital La Timone
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Martigues, Francja, 13500
- Cabinet du Docteur Ruer-Mulard Mireille
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Nantes, Francja, 44093
- Centre Hospitalier Universitaire de Nantes Hôtel Dieu
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Nice, Francja, 06202
- Centre Hospitalier Universitaire Archet 2
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Paris, Francja, 75020
- Hôpital Tenon
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Paris, Francja, 75475
- Hôpital Saint Louis
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Paris, Francja, 75018
- Hopital Bichat Claude Bernard
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Reims, Francja, 51100
- Polyclinique de Courlancy
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Rennes, Francja, 35033
- Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
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Rouen, Francja, 76031
- Centre Hospitalier Universitaire de Rouen - Hopital Charles Nicolle
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Saint-Priest-en-Jarez, Francja, 42270
- Centre Hospitalier Universitaire Saint Etienne Hopital Nord
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Toulon, Francja, 83800
- Hopital d instruction des armees sainte anne
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Athens, Grecja, 11525
- 401 General Military Hospital Of Athens
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Athens, Grecja, 16121
- Andreas Syngros Hospital Of Venereal And Dermatological Diseases
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Heraklion, Grecja, 71500
- University General Hospital of Heraklion
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Nea Ionia, Grecja, 14233
- General Hospital Of Nea Ionia Konstantopouleio Patision
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Piraeus, Grecja, 18536
- Geniko Nosokomeio Peiraia Tzaneio
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Thessaloniki, Grecja, 54642
- Ippokratio General Hospital of Thessaloniki
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Madrid, Hiszpania, 28041
- Hospital Universitario 12 de Octubre
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Pontevedra, Hiszpania, 36001
- Complexo Hospitalario Universitario de Pontevedra
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Basque Country
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Bilbao, Basque Country, Hiszpania, 48013
- Hospital Universitario Basurto
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Catalonia
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Barcelona, Catalonia, Hiszpania, 08036
- Hospital Clinic i Provincial de Barcelona
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Valencia
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Valencia, Valencia, Hiszpania, 46014
- Hospital General Universitario de Valencia
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Bergen op Zoom, Holandia, 4624 VT
- Bravis Ziekenhuis
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Groningen, Holandia, 9700 RB
- Universitair Medisch Centrum Groningen
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Utrecht, Holandia, 3584 CX
- Universitair Medisch Centrum Utrecht
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Aichi-ken
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Nagoya, Aichi-ken, Japonia, 454-0803
- Fukui Dermatology Clinic
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Fukuoka
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Fukuoka, Fukuoka, Japonia, 812-0013
- Ekihigashi Dermatology Allergy Clinic
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Hokkaido
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Obihiro-shi, Hokkaido, Japonia, 080-0013
- Takagi Dermatological Clinic Branch
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Sapporo, Hokkaido, Japonia, 060-0063
- Medical Corporation Kojinkai Sapporo Skin Clinic
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Kagoshima-ken
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Kagoshima, Kagoshima-ken, Japonia, 890-0063
- Katahira Dermatology Urology Clinic
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Kanagawa
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Kawasaki-shi, Kanagawa, Japonia, 211-0063
- Kosugi Dermatology Clinic
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Yokohama, Kanagawa, Japonia, 221-0825
- Nomura Dermatology Clinic
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Kumamoto
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Kumamoto, Kumamoto, Japonia, 860-0066
- Jouzan Hihuka Hinyoukika Clinic
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Kumamoto, Kumamoto, Japonia, 862-0950
- Suizenji Dermatology Clinic
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Osaka
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Neyagawa, Osaka, Japonia, 572-0838
- Yoshioka Dermatology Clinic
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Shizuoka
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Hamamatsu, Shizuoka, Japonia, 430-0929
- JA Shizuoka Kohseiren Enshu Hospital
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Tokyo
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Adachi-ku, Tokyo, Japonia, 120-0034
- Mildix Skin Clinic
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Setagaya-ku, Tokyo, Japonia, 158-0097
- Naoko Dermatology Clinic
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Shinagawa-ku, Tokyo, Japonia, 141-8625
- Ntt Medical Center Tokyo
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Shinjuku-ku, Tokyo, Japonia, 169-0075
- Yamate Dermatology Clinic
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Alberta
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Calgary, Alberta, Kanada, T2J 7E1
- Dermatology Research Institute Incorporated
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Edmonton, Alberta, Kanada, T5J 3S9
- Laser Rejuvenation Clinics Edmonton D T Incorporated
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Edmonton, Alberta, Kanada, T6G 1C3
- Alberta Derma Surgery Centre
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British Columbia
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Surrey, British Columbia, Kanada, V3V 0C6
- Enverus Medical Research
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Manitoba
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Winnipeg, Manitoba, Kanada, R3M 3Z4
- Wiseman Dermatology Research Incorporated
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Ontario
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Coburg, Ontario, Kanada, K9A 4J9
- Skin Health
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London, Ontario, Kanada, N6A 2C2
- Centricity Research London
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Newmarket, Ontario, Kanada, L3Y 5G8
- Dr SK Siddha Medicine Professional Corporation
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Niagara Falls, Ontario, Kanada, L2H 1H5
- Allergy Research Canada Incorporated
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North Bay, Ontario, Kanada, P1B 3Z7
- North Bay Dermatology Centre
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Ottawa, Ontario, Kanada, K2C 3N2
- Dermatology Ottawa Research Centre
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Ottawa, Ontario, Kanada, K2C 3N2
- JRB Research Incorporated
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Richmond Hill, Ontario, Kanada, L4B 1A5
- The Centre for Dermatology
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Toronto, Ontario, Kanada, M2N 3A6
- North York Research Incorporated
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Toronto, Ontario, Kanada, M3H 5Y8
- Toronto Research Centre Inc
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Waterloo, Ontario, Kanada, N2J 1C4
- Alliance Clinical Trials
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Quebec
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Montreal, Quebec, Kanada, H2X 2V1
- Innovaderm Research Inc
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Montreal, Quebec, Kanada, H1Y 3L1
- Clinique de Dermatologie Rosemont
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Québec, Quebec, Kanada, G1W 4R4
- Centre de Recherche Saint-Louis
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Québec, Quebec, Kanada, G1V 4T3
- Diex Recherche Quebec
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Saskatchewan
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Saskatoon, Saskatchewan, Kanada, S7T 0G3
- Saskatoon Dermatology Centre
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Johor
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Johor Bahru, Johor, Malezja, 81100
- Hospital Sultan Ismail
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Kuala Lumpur
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Kuala Lumpur, Kuala Lumpur, Malezja, 50586
- Hospital Kuala Lumpur
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Kuala Lumpur, Kuala Lumpur, Malezja, 59100
- University Malaya Medical Centre
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Kuala Lumpur, Kuala Lumpur, Malezja, 56000
- Pusat Perubatan Universiti Kebangsaan Malaysia
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Perak
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Ipoh, Perak, Malezja, 30450
- Hospital Raja Permaisuri Bainun
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Pulau Pinang
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George Town, Pulau Pinang, Malezja, 10990
- Hospital Pulau Pinang
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Sabah
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Kota Kinabalu, Sabah, Malezja, 88586
- Queen Elizabeth Hospital
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Frankfurt am Main, Niemcy, 60590
- Universitaetsklinikum Frankfurt
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Göttingen, Niemcy, 37075
- Universitaetsmedizin Goettingen - Georg-August-Universitaet
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Hamburg, Niemcy, 22391
- MensingDerma Research GmbH
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Hamburg, Niemcy, 20537
- TFS Trial Form Support GmbH
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Hanover, Niemcy, 30625
- Medizinische Hochschule Hannover
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Hanover, Niemcy, 30159
- Hautaerzte Zentrum Hannover
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Mainz, Niemcy, 55101
- Universitaetsmedizin Mainz
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Memmingen, Niemcy, 87700
- Beldio Research Gmbh
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Merzing, Niemcy, 66663
- Hautmedizin Saar
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München, Niemcy, 80802
- Klinikum rechts der Isar der TUM
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Chorzów, Polska, 41-500
- Dermapolis Medical Dermatology Center dr n med Edyta Gebska
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Katowice, Polska, 40-600
- GynCentrum Spzoo NZOZ Holsamed - Oddzial Libero
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Krakow, Polska, 30-002
- Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy Marek Brzewski Pawel Brzewski SpCywilna
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Lodz, Polska, 90-349
- AppleTreeClinics Network Spzoo
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Lodz, Polska, 90-752
- Ip Clinic Sp zoo
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Szczecin, Polska, 71-500
- Twoja Przychodnia SCM
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Wroclaw, Polska, 51-503
- DermMedica Spzoo Centrum Columbus
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Caguas, Portoryko, 00727-9507
- Doctor Samuel Sanchez PSC
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Brasov, Rumunia, 500112
- Theramed Healthcare SRL
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Cluj-Napoca, Rumunia, 400431
- Institutul Regional de Gastroenterologie si Hepatologie Prof Dr Octavian Fodor
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Târgu Mureş, Rumunia, 540613
- Spitalul Clinic Judetean Mures
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Singapore, Singapur, 308205
- National Skin Centre
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Singapore, Singapur, 168753
- Singapore General Hospital
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Singapore, Singapur, 117599
- National University Hospital
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Alabama
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Birmingham, Alabama, Stany Zjednoczone, 35233
- The University of Alabama at Birmingham
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Arizona
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Phoenix, Arizona, Stany Zjednoczone, 85006
- Medical Dermatology Specialists
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Phoenix, Arizona, Stany Zjednoczone, 85018
- Southwest Skin Specialists
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Sun City West, Arizona, Stany Zjednoczone, 85375
- US Dermatology Partners Sun City West
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Arkansas
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North Little Rock, Arkansas, Stany Zjednoczone, 72117
- Arkansas Research Trials, LLC
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California
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Bakersfield, California, Stany Zjednoczone, 93301
- Kern Research Inc
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Los Angeles, California, Stany Zjednoczone, 90056
- Wallace Medical Group Inc
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Los Angeles, California, Stany Zjednoczone, 90033
- Keck Medicine of University of Southern California
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Palmdale, California, Stany Zjednoczone, 93551
- Antelope Valley Clinical Trials
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Sacramento, California, Stany Zjednoczone, 95816
- University of California at Davis Medical Center
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Sacramento, California, Stany Zjednoczone, 95823
- Kaiser Permanente South Sacramento Medical Center
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San Diego, California, Stany Zjednoczone, 92120
- Acclaim Clinical Research
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San Francisco, California, Stany Zjednoczone, 94132
- Synergy Dermatology
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San Francisco, California, Stany Zjednoczone, 94118
- Kaiser Permanente Medical Center - Oakland
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San Francisco, California, Stany Zjednoczone, 94118
- Kaiser Permanente Medical Center - San Francisco
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Florida
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Tampa, Florida, Stany Zjednoczone, 33609
- TrueBlue Clinical Research
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Tampa, Florida, Stany Zjednoczone, 33615
- Olympian Clinical Research - Tampa
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Georgia
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Alpharetta, Georgia, Stany Zjednoczone, 30022
- Atlanta Dermatology, Vein and Research Center, PC
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Atlanta, Georgia, Stany Zjednoczone, 30315
- Divine Dermatology and Aesthetics
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Illinois
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Skokie, Illinois, Stany Zjednoczone, 60077
- Northshore University Healthsystem
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Indiana
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Clarksville, Indiana, Stany Zjednoczone, 47129
- DS Research
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Indianapolis, Indiana, Stany Zjednoczone, 46250
- Dawes Fretzin Clinical Research Group, LLC
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Kansas
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Leawood, Kansas, Stany Zjednoczone, 66211
- Dermatology and Skin Cancer Center Leawood
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Louisiana
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Monroe, Louisiana, Stany Zjednoczone, 71201
- Industrial Medicine Associates Clinical Research Advanced Dermatology Care
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Maryland
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Rockville, Maryland, Stany Zjednoczone, 20850
- Aesthetic and Dermatology Center
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Michigan
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Ann Arbor, Michigan, Stany Zjednoczone, 48109
- University of Michigan Medical Center
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Auburn Hills, Michigan, Stany Zjednoczone, 48326
- Oakland Hills Dermatology
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Nebraska
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Lincoln, Nebraska, Stany Zjednoczone, 68505
- Somnos Clinical Research
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Omaha, Nebraska, Stany Zjednoczone, 68144
- Skin Specialists PC
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Nevada
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Las Vegas, Nevada, Stany Zjednoczone, 89119
- Vivida Dermatology
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North Las Vegas, Nevada, Stany Zjednoczone, 89030
- Las Vegas Clinical Trials
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New Jersey
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Hackensack, New Jersey, Stany Zjednoczone, 07601
- Schweiger Dermatology Group, PC Research Division
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New Mexico
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Albuquerque, New Mexico, Stany Zjednoczone, 87102
- Albuquerque Clinical Trials Incorporated
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New York
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The Bronx, New York, Stany Zjednoczone, 10455
- CHEAR Center LLC
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North Carolina
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Wilmington, North Carolina, Stany Zjednoczone, 28401
- Accellacare of Wilmington
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Ohio
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Bexley, Ohio, Stany Zjednoczone, 43209
- Bexley Dermatology Research
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Oregon
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Medford, Oregon, Stany Zjednoczone, 97504
- Velocity Clinical Research Inc
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Pennsylvania
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Philadelphia, Pennsylvania, Stany Zjednoczone, 19103
- Paddington Testing Company Inc
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Pittsburgh, Pennsylvania, Stany Zjednoczone, 15213
- University of Pittsburgh Medical Center
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South Dakota
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Rapid City, South Dakota, Stany Zjednoczone, 57702
- Health Concepts
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Texas
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Austin, Texas, Stany Zjednoczone, 78759
- US Dermatology Partners Jollyville
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El Paso, Texas, Stany Zjednoczone, 79925
- Newco 3A Research LLC
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Kerrville, Texas, Stany Zjednoczone, 78028
- Sante Clinical Research
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Plano, Texas, Stany Zjednoczone, 75025
- Texas Dermatology Research Center
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Virginia
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Norfolk, Virginia, Stany Zjednoczone, 23502
- Virginia Dermatology and Skin Cancer Center
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Bern, Szwajcaria, 3010
- Inselspital Bern
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Geneva, Szwajcaria, 1211
- Hôpitaux Universitaires de Genève
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Lausanne, Szwajcaria, 1011
- Centre Hospitalier Universitaire Vaudois
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Sankt Gallen, Szwajcaria, 9007
- Kantonsspital Sankt Gallen
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Zurich, Szwajcaria, 8091
- Universitaetsspital Zuerich
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-
-
-
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Bardejov, Słowacja, 085 01
- Maxderm, sro
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Bratislava, Słowacja, 813 69
- Univerzitna nemocnica Bratislava - Nemocnica Stare Mesto
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Prešov, Słowacja, 081 81
- Fakultna nemocnica s poliklinikou JA Reimana Presov
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Svidník, Słowacja, 089 01
- Sanare spol sro
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-
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Ljubljana, Słowenia, 1000
- Univerzitetni klinicni center Ljubljana
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Maribor, Słowenia, 2000
- Univerzitetni Klinicni Center Maribor
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-
-
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Ankara, Turcja (Türkiye), 06800
- Ankara Bilkent Sehir Hastanesi
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Istanbul, Turcja (Türkiye), 34390
- Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
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Istanbul, Turcja (Türkiye), 34662
- Acibadem Altunizade Hastanesi
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Istanbul, Turcja (Türkiye), 34899
- Marmara Universitesi Tip Fakultesi Hastanesi
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Samsun, Turcja (Türkiye), 55200
- Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
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-
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Budapest, Węgry, 1036
- Obudai Egeszsegugyi Centrum Kft
-
Budapest, Węgry, 1027
- Csalogany Orvosi Kozpont
-
Budapest, Węgry, 1033
- Clinexpert Kft
-
Békéscsaba, Węgry, 5600
- Trial Pharma Kft
-
Debrecen, Węgry, 4032
- Debreceni Egyetem Klinikai Kozpont
-
Gyöngyös, Węgry, 3200
- Gyongyosi Bugat Pal Korhaz
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Kaposvár, Węgry, 7400
- Somogy Varmegyei Kaposi Mor Oktato Korhaz
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Orosháza, Węgry, 5900
- DermaMed Research Kft
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Szolnok, Węgry, 5000
- Allergo-Derm Bakos Kft
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Zalaegerszeg, Węgry, 8900
- Obudai Egeszsegugyi Centrum Kft
-
-
-
-
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Genova, Włochy, 16132
- Ospedale Policlinico San Martino IRCCS
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LAquila, Włochy, 67100
- Ospedale San Salvatore
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Roma, Włochy, 00168
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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Rozzano MI, Włochy, 20089
- Irccs Istituto Clinico Humanitas
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-
-
-
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Bath, Zjednoczone Królestwo, BA1 3NG
- Royal United Hospitals Bath NHS Foundation Trust
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Dudley, Zjednoczone Królestwo, DY1 2HQ
- Russells Hall Hospital
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Isleworth, Zjednoczone Królestwo, TW7 6AF
- West Middlesex University Hospital
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London, Zjednoczone Królestwo, NW3 2PF
- The Royal Free Hospital
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Salford, Zjednoczone Królestwo, M6 8HD
- Salford Care Organisation
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Shipley, Zjednoczone Królestwo, BD18 3SA
- Accellacare Yorkshire
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat do 100 lat (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Opis
Kryteria przyjęcia:
- Wiek ≥ 18 lat z rozpoznaniem AZS według AAD (American Academy of Dermatology) Consensus Criteria (2014) obecne od co najmniej 6 miesięcy
- Historia niewystarczającej odpowiedzi na TCS o średniej lub większej mocy w ciągu 6 miesięcy (z lub bez TCI)
- Wynik EASI ≥16
- Wynik VIGA-AD ≥3
- ≥10% powierzchni ciała (BSA) zajęcia AD
- Numeryczna skala oceny najgorszego świądu ≥ 4
Kryteria wyłączenia:
- Leczenie produktem biologicznym w ciągu 12 tygodni lub 5 okresów półtrwania, w zależności od tego, który okres jest dłuższy, przed 1. dniem
Leczenie dowolnym z poniższych leków lub terapii w ciągu 4 tygodni lub 5 okresów półtrwania, w zależności od tego, który z tych okresów jest dłuższy, przed 1. dniem:
- Ogólnoustrojowe kortykosteroidy
- Ogólnoustrojowe leki immunosupresyjne
- Światłolecznictwo
- Inhibitory kinazy janusowej
Leczenie dowolnym z poniższych leków lub terapii w ciągu 1 tygodnia przed dniem 1:
- TCS
- TCI
- Środki przeciwświądowe
- Miejscowe inhibitory fosfodiesterazy typu 4
- Inne miejscowe środki immunosupresyjne
- Złożone środki miejscowe, w tym TCS o dowolnej mocy lub TCI, inhibitory PDE4 lub inne miejscowe środki immunosupresyjne
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Zadanie sekwencyjne
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Rocatinlimab Dawka 1 + TCS/TCI
Rocatinlimab Dawka 1 co 4 tygodnie (Q4W) przez 24 tygodnie + TCS/TCI + dawka nasycająca w 2. tygodniu.
|
Wstrzyknięcie podskórne (SC).
Inne nazwy:
|
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Eksperymentalny: Rocatinlimab Dawka 2 + TCS/TCI
Rocatinlimab Dawka 2 co 4 tyg. przez 24 tygodnie + TCS/TCI + dawka nasycająca w 2. tygodniu.
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Wstrzyknięcie podskórne (SC).
Inne nazwy:
|
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Komparator placebo: Placebo + TCS/TCI
Placebo Q4W przez 24 tygodnie + TCS/TCI + dawka nasycająca w 2. tygodniu.
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Wstrzyknięcie SC
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Number of Participants Who Achieved ≥ 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75) at Week 24
Ramy czasowe: Baseline and Week 24
|
EASI was designed and widely used to assess the severity and extent of AD across four anatomical regions.
It evaluated key signs of inflammation, including erythema, induration/papulation, excoriation, and lichenification.
The total EASI score ranged from 0 to 72, with higher scores indicating more severe disease.
EASI 75 was defined as a ≥ 75% reduction from baseline in the total EASI score.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 24
|
|
Number of Participants Who Achieved Validated Investigator's Global Assessment for AD (vIGA-AD) 1 Response With Presence of Only Barely Perceptible Erythema or vIGA-AD 0 Response (Revised Investigator's Global Assessment [rIGA] 0/1) at Week 24
Ramy czasowe: Baseline and Week 24
|
vIGA-AD was a validated instrument rating AD severity on a 5-point scale (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe), with higher scores indicating greater severity.
Participants achieving a score of 0 or 1 with ≥2-point reduction from baseline were considered 'Clear' or 'Almost clear'.
For rIGA 0/1, when vIGA-AD = 1, investigators answered: "Did participant have barely perceptible erythema, no induration/papulation, no lichenification, and no oozing/crusting?"
If "Yes," participant met rIGA 0/1; if "No," they did not.
If vIGA-AD = 0, participant met rIGA 0/1.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 24
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Number of Participants Who Achieved EASI 75 at Week 16
Ramy czasowe: Baseline and Week 16
|
EASI was designed and widely used to assess the severity and extent of AD across four anatomical regions.
It evaluated key signs of inflammation, including erythema, induration/papulation, excoriation, and lichenification.
The total EASI score ranged from 0 to 72, with higher scores indicating more severe disease.
EASI 75 was defined as a ≥ 75% reduction from baseline in the total EASI score.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 16
|
|
Number of Participants Who Achieved a vIGA-AD Score of 0 (Clear) or 1 (Almost Clear) (vIGA-AD 0/1) at Week 16
Ramy czasowe: Baseline and Week 16
|
The vIGA-AD was a validated assessment instrument used in clinical studies to globally rate the severity of AD on a 5-point scale ranging from 0 to 4, where 0 = Clear, 1 = Almost clear, 2 = Mild, 3 = Moderate, and 4 = Severe.
Higher scores indicated greater disease severity.
Participants who achieved a score of 0 or 1 with a ≥ 2-point reduction from baseline were considered to have achieved 'Clear' or 'Almost clear' status.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 16
|
|
Number of Participants Who Achieved a ≥ 4-point Reduction From Baseline in Weekly Average of Daily Worst Pruritus Numeric Rating Scale (NRS) Score at Week 16 in Participants With Baseline Weekly Average of Daily Worst Pruritus NRS Score ≥ 4
Ramy czasowe: Baseline and Week 16
|
The Worst Pruritus was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of itch.
Participants were asked to rate the intensity of their worst itch using this scale.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 16
|
|
Number of Participants Who Achieved a ≥ 4-point Reduction From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24 in Participants With Baseline Weekly Average of Daily Worst Pruritus NRS Score ≥ 4
Ramy czasowe: Baseline and Week 24
|
The Worst Pruritus was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of itch.
Participants were asked to rate the intensity of their worst itch using this scale.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 24
|
|
Number of Participants Who Achieved ≥ 90% Reduction From Baseline in EASI Score (EASI 90) at Week 24
Ramy czasowe: Baseline and Week 24
|
The EASI was designed and widely used to assess the severity and extent of AD across four anatomical regions.
It evaluated key signs of inflammation, including erythema, induration/papulation, excoriation, and lichenification.
The total EASI score ranged from 0 to 72, with higher scores indicating more severe disease.
EASI 90 was defined as a ≥ 90% improvement from baseline in the total EASI score.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 24
|
|
Number of Participants Who Achieved a vIGA-AD Score of 0 (Clear) or 1 (Almost Clear) With a ≥ 2-Point Reduction From Baseline (vIGA-AD 0/1) at Week 24
Ramy czasowe: Baseline and Week 24
|
The vIGA-AD was a validated assessment instrument used in clinical studies to globally rate the severity of AD on a 5-point scale ranging from 0 to 4, where 0 = Clear, 1 = Almost clear, 2 = Mild, 3 = Moderate, and 4 = Severe.
Higher scores indicated greater disease severity.
Participants who achieved a score of 0 or 1 with a ≥ 2-point reduction from baseline were considered to have achieved 'Clear' or 'Almost clear' status.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 24
|
|
Number of Participants Who Achieved Facial AD Severity Score of Clear at Week 24 for Participants With Facial AD at Baseline
Ramy czasowe: Baseline and Week 24
|
The severity of facial AD was assessed using the Facial AD Severity Scale (FASS).
The FASS was an instrument used to rate the overall severity of facial AD based on a 5-category scale: clear (0), almost clear (1), mild (2), moderate (3), and severe (4), with higher scores indicating more severe disease.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 24
|
|
Number of Participants Who Achieved Hand AD Severity Score of Clear at Week 24 for Participants With Hand AD at Baseline
Ramy czasowe: Baseline and Week 24
|
The severity of hand AD was assessed using the Hand Atopic Dermatitis Severity Scale (HASS).
The HASS was an instrument used to rate the overall severity of hand AD based on a 5-category scale: clear (0), almost clear (1), mild (2), moderate (3), and severe (4), with higher scores indicating more severe disease.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 24
|
|
Number of Participants Who Achieved ≥ 4-point Reduction From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 24 in Participants With Baseline DLQI ≥ 4
Ramy czasowe: Baseline and Week 24
|
The DLQI was a 10-item, self-administered questionnaire, where the total score ranged from 0 to 30; higher scores represented a greater impact of AD.
It was designed to measure the health-related quality of life of adult patients suffering from skin disease.
The DLQI measured participants' perception of the impact of skin diseases on different aspects of their health-related quality of life over the previous week.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 24
|
|
Change From Baseline in DLQI Score at Week 24
Ramy czasowe: Baseline and Week 24
|
The DLQI was a 10-item, self-administered questionnaire, where the total score ranged from 0 to 30; higher scores represented a greater impact of AD.
It was designed to measure the health-related quality of life of adult patients suffering from skin disease.
The DLQI measured patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the previous week.
Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points.
A negative change from baseline indicated a reduction in the impact of AD on health-related quality of life.
|
Baseline and Week 24
|
|
Number of Participants Who Achieved ≥ 4-point Reduction From Baseline in Patient Oriented Eczema Measure (POEM) Score at Week 24 in Participants With Baseline POEM Score ≥ 4
Ramy czasowe: Baseline and Week 24
|
The POEM was a 7-item validated questionnaire used to assess disease symptoms in children and adults, where the POEM total score ranged from 0 to 28; higher scores represented a greater impact of AD.
It evaluated the time spent in the past week with AD signs and symptoms: individual items of bleeding, oozing, cracked, flaking, and dry/rough skin, and their impact on sleep.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 24
|
|
Change From Baseline in POEM Score at Week 24
Ramy czasowe: Baseline and Week 24
|
The POEM was a 7-item validated questionnaire used to assess disease symptoms in children and adults, where the POEM total score ranged from 0 to 28; higher scores represented a greater impact of AD.
It evaluated the time spent in the past week with AD signs and symptoms: individual items of bleeding, oozing, cracked, flaking, and dry/rough skin, and their impact on sleep.
Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points.
A negative change from baseline indicated a reduction in the impact of AD.
|
Baseline and Week 24
|
|
Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24
Ramy czasowe: Baseline and Week 24
|
AD skin pain was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain.
Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points.
A negative change from baseline indicated a reduction in AD skin pain intensity.
|
Baseline and Week 24
|
|
Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16
Ramy czasowe: Baseline and Week 16
|
AD skin pain was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain.
Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points.
A negative change from baseline indicated a reduction in AD skin pain intensity.
|
Baseline and Week 16
|
|
Number of Participants Who Achieved Hospital Anxiety and Depression Scale (HADS)-Anxiety Subscale Score < 8 at Week 24 in Participants With Baseline HADS-anxiety Subscale Score ≥ 8
Ramy czasowe: Baseline and Week 24
|
HADS was defined as a self-assessment questionnaire used to detect states of anxiety and depression in hospital outpatient settings.
The HADS-Anxiety subscale score ranged from 0 to 21, with higher scores representing a greater impact of AD.
Anxiety severity was categorized as follows: 0 to 7 (Normal), 8 to 10 (Mild), 11 to 14 (Moderate), and 15 to 21 (Severe).
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 24
|
|
Number of Participants Who Achieved HADS-depression Subscale Score < 8 at Week 24 in Participants With Baseline HADS-depression Subscale Score ≥ 8
Ramy czasowe: Baseline and Week 24
|
HADS was defined as a self-assessment questionnaire used to detect states of anxiety and depression in hospital outpatient settings.
The HADS-depression subscale score ranged from 0 to 21, with higher scores representing a greater impact of AD.
Depression severity was categorized as follows: 0 to 7 (Normal), 8 to 10 (Mild), 11 to 14 (Moderate), and 15 to 21 (Severe).
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 24
|
|
Change From Baseline in HADS-anxiety Subscale Score at Week 24
Ramy czasowe: Baseline and Week 24
|
HADS was defined as a self-assessment questionnaire used to detect states of anxiety and depression in hospital outpatient settings.
The HADS-Anxiety subscale score ranged from 0 to 21, with higher scores representing a greater impact of AD.
Anxiety severity was categorized as follows: 0 to 7 (Normal), 8 to 10 (Mild), 11 to 14 (Moderate), and 15 to 21 (Severe).
Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points.
A negative change from baseline indicated a reduction in the impact of AD.
|
Baseline and Week 24
|
|
Change From Baseline in HADS-depression Subscale Score at Week 24
Ramy czasowe: Baseline and Week 24
|
HADS was defined as a self-assessment questionnaire used to detect states of anxiety and depression in hospital outpatient settings.
The HADS-depression subscale score ranged from 0 to 21, with higher scores representing a greater impact of AD.
Depression severity was categorized as follows: 0 to 7 (Normal), 8 to 10 (Mild), 11 to 14 (Moderate), and 15 to 21 (Severe).
Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points.
A negative change from baseline indicated a reduction in the impact of AD.
|
Baseline and Week 24
|
|
Number of Participants Who Achieved a ≥ 8.7-point Reduction From Baseline in SCORAD Total Score at Week 24 in Participants With Baseline SCORAD Total Score ≥ 8.7
Ramy czasowe: Baseline and Week 24
|
The SCORAD total score used to assess the severity of AD using both physician and patient-reported data.
SCORAD total score ranged from 0 to 103 with a higher score indicating more severe AD.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 24
|
|
Number of Participants Who Achieved ≥ 4-point Reduction From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24 in Participants With Baseline Weekly Average of AD Skin Pain NRS Score ≥ 4
Ramy czasowe: Baseline and Week 24
|
AD skin pain was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 24
|
|
Change From Baseline in Severity Scoring (SCORing) of AD (SCORAD) Itch Visual Analogue Scale (VAS) Score at Week 16
Ramy czasowe: Baseline and Week 16
|
The SCORAD Itch VAS was a component of the SCORAD tool used to assess the severity of AD using both physician and patient-reported data.
Itch VAS scale ranged from 0 to 10, with a higher score indicating more severe symptoms of AD.
Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points.
A negative change from baseline indicated a reduction in AD severity.
|
Baseline and Week 16
|
|
Change From Baseline in Weekly Average of Daily Sleep Disturbance NRS Score at Week 24
Ramy czasowe: Baseline and Week 24
|
Average of Daily Sleep Disturbance NRS Score was defined as the mean of daily scores reported by participants in an electronic diary assessing the quality of their sleep over the past 24 hours.
Sleep disturbance was measured using an NRS consisting of a single item ranging from 0 to 10, where 10 indicated the highest level of sleep disturbance.
Participants were asked to rate the intensity of their sleep disturbance using this scale each day.
Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points.
A negative change from baseline indicated a reduction in level of sleep disturbance.
|
Baseline and Week 24
|
|
Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 16
Ramy czasowe: Baseline and Week 16
|
The worst pruritus score was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of itch.
Participants were asked to rate the intensity of their worst itch using this scale.
Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (worst observation carried forward [WOCF]) to all subsequent time points.
A negative change from baseline indicated a reduction in itch intensity.
|
Baseline and Week 16
|
|
Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24
Ramy czasowe: Baseline and Week 24
|
The worst pruritus score was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of itch.
Participants were asked to rate the intensity of their worst itch using this scale.
Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points.
A negative change from baseline indicated a reduction in itch intensity.
|
Baseline and Week 24
|
|
Change From Baseline in SCORAD Itch VAS Score at Week 24
Ramy czasowe: Baseline and Week 24
|
The SCORAD Itch VAS was a component of the SCORAD tool used to assess the severity of AD using both physician and patient-reported data.
Itch VAS scale ranged from 0 to 10, with a higher score indicating severe symptoms of AD.
Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points.
A negative change from baseline indicated a reduction in AD severity.
|
Baseline and Week 24
|
|
Number of Participants Who Achieved ≥ 4-point Reduction From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16 in Participants With Baseline Weekly Average of AD Skin Pain NRS Score ≥ 4
Ramy czasowe: Baseline and Week 16
|
AD skin pain was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 16
|
|
Number of Participants Who Achieved ≥ 3-point Reduction From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24 in Participants With Baseline Weekly Average of Daily AD Skin Pain NRS Score ≥ 3
Ramy czasowe: Baseline and Week 24
|
AD skin pain was assessed using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 24
|
|
Number of Participants Who Achieved ≥ 3-point Reduction From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16 in Participants With Baseline Weekly Average of Daily AD Skin Pain NRS Score ≥ 3
Ramy czasowe: Baseline and Week 16
|
AD skin pain was assessed using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 16
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Dyrektor Studium: MD, Amgen
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Przydatne linki
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
21 lutego 2023
Zakończenie podstawowe (Rzeczywisty)
15 września 2024
Ukończenie studiów (Rzeczywisty)
4 grudnia 2024
Daty rejestracji na studia
Pierwszy przesłany
2 lutego 2023
Pierwszy przesłany, który spełnia kryteria kontroli jakości
2 lutego 2023
Pierwszy wysłany (Rzeczywisty)
13 lutego 2023
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
6 sierpnia 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
4 sierpnia 2026
Ostatnia weryfikacja
1 lipca 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Choroby genetyczne, wrodzone
- Choroby układu odpornościowego
- Nadwrażliwość, natychmiastowa
- Nadwrażliwość
- Choroby skórne
- Choroby skóry, genetyczne
- Choroby skóry, egzema
- Zapalenie skóry
- Wrodzone, dziedziczne i noworodkowe choroby i nieprawidłowości
- Choroby skóry i tkanki łącznej
- Zapalenie skóry, atopowe
- Wyprysk
Inne numery identyfikacyjne badania
- 20210144
- 2022-501585-22-00 (Identyfikator rejestru: CTIS (EU))
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
TAK
Opis planu IPD
Pozbawione elementów umożliwiających identyfikację dane poszczególnych pacjentów dla zmiennych niezbędnych do rozwiązania konkretnego pytania badawczego w zatwierdzonym wniosku o udostępnienie danych.
Ramy czasowe udostępniania IPD
Prośby o udostępnienie danych dotyczące tego badania będą rozpatrywane począwszy od 18 miesięcy po zakończeniu badania i albo 1) produkt i wskazanie uzyskały pozwolenie na dopuszczenie do obrotu zarówno w USA, jak i Europie, albo 2) badania kliniczne produktu i/lub wskazania zostały przerwane a dane nie będą przekazywane organom regulacyjnym.
Nie ma ostatecznej daty kwalifikowalności do przesłania prośby o udostępnienie danych dla tego badania.
Kryteria dostępu do udostępniania IPD
Wykwalifikowani badacze mogą złożyć wniosek zawierający cele badawcze, produkt(y) firmy Amgen i badanie/badania firmy Amgen w zakresie, punkty końcowe/wyniki będące przedmiotem zainteresowania, plan analizy statystycznej, wymagania dotyczące danych, plan publikacji oraz kwalifikacje badacza(ów).
Ogólnie rzecz biorąc, firma Amgen nie przyjmuje zewnętrznych próśb o dane poszczególnych pacjentów w celu ponownej oceny kwestii bezpieczeństwa i skuteczności, które zostały już uwzględnione na etykiecie produktu.
Wnioski są rozpatrywane przez komitet doradców wewnętrznych.
Jeśli nie zostanie to zatwierdzone, niezależny panel kontrolny ds. udostępniania danych przeprowadzi arbitraż i podejmie ostateczną decyzję.
Po zatwierdzeniu informacje niezbędne do odpowiedzi na pytanie badawcze zostaną dostarczone zgodnie z warunkami umowy o udostępnianiu danych.
Może to obejmować zanonimizowane dane poszczególnych pacjentów i/lub dostępne dokumenty potwierdzające, zawierające fragmenty kodu analizy, jeśli podano w specyfikacjach analizy.
Dalsze szczegóły są dostępne pod poniższym adresem URL.
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
- ICF
- CSR
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Tak
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .