En studie som utvärderar Rocatinlimab vid måttlig till svår atopisk dermatit (ROCKET-IGNITE) (ROCKET-Ignite)
25 juni 2026 uppdaterad av: Amgen
En fas 3, 24-veckors, randomiserad, placebokontrollerad, dubbelblind studie för att bedöma effektiviteten, säkerheten och toleransen av rocatinlimab (AMG 451) monoterapi hos vuxna patienter med måttlig till svår atopisk dermatit (AD)
Syftet med denna studie är att utvärdera effektiviteten och säkerheten av rocatinlimab vid monoterapibehandling.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
769
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Buenos Aires
-
CABA, Buenos Aires, Argentina, C1027AAP
- CINME - Centro De Investigaciones Metabolicas
-
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1426ABP
- Fundacion Respirar
-
Derqui, Pilar, Buenos Aires, Argentina, B1629ODT
- Hospital Universitario Austral
-
San Miguel, Buenos Aires, Argentina, 1663
- Centro Dermatologico Schejtman
-
-
Distrito Federal
-
Buenos Aires, Distrito Federal, Argentina, 1425
- Instituto de Neumonología Y Dermatología
-
Buenos Aires, Distrito Federal, Argentina, 1425
- InAER - Investigaciones en Alergia y Enfermedades Respiratorias
-
CABA, Distrito Federal, Argentina, C1012AAY
- Conexa Investigacion Clinica SA
-
-
Santa Fe Province
-
Rosario, Santa Fe Province, Argentina, 2000
- Fundacion Estudios Clinicos
-
Rosario, Santa Fe Province, Argentina, 2000
- Instituto de Diagnostico Abc American British Cowdray
-
-
-
-
-
Rio de Janeiro, Brasilien, 20241-180
- IBPClin Instituto Brasil de Pesquisa Clinica
-
São Paulo, Brasilien, 06454-010
- Alergoalfa Nucleo Diagnostico Tratamento e Pesquisa Clinica em Alergia
-
-
Rio Grande do Sul
-
Porto Alegre, Rio Grande do Sul, Brasilien, 90035-903
- Hospital de Clinicas de Porto Alegre
-
Porto Alegre, Rio Grande do Sul, Brasilien, 90160-093
- Hospital Ernesto Dornelles
-
-
São Paulo
-
Botucatu, São Paulo, Brasilien, 18618-686
- Upeclin-Pesq Clin FacMed Botucatu
-
Santo André, São Paulo, Brasilien, 09060-870
- Fundacao Abc - Centro Univ Fmabc
-
Santo André, São Paulo, Brasilien, 09030-010
- Hosp e Maternidade Dr Christovao da Gama
-
Sorocaba, São Paulo, Brasilien, 18040-425
- Consultoria Medica e Pesquisa Clinica Cmpc
-
-
-
-
Alabama
-
Birmingham, Alabama, Förenta staterna, 35244
- Cahaba Dermatology and Skin Health Center
-
-
Arizona
-
Phoenix, Arizona, Förenta staterna, 85032
- Alliance Dermatology and Mohs Center
-
-
California
-
Anaheim, California, Förenta staterna, 92801
- Anaheim Clinical Trials
-
Fountain Valley, California, Förenta staterna, 92708
- First OC Dermatology
-
Glendale, California, Förenta staterna, 91203
- Kaiser Permanente - Glendale Medical Center
-
Long Beach, California, Förenta staterna, 90805
- Long Beach Research Institute
-
Los Angeles, California, Förenta staterna, 90045
- Dermatology Research Associates
-
Los Angeles, California, Förenta staterna, 90027
- Kaiser Permanente Los Angeles Medical Center
-
Sherman Oaks, California, Förenta staterna, 91403
- Cura Clinical Research
-
-
Colorado
-
Centennial, Colorado, Förenta staterna, 80112
- IMMUNOe Research Centers
-
-
Florida
-
Boca Raton, Florida, Förenta staterna, 33486
- Skin Care Research Incorporated
-
Delray Beach, Florida, Förenta staterna, 33484
- Palm Beach Dermatology Group
-
Homestead, Florida, Förenta staterna, 33030
- Global Research Associates
-
Miami, Florida, Förenta staterna, 33175
- Healthy Life Research
-
Miami Lakes, Florida, Förenta staterna, 33014
- Savin Medical Group LLC
-
Naples, Florida, Förenta staterna, 34102
- Kirsch Dermatology LLC
-
Orlando, Florida, Förenta staterna, 32819
- Pure Skin Dermatology and Aesthetics
-
St. Petersburg, Florida, Förenta staterna, 33709
- Industrial Medicine Associates Ima Clinical Research Inc
-
Tampa, Florida, Förenta staterna, 33606
- Genesis Clinical Research LLC
-
-
Idaho
-
Boise, Idaho, Förenta staterna, 83706
- Treasure Valley Medical Research
-
-
Illinois
-
Chicago, Illinois, Förenta staterna, 60611
- DeNova Research
-
West Dundee, Illinois, Förenta staterna, 60118
- Dundee Dermatology
-
-
Indiana
-
Plainfield, Indiana, Förenta staterna, 46168
- The Indiana Clinical Trials Center PC
-
-
Maryland
-
Chevy Chase, Maryland, Förenta staterna, 20815
- Institute for Asthma and Allergy
-
Towson, Maryland, Förenta staterna, 21204
- Continental Clinical Solutions, LLC
-
-
Michigan
-
Detroit, Michigan, Förenta staterna, 48202
- Henry Ford Health System
-
Flint, Michigan, Förenta staterna, 48532
- Onyx Clinical Research
-
-
Missouri
-
Lee's Summit, Missouri, Förenta staterna, 64064
- Dermatology and Skin Cancer Center of Lees Summit
-
-
Nevada
-
Las Vegas, Nevada, Förenta staterna, 89106
- Jubilee Clinical Research Inc
-
-
New Hampshire
-
Portsmouth, New Hampshire, Förenta staterna, 03801
- Allcutis Research, Llc - Portsmouth
-
-
New Jersey
-
Cherry Hill, New Jersey, Förenta staterna, 08034
- Continental Clinical Solutions - Cherry Hill
-
-
New York
-
Hartsdale, New York, Förenta staterna, 10530
- Industrial Medicine Associates Ima Clinical Research Inc
-
New York, New York, Förenta staterna, 10075
- Sadick Research Group
-
-
North Carolina
-
Charlotte, North Carolina, Förenta staterna, 28277
- Dermatology Specialists of Charlotte
-
Charlotte, North Carolina, Förenta staterna, 28277
- Onsite Clinical Solutions
-
Wilmington, North Carolina, Förenta staterna, 28405
- Wilmington Dermatology Center
-
Winston-Salem, North Carolina, Förenta staterna, 27103
- The Skin Surgery Center for Clinical Research
-
-
Ohio
-
Boardman, Ohio, Förenta staterna, 44512
- Optima Research
-
Columbus, Ohio, Förenta staterna, 43213
- ClinOhio Research Services
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Förenta staterna, 73118
- Unity Clinical Research
-
Tulsa, Oklahoma, Förenta staterna, 74132
- Dermatology Research Center of Oklahoma, PLLC
-
Tulsa, Oklahoma, Förenta staterna, 74137
- Essential Medical Research LLC
-
-
Oregon
-
Portland, Oregon, Förenta staterna, 97239
- Oregon Health and Science University
-
-
Pennsylvania
-
Sugarloaf, Pennsylvania, Förenta staterna, 18249
- DermDox Dermatology, LLC
-
-
Tennessee
-
Hermitage, Tennessee, Förenta staterna, 37076
- Cumberland Skin Center
-
-
Texas
-
Dallas, Texas, Förenta staterna, 75230
- Dermatology Treatment and Research Center PA
-
The Woodlands, Texas, Förenta staterna, 77380
- The Woodlands Dermatology Associates
-
-
Virginia
-
Lynchburg, Virginia, Förenta staterna, 24501
- Education and Research Foundation Inc
-
-
Washington
-
Mill Creek, Washington, Förenta staterna, 98012
- Frontier Derm Partners
-
-
West Virginia
-
Morgantown, West Virginia, Förenta staterna, 26505
- West Virginia Research Institute
-
-
-
-
-
Athens, Grekland, 12462
- University General Hospital Attikon
-
Athens, Grekland, 11521
- Athens Naval Hospital
-
Athens, Grekland, 16121
- Andreas Syngros Hospital Of Venereal And Dermatological Diseases
-
Athens, Grekland, 11527
- Thoracic General Hospital Of Athens Sotiria
-
Ioannina, Grekland, 45500
- University General Hospital Of Ioannina
-
Larissa, Grekland, 41110
- General University Hospital of Larissa
-
Thessaloniki, Grekland, 56403
- Papageorgiou General Hospital
-
-
-
-
-
Chieti, Italien, 66100
- Universita degli Studi Gabriele D Annunzio di Chieti e Pescara
-
Milan, Italien, 20122
- Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
-
Perugia, Italien, 06156
- Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia
-
Roma, Italien, 00161
- Azienda Ospedaliera Policlinico Umberto I
-
Torino, Italien, 10126
- Azienda Ospedaliera Citta Della Salute E Della Scienza Di Torino
-
-
-
-
Aichi-ken
-
Nagakute-shi, Aichi-ken, Japan, 480-1195
- Aichi Medical University Hospital
-
Nagoya, Aichi-ken, Japan, 467-8602
- Nagoya City University Hospital
-
Nagoya, Aichi-ken, Japan, 464-0821
- Central Clinic
-
Nagoya, Aichi-ken, Japan, 457-8510
- Japan Community Healthcare Organization Chukyo Hospital
-
-
Fukuoka
-
Fukuoka, Fukuoka, Japan, 819-0373
- Matsuo Clinic
-
Fukuoka, Fukuoka, Japan, 814-0180
- Fukuoka University Hospital
-
-
Fukushima
-
Fukushima, Fukushima, Japan, 960-1295
- Fukushima Medical University Hospital
-
-
Hokkaido
-
Asahikawa-shi, Hokkaido, Japan, 070-8610
- Asahikawa City Hospital
-
-
Ibaraki
-
Inashiki-gun, Ibaraki, Japan, 300-0395
- Tokyo Medical University Ibaraki Medical Center
-
-
Ishikawa-ken
-
Nonoichi-shi, Ishikawa-ken, Japan, 921-8801
- Kaji Dermatology Clinic
-
-
Iwate
-
Morioka, Iwate, Japan, 020-8505
- Iwate Medical University Uchimaru Medical Center
-
-
Kagawa-ken
-
Marugame-shi, Kagawa-ken, Japan, 763-0074
- Takeoka Dermatology Clinic
-
-
Kanagawa
-
Kawasaki-shi, Kanagawa, Japan, 211-8533
- Nippon Medical School Musashikosugi Hospital
-
-
Kyoto
-
Kyoto, Kyoto, Japan, 607-8062
- Rakuwakai Otowa Hospital
-
Kyoto, Kyoto, Japan, 602-8566
- University Hospital Kyoto Prefectural University of Medicine
-
-
Osaka
-
Izumiotsu-shi, Osaka, Japan, 595-0025
- Mochida Dermatology Clinic
-
-
Tochigi
-
Shimotsuga-gun, Tochigi, Japan, 321-0293
- Dokkyo Medical University Hospital
-
-
Tokyo
-
Itabashi-ku, Tokyo, Japan, 173-8610
- Nihon University Itabashi Hospital
-
Itabashi-ku, Tokyo, Japan, 173-8606
- Teikyo University Hospital
-
-
-
-
Alberta
-
Edmonton, Alberta, Kanada, T6G 1C3
- Alberta Derma Surgery Centre
-
Edmonton, Alberta, Kanada, T6H 4J8
- Vida Clinical Research
-
-
Ontario
-
Ajax, Ontario, Kanada, L1S 7K8
- CCA Medical Research Corporation
-
Barrie, Ontario, Kanada, L4M 7G1
- SimcoDerm Medical and Surgical Dermatology Centre
-
Hamilton, Ontario, Kanada, L8L 3C3
- LEADER research
-
Mississauga, Ontario, Kanada, L4Y 4C5
- DermEdge Research Incorporated
-
North York, Ontario, Kanada, M3B 3S6
- Gordon Sussman Clinical Research Incorporated
-
North York, Ontario, Kanada, M3B 0A7
- Canadian Dermatology Centre
-
Richmond Hill, Ontario, Kanada, L4E 4L6
- Oak Ridges Aesthetics Centre
-
-
Quebec
-
Montreal, Quebec, Kanada, H2X 2V1
- Innovaderm Research Inc
-
Québec, Quebec, Kanada, G1G 3Y8
- Recherche Clinique Sigma Incorporated
-
-
Saskatchewan
-
Saskatoon, Saskatchewan, Kanada, S7K 2C1
- Skinsense Medical Research
-
-
-
-
-
Beijing, Kina, 100044
- Peking University Peoples Hospital
-
Shanghai, Kina, 200443
- Shanghai Skin Disease Hospital
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, Kina, 100191
- Peking University Third Hospital
-
Beijing, Beijing Municipality, Kina, 100050
- Beijing Friendship hospital, Capital Medical University
-
-
Fujian
-
Fuzhou, Fujian, Kina, 350000
- The First Affiliated Hospital of Fujian Medical University
-
-
Guangdong
-
Guangzhou, Guangdong, Kina, 510091
- Dermatology Hospital of Southern Medical University
-
Guangzhou, Guangdong, Kina, 510120
- Sun Yat-sen Memorial Hospital Sun Yat-sen university
-
Guangzhou, Guangdong, Kina, 510080
- The First Affiliated Hospital ,Sun-Yat Sen University
-
-
Hebei
-
Shijiazhuang, Hebei, Kina, 050000
- The First Hospital of Hebei Medical University
-
-
Henan
-
Nanyang, Henan, Kina, 473002
- Nanyang First Peoples Hospital
-
Sanmenxia, Henan, Kina, 472099
- Sanmenxia Central Hospital
-
-
Hubei
-
Wuhan, Hubei, Kina, 430022
- Union Hospital Tongji Medical College Huazhong University Of Science And Technology
-
-
Hunan
-
Changsha, Hunan, Kina, 410011
- The Second Xiangya Hospital of Central South University
-
-
Jiangsu
-
Jiangyin, Jiangsu, Kina, 214400
- Jiangyin Hospital of Traditional Chinese Medicine
-
Wuxi, Jiangsu, Kina, 241023
- Wuxi Peoples Hospital
-
-
Jiangxi
-
Nanchang, Jiangxi, Kina, 330000
- Dermatology Hospital of Jiangxi Province
-
-
Jilin
-
Changchun, Jilin, Kina, 130021
- The First Hospital of Jilin University
-
-
Liaoning
-
Shenyang, Liaoning, Kina, 110001
- The First Hospital of China Medical University
-
-
Sichuan
-
Chengdu, Sichuan, Kina, 610021
- Chengdu Second Peoples Hospital
-
-
Zhejiang
-
Hangzhou, Zhejiang, Kina, 310003
- The First Affiliated Hospital Zhejiang University School of Medicine
-
Hangzhou, Zhejiang, Kina, 310020
- Affiliated Hangzhou First Peoples Hospital，Zhejiang University School of Medicine
-
Hangzhou, Zhejiang, Kina, 310004
- Zhejiang Provincial Peoples Hospital
-
Taizhou, Zhejiang, Kina, 318000
- Taizhou Central Hospital
-
-
-
-
-
Ivanić-Grad, Kroatien, 10310
- Special Hospital for Medical Rehabilitation Naftalan
-
Zagreb, Kroatien, 10000
- University Hospital Centre Zagreb
-
Zagreb, Kroatien, 10000
- Sestre milosrdnice University Hospital Center
-
-
-
-
-
Riga, Lettland, 1003
- Outpatient clinic Veselibas Centrs 4
-
Riga, Lettland, LV-1013
- Outpatient clinic Veselibascentrs 4
-
Talsi, Lettland, 3201
- Smite Aija practice in dermatology and venerology
-
-
-
-
-
Born, Nederländerna, 6121 XK
- PreCare Trial and Recruitment
-
-
-
-
-
Gdansk, Polen, 80-280
- AKK Medical Spolka z ograniczona odpowiedzialnoscia Centrum Medyczne Tu sie leczy
-
Katowice, Polen, 40-611
- Centrum Medyczne Angelius Provita
-
Lublin, Polen, 20-080
- Centrum Zdrowia i Urody Maxxmed
-
Malbork, Polen, 82-200
- Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Spzoo
-
Nowa Sól, Polen, 67-100
- Twoja Przychodnia NCM
-
Poznan, Polen, 61-293
- Twoja Przychodnia PCM
-
Szczecin, Polen, 71-500
- Twoja Przychodnia SCM
-
Tarnów, Polen, 33-100
- Alergo-Med Specjalistyczna Przychodnia Lekarska Spzoo
-
Warsaw, Polen, 02-962
- Royalderm Agnieszka Nawrocka
-
Wroclaw, Polen, 50-450
- Dermatologiczna Praktyka Lekarska Michal Torz Dermaceum Centrum Badan Klinicznych
-
-
-
-
-
Lisbon, Portugal, 1998-018
- Hospital CUF Descobertas
-
Lisbon, Portugal, 1500-458
- Hospital Lusiadas Lisboa
-
Matosinhos Municipality, Portugal, 4464-513
- Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano
-
Porto, Portugal, 4099-001
- Unidade Local de Saude de Santo Antonio, EPE - Hospital de Santo Antonio
-
-
-
-
-
San Juan, Puerto Rico, 00909
- Clinical Research of Puerto Rico
-
-
-
-
-
Banská Bystrica, Slovakien, 975 17
- Fakultna Nemocnica s poliklinikou F D Roosevelta Banska Bystrica
-
Bratislava, Slovakien, 851 01
- Derma therapy, spol s ro
-
Svidník, Slovakien, 089 01
- Sanare spol sro
-
Topoľčany, Slovakien, 955 01
- Kaderma Majtan, sro
-
Trnava, Slovakien, 917 75
- Fakultna Nemocnica Trnava
-
-
-
-
-
Madrid, Spanien, 28006
- Hospital Universitario de La Princesa
-
Madrid, Spanien, 28031
- Hospital Universitario Infanta Leonor
-
-
Andalusia
-
Córdoba, Andalusia, Spanien, 14004
- Hospital Universitario Reina Sofia
-
-
Aragon
-
Zaragoza, Aragon, Spanien, 50009
- Hospital Universitario Miguel Servet
-
-
Canary Islands
-
Las Palmas de Gran Canaria, Canary Islands, Spanien, 35010
- Hospital Universitario de Gran Canaria Doctor Negrin
-
-
Catalonia
-
Badalona, Catalonia, Spanien, 08916
- Hospital Universitari Germans Trias i Pujol
-
L'Hospitalet de Llobregat, Catalonia, Spanien, 08907
- Hospital Universitari de Bellvitge
-
-
Galicia
-
Pontevedra, Galicia, Spanien, 36001
- Hospital Clínico Universitario de Santiago
-
-
Madrid
-
Pozuelo de Alarcón, Madrid, Spanien, 28223
- Hospital Universitario Quironsalud Madrid
-
-
Valencia
-
Valencia, Valencia, Spanien, 46026
- Hospital Universitari i Politecnic La Fe
-
-
-
-
-
Ansansi, Gyeonggido, Sydkorea, 15355
- Korea University Ansan Hospital
-
Incheon, Sydkorea, 21431
- The Catholic University of Korea Incheon St Marys Hospital
-
Seoul, Sydkorea, 03080
- Seoul National University Hospital
-
Seoul, Sydkorea, 05505
- Asan Medical Center
-
Seoul, Sydkorea, 08308
- Korea University Guro Hospital
-
Seoul, Sydkorea, 04564
- National Medical Center
-
-
-
-
-
Kaohsiung City, Taiwan, 83301
- Kaohsiung Chang Gung Memorial Hospital
-
Tainan, Taiwan, 70403
- National Cheng Kung University Hospital
-
Taipei, Taiwan, 10002
- National Taiwan University Hospital
-
Taipei, Taiwan, 11217
- Taipei Veterans General Hospital
-
Taipei, Taiwan, 10449
- MacKay Memorial Hospital Taipei Branch
-
Taoyuan, Taiwan, 33305
- Linkou Chang Gung Memorial Hospital
-
-
-
-
-
Náchod, Tjeckien, 547 01
- Dermamedica, sro
-
Ostrava, Tjeckien, 702 00
- CCR Ostrava sro
-
Pardubice, Tjeckien, 530 02
- Pratia Pardubice as
-
Prague, Tjeckien, 180 81
- Fakultní nemocnice Bulovka
-
Prague, Tjeckien, 100 00
- Clintrial sro
-
Prague, Tjeckien, 130 00
- Pratia Prague sro
-
Ústí nad Labem, Tjeckien, 401 13
- Krajska zdravotni as - Masarykova nemocnice Usti nad Labem oz
-
-
-
-
-
Berlin, Tyskland, 10117
- Charite - Universitaetsmedizin Berlin, Campus Mitte
-
Blankenfelde-Mahlow, Tyskland, 15831
- Dermatologische Gemeinschaftspraxis-Mahlow
-
Bochum, Tyskland, 44793
- Hautarztpraxis Dr Niesmann und Dr Othlinghaus
-
Darmstadt, Tyskland, 64283
- Rosenpark Research GmbH
-
Dresden, Tyskland, 01307
- Universitaetsklinikum Dresden
-
Düsseldorf, Tyskland, 40225
- Heinrich-Heine-Universitaet Duesseldorf - Universitaetsklinikum Duesseldorf
-
Essen, Tyskland, 45174
- Universitaetsklinikum Essen
-
Hamburg, Tyskland, 20246
- Institute for Health Services Research in Dermatology and Nursing
-
Heidelberg, Tyskland, 69120
- Universitaetsklinikum Heidelberg
-
Stuttgart, Tyskland, 70178
- Hautarztpraxis Dres Leitz und Kollegen
-
Tübingen, Tyskland, 72076
- Universitaetsklinikum Tuebingen
-
Wuppertal, Tyskland, 42287
- CentroDerm GmbH
-
-
-
-
-
Veszprém, Ungern, 8200
- MedMare Bt
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 100 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Beskrivning
Inklusionskriterier:
- Ålder ≥ 18 år med diagnosen AD enligt AAD Consensus Criteria (2014) närvarande i minst 6 månader
- Historik med otillräckligt svar på TCS (Topical Corticosteroid) med medel eller högre styrka inom 6 månader (med eller utan topiska calcineurin-hämmare [TCI])
- EASI-poäng ≥16
- vIGA-AD-poäng ≥3
- ≥10 % kroppsyta (BSA) av AD-inblandning
- Värsta klåda numerisk betygsskala ≥ 4
Exklusions kriterier:
- Behandling med en biologisk produkt inom 12 veckor eller 5 halveringstider, beroende på vilken som är längre, före dag 1
Behandling med någon av följande mediciner eller terapier inom 4 veckor eller 5 halveringstider, beroende på vilken som är längre, före dag 1:
- Systemiska kortikosteroider
- Systemiska immunsuppressiva medel
- Fototerapi
- Janus kinashämmare
Behandling med någon av följande mediciner eller terapier inom 1 vecka, före dag 1:
- TCS av vilken styrka som helst
- TCI
- Antiklåda läkemedel
- Topikala fosfodiesteras typ 4-hämmare
- Andra topiska immunsuppressiva medel
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Arm A
Rocatinlimab Dos 1 var 4:e vecka (Q4W) + laddningsdos vid vecka 2
|
Deltagarna kommer att få Rocatinlimab subkutant.
Andra namn:
|
|
Experimentell: Arm B
Rocatinlimab Dos 2 Q4W + laddningsdos vid vecka 2
|
Deltagarna kommer att få Rocatinlimab subkutant.
Andra namn:
|
|
Placebo-jämförare: Arm C
Placebo Q4W+ laddningsdos vid vecka 2
|
Deltagarna kommer att få placebo subkutant.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
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
Tidsram: 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," the participant met rIGA 0/1; if "No," they did not.
If vIGA-AD = 0, the participant met rIGA 0/1.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 24
|
|
Number of Participants Who Achieved ≥ 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75) at Week 24
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of Participants Who Achieved EASI 75 at Week 16
Tidsram: 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 ≥ 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
|
Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 16
Tidsram: 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 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
Tidsram: 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 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
|
|
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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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 ≥ 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
Tidsram: 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
|
|
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
Tidsram: 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 HADS-depression Subscale Score < 8 at Week 24 in Participants With Baseline HADS-depression Subscale Score ≥ 8
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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 vIGA-AD 0/1 at Week 16
Tidsram: 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 ≥ 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
Tidsram: 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
Tidsram: 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 SCORAD Itch VAS Score at Week 24
Tidsram: 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 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 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
Tidsram: 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.
Only participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 16
|
|
Change From Baseline in Weekly Average of Daily Sleep Disturbance NRS Score at Week 24
Tidsram: 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
|
|
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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: MD, Amgen
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Guttman-Yassky E, Simpson E, Bissonnette R, Eichenfield LF, Kabashima K, Luna PC, Hercogova JT, Spelman L, Worm M, Esfandiari E, Arai T, Mano H, Charuworn P, Wang A, Kricorian G. ROCKET: a phase 3 program evaluating the efficacy and safety of rocatinlimab in moderate-to-severe atopic dermatitis. Immunotherapy. 2025 Feb;17(2):83-94. doi: 10.1080/1750743X.2025.2464528. Epub 2025 Feb 26.
- Guttman-Yassky E, Kabashima K, Worm M, Luna PC, Hong HC, Chovatiya R, Bernstein JA, Kern JS, Ehst BD, Magnolo N, Herranz-Pinto P, Stein Gold L, Sofen H, Pink AE, Esfandiari E, Arai T, Yang Y, Shi R, Barragan C, Kricorian G, Schwartz-Sagi L, Bissonnette R. Efficacy and safety of rocatinlimab for the treatment of moderate-to-severe atopic dermatitis in ROCKET-IGNITE and ROCKET-HORIZON: two global, double-blind, placebo-controlled, randomised phase 3 clinical trials. Lancet. 2026 Jan 3;407(10523):53-66. doi: 10.1016/S0140-6736(25)01865-3. Epub 2025 Nov 25.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
31 maj 2022
Primärt slutförande (Faktisk)
28 november 2024
Avslutad studie (Faktisk)
13 januari 2025
Studieregistreringsdatum
Först inskickad
24 maj 2022
Först inskickad som uppfyllde QC-kriterierna
31 maj 2022
Första postat (Faktisk)
1 juni 2022
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
23 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
25 juni 2026
Senast verifierad
1 februari 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 20210142
- 2022-501540-15-00 (Ctis)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
Avidentifierade individuella patientdata för variabler som är nödvändiga för att hantera den specifika forskningsfrågan i en godkänd begäran om datadelning.
Tidsram för IPD-delning
Begäranden om datadelning relaterade till denna studie kommer att övervägas från och med 18 månader efter att studien har avslutats och antingen 1) produkten och indikationen har beviljats marknadsföringstillstånd i både USA och Europa eller 2) klinisk utveckling av produkten och/eller indikationen upphör. och uppgifterna kommer inte att lämnas till tillsynsmyndigheter.
Det finns inget slutdatum för behörighet att skicka in en begäran om datadelning för denna studie.
Kriterier för IPD Sharing Access
Kvalificerade forskare kan lämna in en begäran som innehåller forskningsmålen, Amgen-produkten/-erna och Amgen-studien/studierna i omfattning, slutpunkter/resultat av intresse, statistisk analysplan, datakrav, publiceringsplan och forskarens/forskarnas kvalifikationer.
I allmänhet beviljar Amgen inte externa förfrågningar om individuell patientdata i syfte att omvärdera säkerhets- och effektfrågor som redan behandlats i produktmärkningen.
Förfrågningar granskas av en kommitté av interna rådgivare.
Om det inte godkänns kommer en oberoende granskningspanel för datadelning att skilje och fatta det slutliga beslutet.
Vid godkännande kommer information som är nödvändig för att hantera forskningsfrågan att tillhandahållas enligt villkoren i ett datadelningsavtal.
Detta kan inkludera anonymiserade individuella patientdata och/eller tillgängliga stöddokument, innehållande fragment av analyskod där de finns i analysspecifikationerna.
Mer information finns på webbadressen nedan.
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- ICF
- CSR
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .