A Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-ASCEND)

March 27, 2024 updated by: Amgen

A Phase 3, Multicenter, Double-blind Maintenance Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-ASCEND)

The primary objective of this study is to describe the long-term safety and tolerability of rocatinlimab in participants with moderate-to-severe AD.

Study Overview

Status

Recruiting

Conditions

Atopic Dermatitis

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

2200

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Amgen Call Center
Phone Number: 866-572-6436
Email: medinfo@amgen.com

Study Locations

Argentina
- Buenos Aires
  - Caba, Buenos Aires, Argentina, C1027AAP
    - Recruiting
    - Cinme - Centro de Investigaciones Metabolicas
  - Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1426ABP
    - Recruiting
    - Fundacion Respirar
  - La Plata, Buenos Aires, Argentina, B1902COS
    - Recruiting
    - Framingham Centro Medico
- Distrito Federal
  - Caba, Distrito Federal, Argentina, C1012AAY
    - Recruiting
    - Conexa Investigacion Clinica SA
  - Ciudad Autonoma de Buenos Aires, Distrito Federal, Argentina, 1425
    - Recruiting
    - Instituto de Neumonologia y Dermatologia
  - Ciudad Autonoma de Buenos Aires, Distrito Federal, Argentina, 1425
    - Recruiting
    - InAER - Investigaciones en Alergia y Enfermedades Respiratorias
  - Ciudad Autonoma de Buenos Aires, Distrito Federal, Argentina, 1425
    - Recruiting
    - Psoriahue Medicina Interdisciplinaria SRL
  - Ciudad Autonoma de Buenos Aires, Distrito Federal, Argentina, 1414
    - Recruiting
    - Care- Centro de Alergia y Enfermedades Respiratorias
  - Ciudad Autonoma de Buenos Aires, Distrito Federal, Argentina, 1121
    - Recruiting
    - Fundacion CIDEA
  - Ciudad Autonoma de Buenos Aires, Distrito Federal, Argentina, 1054
    - Recruiting
    - Buenos Aires Skin SA
- Santa Fe
  - Rosario, Santa Fe, Argentina, 2000
    - Recruiting
    - Centro de Investigaciones Clinicas Instituto Especialidades De La Salud De Rosario
  - Rosario, Santa Fe, Argentina, 2000
    - Recruiting
    - Instituto de Diagnostico Abc American British Cowdray
Australia
- New South Wales
  - Kogarah, New South Wales, Australia, 2217
    - Recruiting
    - Premier Specialists
  - Kogarah, New South Wales, Australia, 2217
    - Recruiting
    - St George Dermatology and Skin Cancer Centre
- Queensland
  - Benowa, Queensland, Australia, 4217
    - Recruiting
    - The Skin Centre
  - South Brisbane, Queensland, Australia, 4101
    - Recruiting
    - Princess Alexandra Hospital
- Victoria
  - Box Hill, Victoria, Australia, 3128
    - Recruiting
    - Box Hill Hospital
  - Camberwell, Victoria, Australia, 3124
    - Recruiting
    - Emeritus Research Melbourne
  - Carlton, Victoria, Australia, 3053
    - Recruiting
    - Skin Health Institute
  - Melbourne, Victoria, Australia, 3004
    - Recruiting
    - The Alfred Hospital
  - Parkville, Victoria, Australia, 3050
    - Recruiting
    - The Royal Melbourne Hospital
Austria
- - Graz, Austria, 8036
    - Recruiting
    - Medizinische Universitaet Graz
  - Salzburg, Austria, 5020
    - Recruiting
    - Landeskrankenhaus Salzburg
Belgium
- - Maldegem, Belgium, 9990
    - Recruiting
    - Dermatologie Maldegem
Brazil
- - Rio de Janeiro, Brazil, 20241-180
    - Recruiting
    - IBPClin Instituto Brasil de Pesquisa Clinica
- Paraná
  - Curitiba, Paraná, Brazil, 80030-110
    - Recruiting
    - Ceti Centro Est Terap Inovadoras
- Rio Grande Do Sul
  - Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
    - Recruiting
    - Hospital de Clinicas de Porto Alegre
- São Paulo
  - Santo Andre, São Paulo, Brazil, 09060-870
    - Recruiting
    - Fundacao Abc - Centro Univ Fmabc
  - Sao Bernardo do Campo, São Paulo, Brazil, 09715-090
    - Recruiting
    - Centro Multidisciplinar de Estudos Clinicos - Cemec
  - Sorocaba, São Paulo, Brazil, 18040-425
    - Recruiting
    - Consultoria Medica e Pesquisa Clinica Cmpc
Canada
- - Quebec, Canada, G1V 4X7
    - Recruiting
    - Centre de Recherche Dermatologique Du Quebec Metropolitain
  - Quebec, Canada, G1G 3Y8
    - Recruiting
    - Recherche Clinique Sigma Incorporated
- Alberta
  - Calgary, Alberta, Canada, T3E 0B2
    - Recruiting
    - Beacon Dermatology
  - Edmonton, Alberta, Canada, T6G 1C3
    - Recruiting
    - Alberta Derma Surgery Centre
  - Edmonton, Alberta, Canada, T6H 4J8
    - Recruiting
    - Vida Clinical Research
  - Edmonton, Alberta, Canada, T5J 3S9
    - Recruiting
    - Laser Rejuvenation Clinics Edmonton D T Incorporated
- British Columbia
  - Kelowna, British Columbia, Canada, V1W 4V5
    - Recruiting
    - Interior Dermatology Centre
  - Surrey, British Columbia, Canada, V3V 0C6
    - Recruiting
    - Enverus Medical Research
  - Surrey, British Columbia, Canada, V3R 6A7
    - Recruiting
    - Doctor Chih-Ho Hong Medical Incorporated
- Manitoba
  - Winnipeg, Manitoba, Canada, R3M 3Z4
    - Recruiting
    - Wiseman Dermatology Research Incorporated
- Ontario
  - Ajax, Ontario, Canada, L1S 7K8
    - Recruiting
    - CCA Medical Research Corporation
  - Barrie, Ontario, Canada, L4M 7G1
    - Recruiting
    - SimcoDerm Medical and Surgical Dermatology Centre
  - Coburg, Ontario, Canada, K9A 4J9
    - Recruiting
    - Skin Health
  - Etobicoke, Ontario, Canada, M8X 1Y9
    - Recruiting
    - Kingsway Clinical Research
  - Hamilton, Ontario, Canada, L8L 3C3
    - Recruiting
    - Leader Research
  - London, Ontario, Canada, N6A 2C2
    - Recruiting
    - Centricity Research London
  - Markham, Ontario, Canada, L3P 1X3
    - Recruiting
    - Lynderm Research Inc
  - Mississauga, Ontario, Canada, L4Y 4C5
    - Recruiting
    - DermEdge Research Incorporated
  - Newmarket, Ontario, Canada, L3Y 5G8
    - Recruiting
    - Dr SK Siddha Medicine Professional Corporation
  - Niagara Falls, Ontario, Canada, L2H 1H5
    - Recruiting
    - Allergy Research Canada Incorporated
  - North Bay, Ontario, Canada, P1B 3Z7
    - Recruiting
    - North Bay Dermatology Centre
  - North York, Ontario, Canada, M3B 0A7
    - Recruiting
    - Canadian Dermatology Centre
  - Oakville, Ontario, Canada, L6J 7W5
    - Recruiting
    - The Centre for Clinical Trials Inc
  - Ottawa, Ontario, Canada, K2C 3N2
    - Recruiting
    - Dermatology Ottawa Research Centre
  - Ottawa, Ontario, Canada, K2C 3N2
    - Recruiting
    - JRB Research Incorporated
  - Peterborough, Ontario, Canada, K9J 5K2
    - Recruiting
    - Skin Centre For Dermatology
  - Richmond Hill, Ontario, Canada, L4B 1A5
    - Recruiting
    - The Centre for Dermatology
  - Richmond Hill, Ontario, Canada, L4E 4L6
    - Recruiting
    - Oak Ridges Aesthetics Centre
  - Richmond Hill, Ontario, Canada, L4C 9M7
    - Recruiting
    - York Dermatology Centre
  - Toronto, Ontario, Canada, M4W 2N4
    - Recruiting
    - Research Toronto
  - Toronto, Ontario, Canada, M3H 5Y8
    - Recruiting
    - Toronto Research Centre Inc
  - Toronto, Ontario, Canada, M4C 1L1
    - Recruiting
    - FACET Dermatology
  - Toronto, Ontario, Canada, M2N 3A6
    - Recruiting
    - North York Research Incorporated
  - Waterloo, Ontario, Canada, N2J 1C4
    - Recruiting
    - Alliance Clinical Trials
  - Windsor, Ontario, Canada, N8T 1E6
    - Recruiting
    - XLR8 Medical Research, Incorporated
- Quebec
  - Montreal, Quebec, Canada, H2X 2V1
    - Recruiting
    - Innovaderm Research Inc
  - Montreal, Quebec, Canada, H1Y 3L1
    - Recruiting
    - Clinique de Dermatologie Rosemont
  - Quebec City, Quebec, Canada, G1W 4R4
    - Recruiting
    - Clinique Medicale Saint Louis
- Saskatchewan
  - Saskatoon, Saskatchewan, Canada, S7K 2C1
    - Recruiting
    - Skinsense Medical Research
China
- - Beijing, China, 100044
    - Recruiting
    - Peking University Peoples Hospital
Croatia
- - Ivanic-Grad, Croatia, 10310
    - Recruiting
    - Special Hospital for Medical Rehabilitation Naftalan
Czechia
- - Kutna Hora, Czechia, 284 01
    - Recruiting
    - Kozni ambulance Kutna Hora sro
  - Nachod, Czechia, 547 01
    - Recruiting
    - Dermamedica, sro
  - Novy Jicin, Czechia, 741 01
    - Recruiting
    - Nemocnice Novy Jicin as
  - Ostrava, Czechia, 702 00
    - Recruiting
    - CCR Ostrava sro
  - Pardubice, Czechia, 530 02
    - Recruiting
    - Pratia Pardubice as
  - Plzen, Czechia, 305 99
    - Recruiting
    - Fakultni nemocnice Plzen
  - Praha, Czechia, 120 00
    - Recruiting
    - Dermamedest sro
  - Praha 10, Czechia, 100 00
    - Recruiting
    - Clintrial sro
  - Praha 3, Czechia, 130 00
    - Recruiting
    - Pratia Prague sro
  - Praha 5, Czechia, 150 00
    - Recruiting
    - Praglandia sro
  - Praha 6, Czechia, 106 00
    - Recruiting
    - Kozni ambulance Fialova sro
  - Praha 8, Czechia, 180 81
    - Recruiting
    - Fakultni nemocnice Bulovka
  - Svitavy, Czechia, 568 02
    - Recruiting
    - Dermatologicka ambulance MUDr Petr Trestik
  - Usti nad Labem, Czechia, 401 13
    - Recruiting
    - Krajska zdravotni as - Masarykova nemocnice Usti nad Labem oz
Denmark
- - Hellerup, Denmark, 2900
    - Recruiting
    - Gentofte Hospital
Estonia
- - Tallinn, Estonia, 13419
    - Recruiting
    - North Estonia Medical Centre
France
- - Antony, France, 92160
    - Recruiting
    - Hopital Prive d Antony
  - Bezannes, France, 51430
    - Recruiting
    - Polyclinique de Courlancy
  - Lille, France, 59037
    - Recruiting
    - Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez
  - Lorient Cedex, France, 56322
    - Recruiting
    - Centre Hospitalier de Bretagne Sud - Hopital du Scorff
  - Martigues, France, 13500
    - Recruiting
    - Cabinet du Docteur Ruer-Mulard Mireille
  - Nice, France, 06202
    - Recruiting
    - Centre Hospitalier Universitaire Archet 2
  - Rouen Cedex, France, 76031
    - Recruiting
    - Centre Hospitalier Universitaire de Rouen - Hôpital Charles Nicolle
Germany
- - Bad Bentheim, Germany, 48455
    - Recruiting
    - Fachklinik Bad Bentheim
  - Berlin, Germany, 10117
    - Recruiting
    - Charite - Universitaetsmedizin Berlin, Campus Mitte
  - Blankenfelde-Mahlow, Germany, 15831
    - Recruiting
    - Dermatologische Gemeinschaftspraxis-Mahlow
  - Bochum, Germany, 44793
    - Recruiting
    - Hautarztpraxis Dr Niesmann und Dr Othlinghaus
  - Darmstadt, Germany, 64283
    - Recruiting
    - Rosenpark Research GmbH
  - Dresden, Germany, 01307
    - Recruiting
    - Universitaetsklinikum Dresden
  - Goettingen, Germany, 37075
    - Recruiting
    - Universitaetsmedizin Goettingen - Georg-August-Universitaet
  - Heidelberg, Germany, 69120
    - Recruiting
    - Universitaetsklinikum Heidelberg
  - Kiel, Germany, 24105
    - Recruiting
    - Universitaetsklinikum Schleswig-Holstein
  - Leipzig, Germany, 04103
    - Recruiting
    - Velocity Clinical Research
  - Memmingen, Germany, 87700
    - Recruiting
    - Beldio Research Gmbh
  - Merzing, Germany, 66663
    - Recruiting
    - Hautmedizin Saar
  - Muenster, Germany, 48149
    - Recruiting
    - Universitaetsklinikum Muenster
  - Osnabrueck, Germany, 49074
    - Recruiting
    - KliFOs Klinische Forschung Osnabrueck
  - Remscheid, Germany, 42897
    - Recruiting
    - Hautarztpraxis Mortazawi
  - Stuttgart, Germany, 70178
    - Recruiting
    - Hautarztpraxis Dres Leitz und Kollegen
  - Tuebingen, Germany, 72076
    - Recruiting
    - Universitaetsklinikum Tuebingen
  - Wuppertal, Germany, 42283
    - Recruiting
    - Helios Klinikum Wuppertal
  - Wuppertal, Germany, 42287
    - Recruiting
    - CentroDerm GmbH
Greece
- - Athens, Greece, 16121
    - Recruiting
    - Andreas Syngros Hospital Of Venereal And Dermatological Diseases
  - Nea Ionia, Greece, 14233
    - Recruiting
    - General Hospital Of Nea Ionia Konstantopouleio Patision
Hungary
- - Bekescsaba, Hungary, 5600
    - Recruiting
    - Trial Pharma Kft
  - Budapest, Hungary, 1036
    - Recruiting
    - Obudai Egeszsegugyi Centrum Kft
  - Budapest, Hungary, 1027
    - Recruiting
    - Csalogany Orvosi Kozpont
  - Debrecen, Hungary, 4032
    - Recruiting
    - Debreceni Egyetem Klinikai Kozpont
  - Gyongyos, Hungary, 3200
    - Recruiting
    - Bugát Pál Kórház
  - Kaposvar, Hungary, 7400
    - Recruiting
    - Somogy Varmegyei Kaposi Mor Oktato Korhaz
  - Oroshaza, Hungary, 5900
    - Recruiting
    - DermaMed Research Kft
  - Szolnok, Hungary, 5000
    - Recruiting
    - Allergo-Derm Bakos Kft
  - Veszprem, Hungary, 8200
    - Recruiting
    - Medmare Bt
  - Zalaegerszeg, Hungary, 8900
    - Recruiting
    - Obudai Egeszsegugyi Centrum Kft
Italy
- - Rozzano MI, Italy, 20089
    - Recruiting
    - Irccs Istituto Clinico Humanitas
Japan
- Aichi
  - Nagoya-shi, Aichi, Japan, 457-8510
    - Recruiting
    - Japan Community Healthcare Organization Chukyo Hospital
  - Nagoya-shi, Aichi, Japan, 467-8602
    - Recruiting
    - Nagoya City University Hospital
  - Nagoya-shi, Aichi, Japan, 454-0803
    - Recruiting
    - Fukui Dermatology Clinic
  - Nagoya-shi, Aichi, Japan, 464-0821
    - Recruiting
    - Central Clinic
- Chiba
  - Matsudo-shi, Chiba, Japan, 271-0092
    - Recruiting
    - Miyata Dermatology Clinic
  - Narita-shi, Chiba, Japan, 286-8520
    - Recruiting
    - International University of Health and Welfare Narita Hospital
- Fukuoka
  - Fukuoka-shi, Fukuoka, Japan, 814-0180
    - Recruiting
    - Fukuoka University Hospital
  - Fukuoka-shi, Fukuoka, Japan, 819-0373
    - Recruiting
    - Matsuo Clinic
  - Fukuoka-shi, Fukuoka, Japan, 812-0013
    - Recruiting
    - Ekihigashi Dermatology Allergy Clinic
- Fukushima
  - Fukushima-shi, Fukushima, Japan, 960-1295
    - Recruiting
    - Fukushima Medical University Hospital
- Hokkaido
  - Asahikawa-shi, Hokkaido, Japan, 070-8610
    - Recruiting
    - Asahikawa City Hospital
  - Obihiro-shi, Hokkaido, Japan, 080-0013
    - Recruiting
    - Takagi Dermatological Clinic Branch
  - Sapporo-shi, Hokkaido, Japan, 060-0063
    - Recruiting
    - Medical Corporation Kojinkai Sapporo Skin Clinic
- Hyogo
  - Kobe-shi, Hyogo, Japan, 650-0017
    - Recruiting
    - Kobe University Hospital
- Ibaraki
  - Inashiki-gun, Ibaraki, Japan, 300-0395
    - Recruiting
    - Tokyo Medical University Ibaraki Medical Center
- Ishikawa
  - Nonoichi-shi, Ishikawa, Japan, 921-8801
    - Recruiting
    - Kaji Dermatology Clinic
- Iwate
  - Morioka-shi, Iwate, Japan, 020-8505
    - Recruiting
    - Iwate Medical University Uchimaru Medical Center
- Kagawa
  - Marugame-shi, Kagawa, Japan, 763-0074
    - Recruiting
    - Takeoka Dermatology Clinic
- Kagoshima
  - Kagoshima-shi, Kagoshima, Japan, 890-0063
    - Recruiting
    - Katahira Dermatology Urology Clinic
- Kanagawa
  - Kawasaki-shi, Kanagawa, Japan, 216-8511
    - Recruiting
    - St Marianna University Hospital
  - Kawasaki-shi, Kanagawa, Japan, 211-0063
    - Recruiting
    - Kosugi Dermatology Clinic
  - Kawasaki-shi, Kanagawa, Japan, 211-8533
    - Recruiting
    - Nippon Medical School Musashikosugi Hospital
  - Sagamihara-shi, Kanagawa, Japan, 252-0392
    - Recruiting
    - National Hospital Organization Sagamihara National Hospital
  - Yokohama-shi, Kanagawa, Japan, 221-0825
    - Recruiting
    - Nomura Dermatology Clinic
  - Yokohama-shi, Kanagawa, Japan, 224-8503
    - Recruiting
    - Showa University Northern Yokohama Hospital
- Kumamoto
  - Kumamoto-shi, Kumamoto, Japan, 862-0950
    - Recruiting
    - Suizenji Dermatology Clinic
  - Kumamoto-shi, Kumamoto, Japan, 860-0066
    - Recruiting
    - Jouzan Hihuka Hinyoukika Clinic
- Kyoto
  - Kyoto-shi, Kyoto, Japan, 602-8566
    - Recruiting
    - University Hospital Kyoto Prefectural University of Medicine
  - Kyoto-shi, Kyoto, Japan, 607-8062
    - Recruiting
    - Rakuwakai Otowa Hospital
- Nagasaki
  - Nagasaki-shi, Nagasaki, Japan, 852-8501
    - Recruiting
    - Nagasaki University Hospital
- Osaka
  - Habikino-shi, Osaka, Japan, 583-8588
    - Recruiting
    - Osaka Habikino Medical Center
  - Izumiotsu-shi, Osaka, Japan, 595-0025
    - Recruiting
    - Mochida Dermatology Clinic
  - Neyagawa-shi, Osaka, Japan, 572-0838
    - Recruiting
    - Yoshioka Dermatology Clinic
  - Sakai-shi, Osaka, Japan, 593-8324
    - Recruiting
    - Dermatology and Ophthalmology Kume Clinic
- Shizuoka
  - Hamamatsu-shi, Shizuoka, Japan, 431-3192
    - Recruiting
    - Hamamatsu University Hospital
  - Hamamatsu-shi, Shizuoka, Japan, 430-0929
    - Recruiting
    - JA Shizuoka Kohseiren Enshu Hospital
- Tochigi
  - Shimotsuga-gun, Tochigi, Japan, 321-0293
    - Recruiting
    - Dokkyo Medical University Hospital
- Tokyo
  - Adachi-ku, Tokyo, Japan, 120-0034
    - Recruiting
    - Mildix Skin Clinic
  - Itabashi-ku, Tokyo, Japan, 173-8606
    - Recruiting
    - Teikyo University Hospital
  - Itabashi-ku, Tokyo, Japan, 173-8610
    - Recruiting
    - Nihon University Itabashi Hospital
  - Minato-ku, Tokyo, Japan, 108-0014
    - Recruiting
    - Mita Dermatology Clinic
  - Setagaya-ku, Tokyo, Japan, 158-0097
    - Recruiting
    - Naoko Dermatology Clinic
  - Shinagawa-ku, Tokyo, Japan, 142-8666
    - Recruiting
    - Showa University Hospital
  - Shinagawa-ku, Tokyo, Japan, 141-8625
    - Recruiting
    - NTT Medical Center Tokyo
  - Shinjuku-ku, Tokyo, Japan, 161-8521
    - Recruiting
    - Seibo International Catholic Hospital
  - Shinjuku-ku, Tokyo, Japan, 169-0075
    - Recruiting
    - Yamate Dermatology Clinic
  - Toshima-ku, Tokyo, Japan, 170-0002
    - Recruiting
    - Sugamo Kobayashi Derma Clinic
- Toyama
  - Takaoka-shi, Toyama, Japan, 933-0871
    - Recruiting
    - Shirasaki Dermatology Clinic
Korea, Republic of
- - Ansansi, Gyeonggido, Korea, Republic of, 15355
    - Recruiting
    - Korea University Ansan Hospital
  - Incheon, Korea, Republic of, 22332
    - Recruiting
    - Inha University Hospital
  - Incheon, Korea, Republic of, 21431
    - Recruiting
    - The Catholic University of Korea Incheon St Marys Hospital
  - Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
    - Recruiting
    - Seoul National University Bundang Hospital
  - Seoul, Korea, Republic of, 03080
    - Recruiting
    - Seoul National University Hospital
  - Seoul, Korea, Republic of, 05505
    - Recruiting
    - Asan Medical Center
  - Seoul, Korea, Republic of, 06973
    - Recruiting
    - Chung-ang University Hospital
  - Seoul, Korea, Republic of, 03722
    - Recruiting
    - Severance Hospital, Yonsei University Health System
  - Seoul, Korea, Republic of, 02841
    - Recruiting
    - Korea University Anam Hospital
  - Seoul, Korea, Republic of, 05278
    - Recruiting
    - Kyung Hee University Hospital at Gangdong
  - Seoul, Korea, Republic of, 05030
    - Recruiting
    - Konkuk University Medical Center
  - Seoul, Korea, Republic of, 06591
    - Recruiting
    - The Catholic University of Korea Seoul St Marys Hospital
  - Seoul, Korea, Republic of, 07804
    - Recruiting
    - Ewha Womans University Seoul Hospital
  - Seoul, Korea, Republic of, 07441
    - Recruiting
    - Hallym University Kangnam Sacred Heart Hospital
  - Seoul, Korea, Republic of, 04564
    - Recruiting
    - National Medical Center
  - Suwon-si, Gyeonggi-do, Korea, Republic of, 16499
    - Recruiting
    - Ajou University Hospital
Latvia
- - Riga, Latvia, 1003
    - Recruiting
    - Outpatient clinic Veselibas Centrs 4
  - Riga, Latvia, LV-1013
    - Recruiting
    - Outpatient clinic Veselibascentrs 4
  - Talsi, Latvia, 3201
    - Recruiting
    - Smite Aija practice in dermatology and venerology
Malaysia
- Perak
  - Ipoh, Perak, Malaysia, 30450
    - Recruiting
    - Hospital Raja Permaisuri Bainun
- Pinang
  - Georgetown, Pinang, Malaysia, 10990
    - Recruiting
    - Hospital Pulau Pinang
- Wilayah Persekutuan
  - Kuala Lumpur, Wilayah Persekutuan, Malaysia, 59100
    - Recruiting
    - University Malaya Medical Centre
Netherlands
- - Bergen op Zoom, Netherlands, 4624 VT
    - Recruiting
    - Bravis Ziekenhuis
  - Utrecht, Netherlands, 3584 CX
    - Recruiting
    - Universitair Medisch Centrum Utrecht
Poland
- - Chorzow, Poland, 41-500
    - Recruiting
    - Dermapolis Medical Dermatology Center dr n med Edyta Gebska
  - Gdansk, Poland, 80-280
    - Recruiting
    - AKK Medical Spolka z ograniczona odpowiedzialnoscia Centrum Medyczne Tu sie leczy
  - Katowice, Poland, 40-600
    - Recruiting
    - GynCentrum Spzoo NZOZ Holsamed - Oddzial Libero
  - Lodz, Poland, 90-349
    - Recruiting
    - AppleTreeClinics Network Spzoo
  - Lodz, Poland, 90-752
    - Recruiting
    - Ip Clinic Sp zoo
  - Lublin, Poland, 20-078
    - Recruiting
    - Clinical Best Solutions Sp zoo Spolka Komandytowa
  - Lublin, Poland, 20-080
    - Recruiting
    - Centrum Zdrowia i Urody Maxxmed
  - Malbork, Poland, 82-200
    - Recruiting
    - Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Spzoo
  - Nowa Sol, Poland, 67-100
    - Recruiting
    - Twoja przychodnia Ncm
  - Poznan, Poland, 61-293
    - Recruiting
    - Twoja przychodnia Pcm
  - Tarnow, Poland, 33-100
    - Recruiting
    - Alergo-Med Specjalistyczna Przychodnia Lekarska Spzoo
  - Warszawa, Poland, 02-962
    - Recruiting
    - Royalderm Agnieszka Nawrocka
  - Wroclaw, Poland, 51-503
    - Recruiting
    - DermMedica Spzoo Centrum Columbus
  - Wroclaw, Poland, 50-450
    - Recruiting
    - Dermatologiczna Praktyka Lekarska Michal Torz Dermaceum Centrum Badan Klinicznych
Portugal
- - Almada, Portugal, 2801-951
    - Recruiting
    - Hospital Garcia de Orta, EPE
  - Coimbra, Portugal, 3000-075
    - Recruiting
    - Centro Hospitalar e Universitario de Coimbra, EPE
  - Lisboa, Portugal, 1998-018
    - Recruiting
    - Hospital Cuf Descobertas
  - Porto, Portugal, 4099-001
    - Recruiting
    - Centro Hospitalar Universitario do Porto, EPE - Hospital de Santo Antonio
Singapore
- - Singapore, Singapore, 308205
    - Recruiting
    - National Skin Centre
Slovakia
- - Banska Bystrica, Slovakia, 975 17
    - Recruiting
    - Fakultna Nemocnica s poliklinikou F D Roosevelta Banska Bystrica
  - Bardejov, Slovakia, 085 01
    - Recruiting
    - Maxderm, sro
  - Bratislava, Slovakia, 851 01
    - Recruiting
    - Derma therapy, spol s ro
  - Bratislava, Slovakia, 813 69
    - Recruiting
    - Univerzitna nemocnica Bratislava - Nemocnica Stare Mesto
  - Svidnik, Slovakia, 089 01
    - Recruiting
    - Sanare spol sro
  - Topolcany, Slovakia, 955 01
    - Recruiting
    - Kaderma Majtan, sro
Slovenia
- - Maribor, Slovenia, 2000
    - Recruiting
    - Univerzitetni Klinicni Center Maribor
South Africa
- KwaZulu-Natal
  - Westville, Durban, KwaZulu-Natal, South Africa, 3630
    - Recruiting
    - Hiway Medical Centre
Spain
- - Madrid, Spain, 28031
    - Recruiting
    - Hospital Universitario Infanta Leonor
  - Madrid, Spain, 28034
    - Recruiting
    - Hospital Universitario Ramon Y Cajal
  - Madrid, Spain, 28046
    - Recruiting
    - Hospital Universitario La Paz
  - Madrid, Spain, 28006
    - Recruiting
    - Hospital Universitario de La Princesa
- Andalucía
  - Cordoba, Andalucía, Spain, 14004
    - Recruiting
    - Hospital Universitario Reina Sofia
  - Sevilla, Andalucía, Spain, 41009
    - Recruiting
    - Hospital Universitario Virgen Macarena
- Canarias
  - Las Palmas de Gran Canaria, Canarias, Spain, 35010
    - Recruiting
    - Hospital Universitario de Gran Canaria Doctor Negrin
- Cataluña
  - Badalona, Cataluña, Spain, 08916
    - Recruiting
    - Hospital Universitari Germans Trias i Pujol
- Comunidad Valenciana
  - Alicante, Comunidad Valenciana, Spain, 03010
    - Recruiting
    - Hospital General Universitario de Alicante
  - Manises, Comunidad Valenciana, Spain, 46940
    - Recruiting
    - Hospital de Manises
  - Valencia, Comunidad Valenciana, Spain, 46015
    - Recruiting
    - Hospital Arnau de Vilanova de Valencia
- Galicia
  - Santiago de Compostela, Galicia, Spain, 15706
    - Recruiting
    - Hospital Clinico Universitario de Santiago
- Navarra
  - Pamplona, Navarra, Spain, 31008
    - Recruiting
    - Clinica Universidad de Navarra
- País Vasco
  - Bilbao, País Vasco, Spain, 48013
    - Recruiting
    - Hospital Universitario Basurto
Switzerland
- - Bern, Switzerland, 3010
    - Recruiting
    - Inselspital Bern
Taiwan
- - Tainan, Taiwan, 70403
    - Recruiting
    - National Cheng Kung University Hospital
  - Taipei, Taiwan, 10002
    - Recruiting
    - National Taiwan University Hospital
Turkey
- - Ankara, Turkey, 06800
    - Recruiting
    - Ankara Bilkent Sehir Hastanesi
  - Gaziantep, Turkey, 27310
    - Recruiting
    - Gaziantep Universitesi Tip Fakultesi Hastanesi
  - Istanbul, Turkey, 34662
    - Recruiting
    - Acibadem Altunizade Hastanesi
  - Kayseri, Turkey, 38030
    - Recruiting
    - Erciyes Universitesi Tip Fakultesi Hastanesi
  - Samsun, Turkey, 55200
    - Recruiting
    - Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
United States
- Alabama
  - Birmingham, Alabama, United States, 35244
    - Recruiting
    - Cahaba Dermatology and Skin Health Center
- Arizona
  - Phoenix, Arizona, United States, 85006
    - Recruiting
    - Medical Dermatology Specialists
  - Phoenix, Arizona, United States, 85032
    - Recruiting
    - Alliance Dermatology and Mohs Center
  - Scottsdale, Arizona, United States, 85255
    - Recruiting
    - Affiliated Dermatology
- Arkansas
  - Hot Springs, Arkansas, United States, 71913
    - Recruiting
    - Burke Pharmaceutical Research
  - North Little Rock, Arkansas, United States, 72117
    - Recruiting
    - Arkansas Research Trials, LLC
- California
  - Bakersfield, California, United States, 93301
    - Recruiting
    - Kern Research Inc
  - Canoga Park, California, United States, 91303
    - Recruiting
    - Hope Clinical Research LLC
  - Dublin, California, United States, 94568
    - Recruiting
    - West Coast Research LLC
  - Encinitas, California, United States, 92024
    - Recruiting
    - California Dermatology and Clinical Research Institute
  - Fountain Valley, California, United States, 92708
    - Recruiting
    - First OC Dermatology
  - Lancaster, California, United States, 93534
    - Recruiting
    - Antelope Valley Clinical Trials
  - Long Beach, California, United States, 90805
    - Recruiting
    - Long Beach Research Institute
  - Los Angeles, California, United States, 90045
    - Recruiting
    - Dermatology Research Associates
  - Sacramento, California, United States, 95815
    - Recruiting
    - Integrative Skin Science and Research
  - Sacramento, California, United States, 95816
    - Recruiting
    - University of California at Davis Medical Center
  - San Diego, California, United States, 92120
    - Recruiting
    - Acclaim Clinical Research
  - Santa Ana, California, United States, 92705
    - Recruiting
    - Wolverine Clinical Trials
  - Santa Monica, California, United States, 90404
    - Recruiting
    - Clinical Science Institute
- Colorado
  - Centennial, Colorado, United States, 80112
    - Recruiting
    - IMMUNOe Research Centers
- District of Columbia
  - Washington, District of Columbia, United States, 20016
    - Recruiting
    - Foxhall Research Center
- Florida
  - Boca Raton, Florida, United States, 33486
    - Recruiting
    - Skin Care Research Incorporated
  - Cape Coral, Florida, United States, 33991
    - Recruiting
    - Renaissance Research and Medical Group
  - Doral, Florida, United States, 33172
    - Recruiting
    - Saint Jude Clinical Research
  - Hialeah, Florida, United States, 33012
    - Recruiting
    - Direct Helpers Research Center
  - Miami, Florida, United States, 33175
    - Recruiting
    - Healthy Life Research
  - Miami, Florida, United States, 33176
    - Recruiting
    - Anchor Medical Research
  - Miami Lakes, Florida, United States, 33014
    - Recruiting
    - Savin Medical Group LLC
  - Palmetto Bay, Florida, United States, 33157
    - Recruiting
    - Innovation Medical Research Center Inc
  - Tampa, Florida, United States, 33615
    - Recruiting
    - Olympian Clinical Research - Tampa
- Georgia
  - Alpharetta, Georgia, United States, 30022
    - Recruiting
    - Atlanta Dermatology, Vein and Research Center, PC
  - Sandy Springs, Georgia, United States, 30328
    - Recruiting
    - Advanced Medical Research Pc
- Idaho
  - Boise, Idaho, United States, 83706
    - Recruiting
    - Treasure Valley Medical Research
- Illinois
  - Chicago, Illinois, United States, 60602
    - Recruiting
    - DeNova Research
  - Normal, Illinois, United States, 61761
    - Recruiting
    - Sneeze, Wheeze, and Itch Associates, LLC
- Indiana
  - Indianapolis, Indiana, United States, 46250
    - Recruiting
    - Dawes Fretzin Clinical Research Group, LLC
  - Plainfield, Indiana, United States, 46168
    - Recruiting
    - The Indiana Clinical Trials Center PC
  - West Lafayette, Indiana, United States, 47906
    - Recruiting
    - Options Research Group LLC
- Kansas
  - Leawood, Kansas, United States, 66211
    - Recruiting
    - Dermatology and Skin Cancer Center Leawood
- Kentucky
  - Louisville, Kentucky, United States, 40241
    - Recruiting
    - Ds Research
  - Murray, Kentucky, United States, 42071
    - Recruiting
    - Kentucky Advanced Medical Research LLC
- Maryland
  - Towson, Maryland, United States, 21204
    - Recruiting
    - Continental Clinical Solutions, LLC
- Massachusetts
  - Brighton, Massachusetts, United States, 02135
    - Recruiting
    - MetroBoston Clinical Partners
- Michigan
  - Ann Arbor, Michigan, United States, 48109
    - Recruiting
    - University of Michigan Medical Center
  - Detroit, Michigan, United States, 48202
    - Recruiting
    - Henry Ford Health System
  - Flint, Michigan, United States, 48532
    - Recruiting
    - Onyx Clinical Research
  - Troy, Michigan, United States, 48084
    - Recruiting
    - Revival Research Institute LLC
  - Troy, Michigan, United States, 48084
    - Recruiting
    - Somerset Skin Centre
- Missouri
  - Lee's Summit, Missouri, United States, 64064
    - Recruiting
    - Dermatology and Skin Cancer Center of Lees Summit
- Nebraska
  - Lincoln, Nebraska, United States, 68505
    - Recruiting
    - Somnos Clinical Research
  - Omaha, Nebraska, United States, 68144
    - Recruiting
    - Skin Specialists PC
- Nevada
  - Las Vegas, Nevada, United States, 89109
    - Recruiting
    - Excel Clinical Research
  - Las Vegas, Nevada, United States, 89106
    - Recruiting
    - Jubilee Clinical Research Inc
  - North Las Vegas, Nevada, United States, 89030
    - Recruiting
    - Las Vegas Clinical Trials
  - Reno, Nevada, United States, 89509
    - Recruiting
    - Skin Cancer and Dermatology Institute
- New York
  - New York, New York, United States, 10029
    - Recruiting
    - Icahn School of Medicine at Mount Sinai
  - New York, New York, United States, 10128
    - Recruiting
    - OptiSkin Medical
- North Carolina
  - Charlotte, North Carolina, United States, 28277
    - Recruiting
    - Dermatology Specialists of Charlotte
  - Wilmington, North Carolina, United States, 28405
    - Recruiting
    - Wilmington Dermatology Center
  - Wilmington, North Carolina, United States, 28411
    - Recruiting
    - Accellacare of Wilmington
  - Winston-Salem, North Carolina, United States, 27103
    - Recruiting
    - The Skin Surgery Center
- Ohio
  - Bexley, Ohio, United States, 43209
    - Recruiting
    - Bexley Dermatology Research
  - Gahanna, Ohio, United States, 43230
    - Recruiting
    - The Ohio State University Dermatology East
  - Mayfield Heights, Ohio, United States, 44124
    - Recruiting
    - Apex Clinical Research Center LLC
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73118
    - Recruiting
    - Unity Clinical Research
  - Tulsa, Oklahoma, United States, 74132
    - Recruiting
    - Dermatology Research Center of Oklahoma, PLLC
  - Tulsa, Oklahoma, United States, 74137
    - Recruiting
    - Essential Medical Research LLC
- Oregon
  - Medford, Oregon, United States, 97504
    - Recruiting
    - Velocity Clinical Research Inc
  - Portland, Oregon, United States, 97201
    - Recruiting
    - Oregon Medical Research Center
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19103
    - Recruiting
    - Paddington Testing Company Inc
  - Pittsburgh, Pennsylvania, United States, 15213
    - Recruiting
    - University of Pittsburgh Medical Center
  - Sugarloaf, Pennsylvania, United States, 18249
    - Recruiting
    - DermDox Dermatology, LLC
- South Dakota
  - Rapid City, South Dakota, United States, 57702
    - Recruiting
    - Health Concepts
- Tennessee
  - Hermitage, Tennessee, United States, 37076
    - Recruiting
    - Cumberland Skin Center
- Texas
  - Austin, Texas, United States, 78759
    - Recruiting
    - US Dermatology Partners Jollyville
  - Bellaire, Texas, United States, 77401
    - Recruiting
    - Bellaire Dermatology Associates
  - Cedar Park, Texas, United States, 78613
    - Recruiting
    - US Dermatology Partners Cedar Park
  - Dallas, Texas, United States, 75230
    - Recruiting
    - Dermatology Treatment and Research Center PA
  - Dallas, Texas, United States, 75230
    - Recruiting
    - Zenos Clinical Research, LLC
  - El Paso, Texas, United States, 79925
    - Recruiting
    - Newco 3A Research LLC
  - Mesquite, Texas, United States, 75149
    - Recruiting
    - sms Clinical Research Limited Liability Company
  - Plano, Texas, United States, 75025
    - Recruiting
    - Texas Dermatology Research Center
  - San Antonio, Texas, United States, 78218
    - Recruiting
    - Texas Dermatology and Laser Specialists
- Virginia
  - Lynchburg, Virginia, United States, 24501
    - Recruiting
    - Education and Research Foundation Inc
  - Norfolk, Virginia, United States, 23502
    - Recruiting
    - Virginia Dermatology and Skin Cancer Center
- Washington
  - Spokane, Washington, United States, 99202
    - Recruiting
    - Multicare Institute for Research and Innovation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Completion of an end of treatment duration visit (Week 24 or Week 52 visit for adult or adolescent studies, respectively) in a rocatinlimab parent study (ROCKET-IGNITE, ROCKET-HORIZON, ROCKET-SHUTTLE, ROCKET-ASTRO, ROCKET-ORBIT, OR ROCKET-VOYAGER) within the past 28 days.

Exclusion Criteria:

Permanent investigational product discontinuation due to safety-related reasons, protocol-defined stopping rules or conditions/reasons unrelated to efficacy during the rocatinlimab parent study (ROCKET-IGNITE, ROCKET-HORIZON, ROCKET-SHUTTLE, ROCKET-ASTRO, ROCKET-ORBIT, OR ROCKET-VOYAGER), or at the time of Screening or Day 1.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ARM B: Dose 2 to Dose 2 Participants from parent Rocatinlimab studies ROCKET-Ignite, ROCKET-SHUTTLE, or ROCKET-ASTRO who received Dose 2 will be randomized or assigned to receive Dose 2 Q4W or Q8W.	Drug: Rocatinlimab Subcutaneous (SC) injection Other Names: AMG 451 KHK4083
Placebo Comparator: ARM C: Dose 1 or Dose 2 to Placebo Participants from parent Rocatinlimab studies ROCKET-Ignite or ROCKET-Horizon who received Dose 1 will be randomized to receive placebo Q4W. Participants from parent Rocatinlimab study ROCKET-Ignite who received Dose 2 will be randomized to receive placebo Q4W.	Other: Placebo SC injection
Experimental: ARM A: Dose 1 to Dose 1 Participants from parent Rocatinlimab studies ROCKET-Ignite, ROCKET-Horizon, ROCKET-SHUTTLE, or ROCKET-ASTRO who received Dose 1 will be randomized or assigned to receive Dose 1 Every 4 Weeks (Q4W) or Every 8 Weeks (Q8W). Participants from parent Rocatinlimab study ROCKET-VOYAGER who received Dose 1 will be assigned to receive Dose 1 Q4W.	Drug: Rocatinlimab Subcutaneous (SC) injection Other Names: AMG 451 KHK4083
Placebo Comparator: ARM D: Placebo to Placebo Participants from parent Rocatinlimab studies ROCKET- Ignite, ROCKET-Horizon, ROCKET-SHUTTLE, ROCKET-ASTRO, or ROCKET-VOYAGER who received placebo will be randomized or assigned to receive placebo Q4W.	Other: Placebo SC injection
Experimental: ARM E: Dose 1, Dose 2, Placebo, or Open-label (OL) to OL Dose 1 Participants from parent Rocatinlimab studies ROCKET- Ignite, ROCKET-Horizon, ROCKET- SHUTTLE, ROCKET-ASTRO, or ROCKET-VOYAGER who received Dose 1, Dose 2, or placebo will be assigned to receive OL Rocatinlimab Dose 1 Q4W. Participants who received OL in parent Rocatinlimab study ROCKET- ASTRO will continue to receive OL Rocatinlimab Dose 1 Q4W. All participants from parent Rocatinlimab study ROCKET-Orbit will be assigned to receive OL Rocatinlimab Dose 1 Q4W.	Drug: Rocatinlimab Subcutaneous (SC) injection Other Names: AMG 451 KHK4083

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Treatment-emergent Adverse Events Time Frame: Up to 116 weeks	Up to 116 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maintaining EASI 75 Response Among Participants Achieving EASI 75 Response at Day 1 Time Frame: Up to 104 weeks		Up to 104 weeks
Percent Change From Parent Study Baseline in EASI Score Among Participants Achieving EASI 75 Response at Day 1 Time Frame: Up to 104 weeks		Up to 104 weeks
Maintaining ≥ 4-point Reduction From Parent Study Baseline in Weekly Average of Daily Worst Pruritus Numerical Rating Scale (NRS) Score Time Frame: Up to 104 weeks	Among Participants Achieving ≥ 4-point Reduction From Parent Study Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Day 1	Up to 104 weeks
Maintaining Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD™) 0/1 Response Among Participants Achieving vIGA-AD™ 0/1 Response at Day 1 Time Frame: Up to 104 weeks		Up to 104 weeks
Maintaining vIGA-AD™ 1 Response with Presence of Only Barely Perceptible Erythema or vIGA-AD™ 0 Response Among Participants Achieving vIGA-AD™ 1 Response With Presence of Only Barely Perceptible Erythema or vIGA-AD™ 0 Response at Day 1 Time Frame: Up to 104 weeks		Up to 104 weeks
Maintaining vIGA-AD™ 0/1 Response and EASI 75 Response Among Participants Achieving vIGA-AD™ 0/1 Response and EASI 75 Response at Day 1 Time Frame: Up to 104 weeks		Up to 104 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Investigators

Study Director: MD, Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

AmgenTrials clinical trials website

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2023

Primary Completion (Estimated)

June 4, 2027

Study Completion (Estimated)

June 4, 2027

Study Registration Dates

First Submitted

May 22, 2023

First Submitted That Met QC Criteria

May 22, 2023

First Posted (Actual)

May 31, 2023

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 27, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

20210146
2022-501587-17 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

IPD Sharing Time Frame

Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.

IPD Sharing Access Criteria

Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

IPD Sharing Supporting Information Type

STUDY_PROTOCOL
SAP
ICF
CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Publications and helpful links

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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