Atopic DermatitisPhase 3ROCKET-ASCENDNCT05882877
A Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)
A Phase 3 study testing Rocatinlimab in people with Atopic Dermatitis, run by Amgen at 547 sites in 42 countries.
Trial summary
The primary objective of this study is to describe the long-term safety and tolerability of rocatinlimab in participants with moderate-to-severe AD. Read more about this study
- Who is it for?
- Ages 12 to 100 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Rocatinlimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,621 participants
- Where
- 547 sitesin 42 countries
- Study dates
- 31 May 2023to 1 Jul 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
- Participants from the parent study ROCKET-ORBIT must achieve an improvement in EASI score at week 52 of at least 60% compared to parent study baseline (EASI 60).
Who cannot join
- 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.
Trial locations and contacts
547 sites in 42 countries.
547 sites in 42 countries
United States136 sites
Albuquerque Clinical Trials Incorporated
Albuquerque, New Mexico, 87102
Atlanta Dermatology, Vein and Research Center, PC
Alpharetta, Georgia, 30022
University of Michigan
Ann Arbor, Michigan, 48109
US Dermatology Partners Jollyville
Austin, Texas, 78759
Kern Research Inc
Bakersfield, California, 93301
Bellaire Dermatology Associates
Bellaire, Texas, 77401
Bexley Dermatology Research
Bexley, Ohio, 43209
Cahaba Dermatology and Skin Health Center
Birmingham, Alabama, 35244
Skin Care Research Incorporated
Boca Raton, Florida, 33486
Treasure Valley Medical Research
Boise, Idaho, 83706
MetroBoston Clinical Partners
Brighton, Massachusetts, 02135
Dermatology Trial Associates
Bryant, Arkansas, 72022
Best Skin Research
Camp Hill, Pennsylvania, 17011
Hope Clinical Research LLC
Canoga Park, California, 91303
Renaissance Research and Medical Group
Cape Coral, Florida, 33991
US Dermatology Partners Cedar Park
Cedar Park, Texas, 78613
IMMUNOe Research Centers
Centennial, Colorado, 80112
Medical University of South Carolina
Charleston, South Carolina, 29425
DJL Clinical Research PLLC
Charlotte, North Carolina, 28211
Foxhall Research Center
Chevy Chase, Maryland, 20815
Institute for Asthma and Allergy
Chevy Chase, Maryland, 20815
DeNova Research
Chicago, Illinois, 60602
Bernstein Clinical Research Center LLC
Cincinnati, Ohio, 45236
DS Research
Clarksville, Indiana, 47129
Driven Research LLC
Coral Gables, Florida, 33134
Corazon United States of America, LLC doing business as Life Clinical Trials
Coral Springs, Florida, 33071
Driscoll Childrens Hospital
Corpus Christi, Texas, 78411
Alina Clinical Trials, LLC
Dallas, Texas, 75225
Dermatology Treatment and Research Center PA
Dallas, Texas, 75230
Zenos Clinical Research
Dallas, Texas, 75230
Texas Dermatology Research Center
Dallas, Texas, 75246
Henry Ford Medical Center - New Center One
Detroit, Michigan, 48202
D and H Doral Research Centers
Doral, Florida, 33122
Saint Jude Clinical Research
Doral, Florida, 33172
West Coast Research LLC
Dublin, California, 94568
Newco 3A Research LLC
El Paso, Texas, 79925
California Dermatology and Clinical Research Institute
Encinitas, California, 92024
First Georgia Physicians Group
Fayetteville, Georgia, 30214
Onyx Clinical Research
Flint, Michigan, 48532
Education and Research Foundation Inc
Forest, Virginia, 24551
First OC Dermatology
Fountain Valley, California, 92708
The Ohio State University
Gahanna, Ohio, 43230
Cumberland Skin Center
Hermitage, Tennessee, 37076
Direct Helpers Research Center
Hialeah, Florida, 33012
Global Research Solutions
Homestead, Florida, 33030
Nexus Clinical Research
Homestead, Florida, 33033
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913
Center For Clinical Studies PLLC
Houston, Texas, 77004
University of Texas Health Science Center at Houston
Houston, Texas, 77030
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250
Sante Clinical Research
Kerrville, Texas, 78028
Forest Hills Dermatology Group
Kew Gardens, New York, 11415
Antelope Valley Clinical Trials
Lancaster, California, 93534
Chemidox Clinical Trials Incorporated
Lancaster, California, 93534
Jubilee Clinical Research Inc
Las Vegas, Nevada, 89106
Excel Clinical Research
Las Vegas, Nevada, 89109
Dermatology and Skin Cancer Center Leawood
Leawood, Kansas, 66211
Dermatology and Skin Cancer Center of Lees Summit
Lee's Summit, Missouri, 64064
Somnos Clinical Research
Lincoln, Nebraska, 68505
Long Beach Research Institute
Long Beach, California, 90805
University of California Los Angeles
Los Angeles, California, 90024
Dermatology Research Associates
Los Angeles, California, 90045
Wallace Medical Group Inc
Los Angeles, California, 90056
DS Research
Louisville, Kentucky, 40241
Long and Harris Dermatology
Lubbock, Texas, 79424
Glick Skin Institute
Margate, Florida, 33063
Apex Clinical Research Center LLC
Mayfield Heights, Ohio, 44124
Velocity Clinical Research Medford
Medford, Oregon, 97504
Sms Clinical Research Limited Liability Company
Mesquite, Texas, 75149
ara Professionals Limited Liability Corporation
Miami, Florida, 33155
Gold Coast Health Research Center
Miami, Florida, 33155
Miami Clinical Research
Miami, Florida, 33155
Healthy Life Research
Miami, Florida, 33175
Anchor Medical Research
Miami, Florida, 33176
Meridian International Research
Miami Gardens, Florida, 33014
Savin Medical Group LLC
Miami Lakes, Florida, 33014
Stride Clinical Research LLC
Missouri City, Texas, 77459
Kentucky Advanced Medical Research LLC
Murray, Kentucky, 42071
Tanner Clinic
Murray, Utah, 84107
University of Utah MidValley Dermatology
Murray, Utah, 84107
Southern Indiana Clinical Trials
New Albany, Indiana, 47150
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Sadick Research Group
New York, New York, 10075
OptiSkin Medical
New York, New York, 10128
Virginia Dermatology and Skin Cancer Center
Norfolk, Virginia, 23502
Eastern Virginia Medical School
Norfolk, Virginia, 23507
Sneeze, Wheeze, and Itch Associates, LLC
Normal, Illinois, 61761
Las Vegas Clinical Trials
North Las Vegas, Nevada, 89030
Arkansas Research Trials, LLC
North Little Rock, Arkansas, 72117
Northridge Clinical Trials
Northridge, California, 91325
Unity Clinical Research
Oklahoma City, Oklahoma, 73118
University of California Irvine
Orange, California, 92868
Clinical Associates of Orlando Limited Liability Company
Orlando, Florida, 32819
Innovation Medical Research Center Inc
Palmetto Bay, Florida, 33157
Havana Research Institute Inc
Pasadena, California, 91105
Paddington Testing Company Inc
Philadelphia, Pennsylvania, 19103
Medical Dermatology Specialists
Phoenix, Arizona, 85006
Alliance Dermatology and Mohs Center
Phoenix, Arizona, 85032
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
The Indiana Clinical Trials Center PC
Plainfield, Indiana, 46168
Oregon Medical Research Center
Portland, Oregon, 97201
Oregon Dermatology and Research Center
Portland, Oregon, 97210
Health Concepts
Rapid City, South Dakota, 57702
Skin Cancer and Dermatology Institute
Reno, Nevada, 89509
Integrative Skin Science and Research
Sacramento, California, 95815
University of California at Davis Medical Center
Sacramento, California, 95816
Kaiser Permanente South Sacramento Medical Center
Sacramento, California, 95823
Texas Dermatology and Laser Specialists
San Antonio, Texas, 78218
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, 78229
Alliance Clinical Research
San Diego, California, 92120
Kaiser Permanente Medical Center - Oakland
San Francisco, California, 94118
Kaiser Permanente Medical Center - San Francisco
San Francisco, California, 94118
Advanced Medical Research PC
Sandy Springs, Georgia, 30328
Wolverine Clinical Trials
Santa Ana, California, 92706
Clinical Science Institute
Santa Monica, California, 90404
Affiliated Dermatology
Scottsdale, Arizona, 85255
Scottsdale Clinical Trials
Scottsdale, Arizona, 85260
Endeavor Health Clinical Trials Center
Skokie, Illinois, 60077
Stryde Research Epiphany Dermatology
Southlake, Texas, 76092
MultiCare Institute for Research and Innovation
Spokane, Washington, 99202
Dermatologist of Central States Clinical Research - Springfield
Springfield, Ohio, 45505
Saint Louis University
St Louis, Missouri, 63110
University of South Florida
Tampa, Florida, 33612
Olympian Clinical Research - Tampa
Tampa, Florida, 33615
Chear Center LLC
The Bronx, New York, 10455
The Woodlands Dermatology Associates
The Woodlands, Texas, 77380
Continental Clinical Solutions, LLC
Towson, Maryland, 21204
Revival Research Institute LLC
Troy, Michigan, 48084
Somerset Skin Centre
Troy, Michigan, 48084
Dermatology Research Center of Oklahoma, PLLC
Tulsa, Oklahoma, 74132
Essential Medical Research LLC
Tulsa, Oklahoma, 74145
Dundee Dermatology
West Dundee, Illinois, 60118
Options Research Group LLC
West Lafayette, Indiana, 47906
Wilmington Dermatology Center
Wilmington, North Carolina, 28405
Accellacare of Wilmington
Wilmington, North Carolina, 28411
The Skin Surgery Center for Clinical Research
Winston-Salem, North Carolina, 27103
Japan51 sites
Mildix Skin Clinic
Adachi-ku, Tokyo, 120-0034
Yoshimura Child Clinic
Akashi-shi, Hyōgo, 674-0068
Asahikawa City Hospital
Asahikawa-shi, Hokkaido, 070-8610
Ekihigashi Dermatology Allergy Clinic
Fukuoka, Fukuoka, 812-0013
Fukuoka University Hospital
Fukuoka, Fukuoka, 814-0180
Matsuo Clinic
Fukuoka, Fukuoka, 819-0373
Fukushima Medical University Hospital
Fukushima, Fukushima, 960-1295
Osaka Habikino Medical Center
Habikino-shi, Osaka, 583-8588
JA Shizuoka Kohseiren Enshu Hospital
Hamamatsu, Shizuoka, 430-0929
Hamamatsu University Hospital
Hamamatsu, Shizuoka, 431-3192
Tokyo Medical University Ibaraki Medical Center
Inashiki-gun, Ibaraki, 300-0395
Teikyo University Hospital
Itabashi-ku, Tokyo, 173-8606
Nihon University Itabashi Hospital
Itabashi-ku, Tokyo, 173-8610
Mochida Dermatology Clinic
Izumiotsu-shi, Osaka, 595-0025
Katahira Dermatology Urology Clinic
Kagoshima, Kagoshima-ken, 890-0063
Kosugi Dermatology Clinic
Kawasaki-shi, Kanagawa, 211-0063
Nippon Medical School Musashikosugi Hospital
Kawasaki-shi, Kanagawa, 211-8533
St Marianna University Hospital
Kawasaki-shi, Kanagawa, 216-8511
Kobe University Hospital
Kobe, Hyōgo, 650-0017
Jouzan Hihuka Hinyoukika Clinic
Kumamoto, Kumamoto, 860-0066
Suizenji Dermatology Clinic
Kumamoto, Kumamoto, 862-0950
University Hospital Kyoto Prefectural University of Medicine
Kyoto, Kyoto, 602-8566
Rakuwakai Otowa Hospital
Kyoto, Kyoto, 607-8062
Takeoka Dermatology Clinic
Marugame-shi, Kagawa-ken, 763-0074
Miyata Dermatology Clinic
Matsudo-shi, Chiba, 271-0092
Mita Dermatology Clinic
Minato-ku, Tokyo, 108-0014
Iwate Medical University Uchimaru Medical Center
Morioka, Iwate, 020-8505
Aichi Medical University Hospital
Nagakute-shi, Aichi-ken, 480-1195
Nagasaki University Hospital
Nagasaki, Nagasaki, 852-8501
Fukui Dermatology Clinic
Nagoya, Aichi-ken, 454-0803
Japan Community Healthcare Organization Chukyo Hospital
Nagoya, Aichi-ken, 457-8510
Central Clinic
Nagoya, Aichi-ken, 464-0821
Nagoya City University Hospital
Nagoya, Aichi-ken, 467-8602
International University of Health and Welfare Narita Hospital
Narita-shi, Chiba, 286-8520
Yoshioka Dermatology Clinic
Neyagawa, Osaka, 572-0838
Kaji Dermatology Clinic
Nonoichi-shi, Ishikawa-ken, 921-8801
Takagi Dermatological Clinic
Obihiro-shi, Hokkaido, 080-0013
National Hospital Organization Sagamihara National Hospital
Sagamihara-shi, Kanagawa, 252-0392
Dermatology and Ophthalmology Kume Clinic
Sakai-shi, Osaka, 593-8324
Medical Corporation Kojinkai Sapporo Skin Clinic
Sapporo, Hokkaido, 060-0063
Naoko Dermatology Clinic
Setagaya-ku, Tokyo, 158-0097
Dokkyo Medical University Hospital
Shimotsuga-gun, Tochigi, 321-0293
NTT Medical Center Tokyo
Shinagawa-ku, Tokyo, 141-8625
Showa Medical University Hospital
Shinagawa-ku, Tokyo, 142-8666
Seibo International Catholic Hospital
Shinjuku-ku, Tokyo, 161-8521
Yamate Dermatology Clinic
Shinjuku-ku, Tokyo, 169-0075
Shirasaki Dermatology Clinic
Takaoka-shi, Toyama, 933-0871
Sugamo Kobayashi Derma Clinic
Toshima-ku, Tokyo, 170-0002
Nomura Dermatology Clinic
Yokohama, Kanagawa, 221-0825
Showa Medical University Northern Yokohama Hospital
Yokohama, Kanagawa, 224-8503
Yokohama City Minato Red Cross Hospital
Yokohama, Kanagawa, 231-8682
Canada50 sites
CCA Medical Research Corp
Ajax, Ontario, L1S 7K8
SimcoDerm Medical and Surgical Dermatology Centre
Barrie, Ontario, L4M 7G1
Halton Pediatric Allergy
Burlington, Ontario, L7L 6W6
Dermatology Research Institute Incorporated
Calgary, Alberta, T2J 7E1
Beacon Dermatology
Calgary, Alberta, T3E 0B2
Rejuvenation Dermatology Laser Calgary North
Calgary, Alberta, T3K 6B8
SKiN Health
Coburg, Ontario, K9A 0Z4
Laser Rejuvenation Clinics Edmonton D T Incorporated
Edmonton, Alberta, T5J 3S9
Stratica Dermatology
Edmonton, Alberta, T5K 1X3
Alberta Derma Surgery Centre
Edmonton, Alberta, T6G 1C3
Vida Clinical Research
Edmonton, Alberta, T6H 4J8
Skin Physicians Dermatology
Edmonton, Alberta, T6W 4V4
Kingsway Clinical Research
Etobicoke, Ontario, M8X 1Y9
Guelph Dermatology Research
Guelph, Ontario, N1L 0B7
LEADER Research
Hamilton, Ontario, L8L 3C3
Triple A Lab
Hamilton, Ontario, L8S 1G5
Interior Dermatology Centre
Kelowna, British Columbia, V1W 4V5
Centricity Research London Victoria
London, Ontario, N6A 2C2
Lynderm Research Inc
Markham, Ontario, L3P 1X3
DermEdge Research Incorporated
Mississauga, Ontario, L4Y 4C5
Clinique de Dermatologie Rosemont
Montreal, Quebec, H1Y 3L1
Innovaderm Research Inc
Montreal, Quebec, H2X 2V1
Ryan Clinical Research Incorporated
Newmarket, Ontario, L3Y 5G8
Allergy Research Canada Incorporated
Niagara Falls, Ontario, L2H 1H5
North Bay Dermatology Centre
North Bay, Ontario, P1B 3Z7
Canadian Dermatology Centre
North York, Ontario, M3B 0A7
The Centre for Clinical Trials Inc
Oakville, Ontario, L6J 7W5
JRB Research Incorporated
Ottawa, Ontario, K1K 4L2
Dermatology Ottawa Research Centre
Ottawa, Ontario, K2C 3N2
SKiN Centre for Dermatology
Peterborough, Ontario, K9J 5K2
Recherche Clinique Sigma Incorporated
Québec, Quebec, G1G 3Y8
Centre de Recherche Dermatologique du Quebec Metropolitain
Québec, Quebec, G1V 4X7
Clinique Medicale Saint Louis
Québec, Quebec, G1W 4R4
The Centre for Dermatology
Richmond Hill, Ontario, L4B 1A5
York Dermatology Clinic and Research Centre
Richmond Hill, Ontario, L4B 1L1
Oak Ridges Aesthetics Centre
Richmond Hill, Ontario, L4E 4L6
Skinsense Medical Research
Saskatoon, Saskatchewan, S7K 2C1
Saskatoon Dermatology Centre
Saskatoon, Saskatchewan, S7T 0G3
Karma Clinical Trials
St. John's, Newfoundland and Labrador, A1A 4Y3
Doctor Chih-Ho Hong Medical Incorporated
Surrey, British Columbia, V3R 6A7
Enverus Medical Research
Surrey, British Columbia, V3V 0C6
North York Research Incorporated
Toronto, Ontario, M2N 3A6
Toronto Research Centre Inc
Toronto, Ontario, M3H 5Y8
FACET Dermatology
Toronto, Ontario, M4E 1R7
Research Toronto
Toronto, Ontario, M4W 2N4
Evidence Based Medical Educator Inc
Toronto, Ontario, M5G 1E2
Alliance Clinical Trials
Waterloo, Ontario, N2J 1C4
XLR8 Medical Research, Incorporated
Windsor, Ontario, N8T 1E6
Winnipeg Clinic Dermatology Research
Winnipeg, Manitoba, R3C 0N2
Wiseman Dermatology Research Incorporated
Winnipeg, Manitoba, R3M 3Z4
China33 sites
Peking University Peoples Hospital
Beijing, Beijing Municipality, 100044
Beijing Childrens Hospital, Capital Medical University
Beijing, Beijing Municipality, 100045
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
The First Bethune Hospital of Jilin University
Changchun, Jilin, 130021
Hunan Childrens Hospital
Changsha, Hunan, 410007
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
Chengdu Second Peoples Hospital
Chengdu, Sichuan, 610021
Childrens Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400014
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005
The First Affiliated Hospital Sun-Yat Sen University
Guangzhou, Guangdong, 510080
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, 510091
Sun Yat-sen Memorial Hospital Sun Yat-sen University
Guangzhou, Guangdong, 510120
Zhejiang Provincial Peoples Hospital
Hangzhou, Zhejiang, 310014
Affiliated Hangzhou First Peoples Hospital School of Medicine Westlake University
Hangzhou, Zhejiang, 310020
Kunming Childrens Hospital
Kunming, Yunnan, 650103
Dermatology Hospital of Jiangxi Province
Nanchang, Jiangxi, 330000
Nanyang First Peoples Hospital
Nanyang, Henan, 473002
Ningbo NO 2 Hospital
Ningbo, Zhejiang, 315010
The First Affiliation Hospital Of Ningbo University
Ningbo, Zhejiang, 315010
Sanmenxia Central Hospital
Sanmenxia, Henan, 472099
Shanghai Skin Disease Hospital
Shanghai, Shanghai Municipality, 200443
The Fist Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, 515041
The First Hospital of China Medical University
Shenyang, Liaoning, 110001
Shenzhen Childrens Hospital
Shenzhen, Guangdong, 518038
The First Hospital Of Hebei Medical University
Shijiazhuang, Hebei, 050000
Suining Central Hospital
Suining, Sichuan, 629099
Taizhou Central Hospital
Taizhou, Zhejiang, 318000
The Central Hospital of Wuhan
Wuhan, Hubei, 430014
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Wuxi Second Peoples Hospital
Wuxi, Jiangsu, 214001
Wuxi Peoples Hospital
Wuxi, Jiangsu, 241023
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004
Poland27 sites
ClinicMed Daniluk Nowak Spolka komandytowa
Bialystok, 15-879
Dermapolis Medical Dermatology Center dr n med Edyta Gebska
Chorzów, 41-500
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-214
AKK Medical Spolka z ograniczona odpowiedzialnoscia Centrum Medyczne Tu sie leczy
Gdansk, 80-280
GynCentrum Spzoo NZOZ Holsamed - Oddzial Libero
Katowice, 40-600
Centrum Medyczne Angelius Provita
Katowice, 40-611
Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy Marek Brzewski Pawel Brzewski SpCywilna
Krakow, 30-002
Diamond Clinic Spolka z Ograniczona Odpowiedzialnoscia Diamond Medical Center
Krakow, 31-559
Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna
Lodz, 90-338
AppleTreeClinics Network Spzoo
Lodz, 90-349
Ip Clinic Sp zoo
Lodz, 90-752
Amicare Spolka z ograniczona odpowiedzialnoscia Spolka Komandytowa Amicare Centrum Medyczne
Lodz, 91-495
Clinical Best Solutions Sp zoo Spolka Komandytowa
Lublin, 20-011
Centrum Zdrowia i Urody Maxxmed
Lublin, 20-080
Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Spzoo
Malbork, 82-200
Twoja przychodnia Ncm
Nowa Sól, 67-100
Twoja przychodnia Pcm
Poznan, 60-324
Centrum Zdrowia Dziecka i Rodziny Im Jana Pawla II w Sosnowcu Osrodek Badan Klinicznych
Sosnowiec, 41-200
Twoja Przychodnia Scm
Szczecin, 71-500
Alergo-Med Osrodek Badan Klinicznych sp zoo
Tarnów, 33-100
Klinika Osipowicz and Turkowski Sp zoo
Warsaw, 00-716
High Med Przychodnia Specjalistyczna
Warsaw, 01-817
Evimed sp zoo centrum medyczne evimed
Warsaw, 02-625
Klinika Ambroziak Dermatologia
Warsaw, 02-953
Royalderm Agnieszka Nawrocka
Warsaw, 02-962
DermMedica Spzoo Centrum Columbus
Wroclaw, 51-503
Dermaceum Spolka z Ograniczona Odpowiedzialnoscia Dermaceum Centrum Medyczne
Wroclaw, 53-613
Germany25 sites
Fachklinik Bad Bentheim
Bad Bentheim, 48455
Charite - Universitaetsmedizin Berlin, Campus Mitte
Berlin, 10117
Clinical Research Services Berlin GmbH
Berlin, 13672
Hautarztpraxis Dr Niesmann und Dr Othlinghaus
Bochum, 44793
Rosenpark Research GmbH
Darmstadt, 64283
Universitaetsklinikum Dresden
Dresden, 01307
Universitaetsklinikum Frankfurt
Frankfurt am Main, 60590
Universitaetsmedizin Goettingen - Georg-August-Universitaet
Göttingen, 37075
Institute for Health Services Research in Dermatology and Nursing
Hamburg, 20246
Hautaerzte Zentrum Hannover
Hanover, 30159
Universitaetsklinikum Heidelberg
Heidelberg, 69120
Universitaetsklinikum Schleswig-Holstein - Kiel
Kiel, 24105
Velocity Clinical Research
Leipzig, 04177
Dermatologische Gemeinschaftspraxis-Mahlow
Mahlow, 15831
Universitaetsmedizin Mainz
Mainz, 55101
Beldio Research GmbH
Memmingen, 87700
Hautmedizin Saar
Merzing, 66663
Klinikum rechts der Isar der TUM
München, 80802
Universitaetsklinikum Muenster
Münster, 48149
KliFOs Klinische Forschung Osnabrueck
Osnabrück, 49074
Hautarztpraxis Mortazawi
Remscheid, 42897
Hautarztpraxis Dres Leitz und Kollegen
Stuttgart, 70178
Universitaetsklinikum Tuebingen
Tübingen, 72076
Helios Klinikum Wuppertal
Wuppertal, 42283
CentroDerm GmbH
Wuppertal, 42287
Spain20 sites
Hospital General Universitario de Alicante
Alicante, Valencia, 03010
Hospital Universitari Germans Trias i Pujol
Badalona, Catalonia, 08916
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, 08025
Hospital Universitario Basurto
Bilbao, Basque Country, 48013
Hospital Universitario Reina Sofia
Córdoba, Andalusia, 14004
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Catalonia, 08907
Hospital Universitario de Gran Canaria Doctor Negrin
Las Palmas de Gran Canaria, Canary Islands, 35010
Hospital Universitario de La Princesa
Madrid, 28006
Hospital General Universitario Gregorio Maranon
Madrid, 28007
Hospital Universitario Infanta Leonor
Madrid, 28031
Hospital Universitario Ramon y Cajal
Madrid, 28034
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario La Paz
Madrid, 28046
Hospital de Manises
Manises, Valencia, 46940
Clinica Universidad de Navarra
Pamplona, Navarre, 31008
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Madrid, 28223
Hospital Clinico Universitario de Santiago
Santiago de Compostela, Galicia, 15706
Hospital Universitario Virgen Macarena
Seville, Andalusia, 41009
Hospital Arnau de Vilanova de Valencia
Valencia, Valencia, 46015
Hospital Universitario Miguel Servet
Zaragoza, 50009
Brazil19 sites
Alergoalfa Nucleo Diagnostico Tratamento e Pesquisa Clinica em Alergia
Barueri, São Paulo, 06454-010
Centro de Pesquisa Clínica da Universidade de Belo Horizonte - Unibh
Belo Horizonte, Minas Gerais, 30575-180
Ceti Centro Est Terap Inovadoras
Curitiba, Paraná, 80030-110
Universidade Federal do Parana
Curitiba, Paraná, 80060-240
Cecip Centro Est Clin Int Paulista
Jaú, São Paulo, 17201-130
Irmandade da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90020-090
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
Hospital Ernesto Dornelles
Porto Alegre, Rio Grande do Sul, 90160-093
IBPClin Instituto Brasil de Pesquisa Clinica
Rio de Janeiro, 20241-180
Clinica Instituto Bahiano de Imunoterapia - Medicina, Reumatologia e Dermatologia ltda
Salvador, Estado de Bahia, 41820-020
Fundacao Abc - Centro Univ Fmabc
Santo André, São Paulo, 09060-870
Cemec Centro Multidisciplinar Estudos Clinicos
São Bernardo do Campo, São Paulo, 09715-090
Hospital de Base de Sao Jose do Rio Preto
São José do Rio Preto, São Paulo, 15090-000
Ispem - Instituto Sao Jose dos Campos em Pesquisas Medicas
São José dos Campos, São Paulo, 12243-280
Instituto Pesquisa e Ensino em Saúde Infantil
São Paulo, São Paulo, 01228-200
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
São Paulo, São Paulo, 01308-050
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, 05403-002
Consultoria Medica e Pesquisa Clinica Cmpc
Sorocaba, São Paulo, 18040-425
Centro do Diagnostico e Pesquisa da Osteoporose do Espirito Santo
Vitória, Espírito Santo, 29055-450
South Korea19 sites
Korea University Ansan Hospital
Ansansi, Gyeonggido, 15355
SoonChunHyang University Hospital Bucheon
Bucheon-si, Gyeonggi-do, 14584
Chosun University Hospital
Gwangju, 61453
The Catholic University of Korea Incheon St Marys Hospital
Incheon, 21431
Inha University Hospital
Incheon, 22332
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Korea University Anam Hospital
Seoul, 02841
Seoul National University Hospital
Seoul, 03080
Severance Hospital Yonsei University Health System
Seoul, 03722
National Medical Center
Seoul, 04564
Konkuk University Medical Center
Seoul, 05030
Kyung Hee University Hospital at Gangdong
Seoul, 05278
Asan Medical Center
Seoul, 05505
The Catholic University of Korea Seoul St Marys Hospital
Seoul, 06591
Chung-Ang University Hospital
Seoul, 06973
Hallym University Kangnam Sacred Heart Hospital
Seoul, 07441
Ewha Womans University Seoul Hospital
Seoul, 07804
Korea University Guro Hospital
Seoul, 08308
Ajou University Hospital
Suwon-si, Gyeonggi-do, 16499
Argentina14 sites
Buenos Aires Skin SA
Buenos Aires, Distrito Federal, 1054
Fundacion Cidea
Buenos Aires, Distrito Federal, 1121
Care- Centro de Alergia y Enfermedades Respiratorias
Buenos Aires, Distrito Federal, 1414
Instituto de Neumonologia y Dermatologia
Buenos Aires, Distrito Federal, 1425
Psoriahue Medicina Interdisciplinaria SRL
Buenos Aires, Distrito Federal, 1425
Conexa Investigacion Clinica SA
CABA, Buenos Aires, C1012AAY
InAER - Investigaciones en Alergia y Enfermedades Respiratorias
CABA, Distrito Federal, 1425
Cinme - Centro de Investigaciones Metabolicas
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1056ABI
Fundacion Respirar
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1426ABP
Hospital Universitario Austral
Derqui, Pilar, Buenos Aires, B1629ODT
Framingham Centro Medico
La Plata, Buenos Aires, B1902COS
Centro de Investigaciones Clinicas Instituto Especialidades De La Salud De Rosario
Rosario, Santa Fe Province, 2000
Fundacion Estudios Clinicos
Rosario, Santa Fe Province, 2000
Instituto de Diagnostico abc
Rosario, Santa Fe Province, 2000
Australia14 sites
The Skin Centre
Benowa, Queensland, 4217
Box Hill Hospital
Box Hill, Victoria, 3128
Emeritus Research Camberwell
Camberwell, Victoria, 3124
Skin Health Institute
Carlton, Victoria, 3053
Monash Childrens Hospital
Clayton, Victoria, 3168
Premier Specialists
Kogarah, New South Wales, 2217
St George Dermatology and Skin Cancer Centre
Kogarah, New South Wales, 2217
Liverpool Hospital
Liverpool, New South Wales, 2170
The Alfred Hospital
Melbourne, Victoria, 3004
Institute for Skin Health and Immunity
Mitcham, Victoria, 3132
The Royal Melbourne Hospital
Parkville, Victoria, 3050
Princess Alexandra Hospital
South Brisbane, Queensland, 4101
Royal North Shore Hospital
St Leonards, New South Wales, 2065
Veracity Clinical Research
Woolloongabba, Queensland, 4102
Czechia14 sites
Kozni ambulance Kutna Hora sro
Kutná Hora, 284 01
Dermamedica, sro
Náchod, 547 01
Nemocnice Novy Jicin as
Nový Jičín, 741 01
CCR Ostrava sro
Ostrava, 702 00
Pratia Pardubice as
Pardubice, 530 02
Fakultni nemocnice Plzen
Pilsen, 305 99
Clintrial sro
Prague, 100 00
Dermamedest sro
Prague, 120 00
Pratia Prague sro
Prague, 130 00
Kozni ambulance Fialova sro
Prague, 160 00
Fakultni nemocnice Bulovka
Prague, 180 81
Praglandia sro
Praha 5 - Smichov, 150 00
Dermatologicka ambulance MUDr Petr Trestik
Svitavy, 568 02
Krajska zdravotni as - Masarykova nemocnice Usti nad Labem oz
Ústí nad Labem, 401 13
Hungary11 sites
Trial Pharma Kft
Békéscsaba, 5600
Csalogany Orvosi Kozpont
Budapest, 1027
Clinexpert Kft
Budapest, 1033
Obudai Egeszsegugyi Centrum Kft
Budapest, 1036
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032
Gyongyosi Bugat Pal Korhaz
Gyöngyös, 3200
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Kaposvár, 7400
DermaMed Research Kft
Orosháza, 5900
Allergo-Derm Bakos Kft
Szolnok, 5000
Medmare Bt
Veszprém, 8200
Obudai Egeszsegugyi Centrum Kft
Zalaegerszeg, 8900
France10 sites
Hopital Prive d Antony
Antony, 92160
Polyclinique de Courlancy
Bezannes, 51430
Centre Hospitalier Regional Universitaire de Brest - Hopital Morvan
Brest, 29200
Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez
Lille, 59037
Centre Hospitalier de Bretagne Sud - Hopital du Scorff
Lorient, 56322
Cabinet du Docteur Ruer-Mulard Mireille
Martigues, 13500
Centre Hospitalier Universitaire Archet 2
Nice, 06202
Hopital Saint Louis
Paris, 75475
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
Rennes, 35033
Centre Hospitalier Universitaire de Rouen - Hopital Charles Nicolle
Rouen, 76000
Turkey (Türkiye)9 sites
Ankara Bilkent Sehir Hastanesi
Ankara, 06800
Gaziantep Universitesi Tip Fakultesi Hastanesi
Gaziantep, 27310
Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
Istanbul, 34390
Acibadem Altunizade Hastanesi
Istanbul, 34662
Marmara Universitesi Tip Fakultesi Hastanesi
Istanbul, 34899
Bakircay Universitesi Cigli Egitim ve Arastirma Hastanesi
Izmir, 35620
Erciyes Universitesi Tip Fakultesi Hastanesi
Kayseri, 38030
Kocaeli Universitesi Tip Fakultesi Hastanesi
Kocaeli, 41380
Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
Samsun, 55200
Italy8 sites
Universita degli Studi Gabriele D Annunzio di Chieti e Pescara
Chieti, 66100
Ospedale San Salvatore
LAquila, 67100
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, 20122
Azienda Ospedaliera Universitaria Luigi Vanvitelli
Naples, 80131
Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia
Perugia, 06156
Azienda Ospedaliera Policlinico Umberto I
Roma, 00161
IRCCS Istituto Clinico Humanitas
Rozzano MI, 20089
Azienda Ospedaliera Citta della Salute e della Scienza di Torino
Torino, 10126
Belgium7 sites
Universite Catholique de Louvain Cliniques Universitaires Saint Luc
Brussels, 1200
Grand Hopital de Charleroi - Site des Viviers
Charleroi, 6060
Universitair Ziekenhuis Gent
Ghent, 9000
Clinique Andre Renard
Herstal, 4040
Dermatologie Handelskaai
Kortrijk, 8500
Centre Hospitalier Universitaire de Liege - Sart Tilman
Liège, 4000
Dermatologie Maldegem
Maldegem, 9990
Greece7 sites
University General Hospital Attikon
Athens, 12462
Andreas Syngros Hospital Of Venereal And Dermatological Diseases
Athens, 16121
University General Hospital of Ioannina
Ioannina, 45500
General University Hospital of Larissa
Larissa, 41110
General Hospital Of Nea Ionia Konstantopouleio Patision
Nea Ionia, 14233
Geniko Nosokomeio Peiraia Tzaneio
Piraeus, 18536
Papageorgiou General Hospital
Thessaloniki, 56429
Slovakia6 sites
Fakultna Nemocnica s poliklinikou F D Roosevelta Banska Bystrica
Banská Bystrica, 975 17
Maxderm, sro
Bardejov, 085 01
Univerzitna nemocnica Bratislava - Nemocnica Stare Mesto
Bratislava, 813 69
Derma therapy, spol s ro
Bratislava, 851 01
Sanare spol sro
Svidník, 089 01
Kaderma Majtan, sro
Topoľčany, 955 01
Taiwan6 sites
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301
National Cheng Kung University Hospital
Tainan, 70403
National Taiwan University Hospital
Taipei, 10002
Mackay Memorial Hospital Taipei Branch
Taipei, 10449
Taipei Veterans General Hospital
Taipei, 11217
Linkou Chang Gung Memorial Hospital
Taoyuan, 33305
United Kingdom6 sites
Alder Hey Childrens Hospital
Liverpool, L12 2AP
Whipps Cross University Hospital
London, E11 1NR
The Royal Free Hospital
London, NW3 2PF
Guys Hospital
London, SE1 9RT
Salford Care Organisation
Salford, M6 8HD
Accellacare Yorkshire
Shipley, BD18 3SA
Bulgaria5 sites
Medical Center Asklepii OOD
Dupnitsa, 2600
Medical Center Medconsult Pleven OOD
Pleven, 5800
Medical Center Excelsior OOD
Sofia, 1407
Diagnostic-Consultative Center Alexandrovska EOOD
Sofia, 1431
Diagnostic-Consultative Center - Fokus-5 - Medical Institution for Outpatient Care OOD
Sofia, 1463
Chile5 sites
Hospital Base San Jose de Osorno
Osorno, 5311523
Centro Medico Skinmed Spa
Santiago, 7580206
Clinica Dermacross SA
Santiago, 7640881
Fundacion Innovacion Cardiovascular Clinica Ensenada
Santiago, 8380465
Centro Internacional de Estudios Clinicos
Santiago
Portugal5 sites
Unidade de Saude Local de Almada-Seixal, EPE - Hospital Garcia de Orta
Almada, 2801-951
Unidade Local de Saude de Coimbra, EPE
Coimbra, 3000-075
Hospital Cuf Descobertas
Lisbon, 1998-018
Unidade Local de Saude de Santo Antonio, EPE - Hospital de Santo Antonio
Porto, 4099-001
Unidade Local de Saude de Sao Joao, EPE - Hospital de Sao Joao
Porto, 4200-319
Malaysia4 sites
Hospital Pulau Pinang
George Town, Pulau Pinang, 10990
Hospital Raja Permaisuri Bainun
Ipoh, Perak, 30450
Hospital Sultan Ismail
Johor Bahru, Johor, 81100
University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, 59100
Thailand4 sites
King Chulalongkorn Memorial Hospital
Bangkok, 10330
Siriraj Hospital
Bangkok, 10700
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, 50200
Thammasat University Hospital
Pathum Thani, 12120
Croatia3 sites
Special Hospital for Medical Rehabilitation Naftalan
Ivanić-Grad, 10310
Children s Hospital Zagreb
Zagreb, 10000
University Hospital Centre Zagreb
Zagreb, 10000
Finland3 sites
Clinical Research Services Helsinki
Helsinki, 00180
Oulun Yliopistollinen sairaala
Oulu, 90029
Terveystalo Tampere
Tampere, 33100
Latvia3 sites
Outpatient clinic Veselibas Centrs 4
Riga, 1003
Outpatient clinic Veselibascentrs 4
Riga, LV-1013
Smite Aija practice in dermatology and venerology
Talsi, 3201
Netherlands3 sites
Bravis Ziekenhuis
Bergen op Zoom, 4624 VT
Universitair Medisch Centrum Groningen
Groningen, 9700 RB
Universitair Medisch Centrum Utrecht
Utrecht, 3584 CX
Singapore3 sites
National University Hospital
Singapore, 119074
Singapore General Hospital
Singapore, 168753
National Skin Centre
Singapore, 308205
Switzerland3 sites
Inselspital Bern
Bern, 3010
Centre Hospitalier Universitaire Vaudois
Lausanne, 1011
Universitaetsspital Zuerich
Zurich, 8091
Austria2 sites
Medizinische Universitaet Graz
Graz, 8036
Landeskrankenhaus Salzburg
Salzburg, 5020
Estonia2 sites
North Estonia Medical Centre
Tallinn, 13419
Clinical Research Centre
Tartu, 50106
Mexico2 sites
Phylasis Clinical Research
Cuautitlán Izcalli, 54750
Clínica de Enfermedades Crónicas y de Procedimientos Especiales
Morelia, Michoacán, 58249
Slovenia2 sites
Univerzitetni klinicni center Ljubljana
Ljubljana, 1000
Univerzitetni Klinicni Center Maribor
Maribor, 2000
South Africa1 site
Hiway Medical Centre
Westville, Durban, KwaZulu-Natal, 3630
About this study
Official title: 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.
- Conditions
- Atopic Dermatitis
- Being tested
- Rocatinlimab, Placebo
- Keywords
- Atopic Dermatitis, Rocatinlimab, AMG 451, Eczema
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RocatinlimabDrug
Also called AMG 451, KHK4083
Subcutaneous (SC) injection
PlaceboOther
SC injection
| Study group | Role | What they receive |
|---|---|---|
| ARM A: Dose 1 to Dose 1 | Experimental | 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. Receives: Drug: Rocatinlimab |
| ARM B: Dose 2 to Dose 2 | Experimental | 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. Receives: Drug: Rocatinlimab |
| ARM C: Dose 1 or Dose 2 to Placebo | Placebo comparator | 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. Receives: Other: Placebo |
| ARM D: Placebo to Placebo | Placebo comparator | 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. Receives: Other: Placebo |
| ARM E: Dose 1, Dose 2, Placebo, or Open-label (OL) to OL Dose 1 | Experimental | 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 continue to receive OL Rocatinlimab Dose 1 Q4W. Receives: Drug: Rocatinlimab |
| ARM F Group | No intervention | Participants in Arm E (OL Rocatinlimab Dose 1 Q4W) who meet defined criteria will have Rocatinlimab withdrawn, but will continue all subsequent study visits. |
| ARM G Group | Experimental | Participants from Arm F who meet defined criteria will resume OL Rocatinlimab Dose 1 Q4W. Receives: Drug: Rocatinlimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-emergent Adverse Events
Measured: Up to 116 weeks
Secondary outcomes (6)
Maintaining Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD™) 0/1 Response at Week 32 Among Participants Achieving vIGA-AD™ 0/1 Response at Day 1
This outcome measure applies only to participants from parent rocatinlimab studies ROCKET-Ignite and ROCKET-Horizon who entered into the randomized treatment withdrawal cohort.
Measured: Week 32
Maintaining a Revised IGA (rIGA™) 0/1 Response at Week 32 Among Participants Achieving rIGA™ 0/1 Response at Day 1
This outcome measure applies only to participants from parent rocatinlimab studies ROCKET-Ignite and ROCKET-Horizon who entered into the randomized treatment withdrawal cohort.
Measured: Week 32
Maintaining Eczema Area and Severity Index (EASI) 75 Response at Week 32 Among Participants Achieving EASI 75 Response at Day 1
This outcome measure applies only to participants from parent rocatinlimab studies ROCKET-Ignite and ROCKET-Horizon who entered into the randomized treatment withdrawal cohort.
Measured: Week 32
Maintaining EASI 90 Response at Week 32 Among Participants Achieving EASI 90 Response at Day 1
This outcome measure applies only to participants from parent rocatinlimab studies ROCKET-Ignite and ROCKET-Horizon who entered into the randomized treatment withdrawal cohort.
Measured: Week 32
Maintaining vIGA-AD™ 0/1 Response and EASI 75 Response at Week 32 Among Participants Achieving vIGA-AD™ 0/1 Response and EASI 75 Response at Day 1
This outcome measure applies only to participants from parent rocatinlimab studies ROCKET-Ignite and ROCKET-Horizon who entered into the randomized treatment withdrawal cohort.
Measured: Week 32
Maintaining ≥ 4-point Reduction from Parent Study Baseline in Worst Pruritus NRS Score at Week 32 Among Participants Achieving ≥ 4 Point Reduction from Parent Study Baseline in Worst Pruritus NRS Score at Day 1
This outcome measure applies only to participants from parent rocatinlimab studies ROCKET-Ignite and ROCKET-Horizon who entered into the randomized treatment withdrawal cohort.
Measured: Week 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start31 May 2023
- Primary completion1 Jul 2026
- Study completion1 Jul 2026
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2,621 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05882877
- Sponsor's protocol ID
- 20210146
- Other IDs
- 2022-501587-17
- Acronym
- ROCKET-ASCEND
- Status last verified
- Jul 2026
- First submitted
- 22 May 2023
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Publications
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.
PubMed 40012373
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05882877
- Acronym / sponsor ID
- ROCKET-ASCEND / 20210146
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic Dermatitis, Rocatinlimab, AMG 451, Eczema
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Decision
- Enrolment
- 2,621 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 31 May 2023 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 31 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| ARM A: Dose 1 to Dose 1 | Experimental | Drug: RocatinlimabParticipants 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. |
| ARM B: Dose 2 to Dose 2 | Experimental | Drug: RocatinlimabParticipants 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. |
| ARM C: Dose 1 or Dose 2 to Placebo | Placebo comparator | Other: PlaceboParticipants 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. |
| ARM D: Placebo to Placebo | Placebo comparator | Other: PlaceboParticipants 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. |
| ARM E: Dose 1, Dose 2, Placebo, or Open-label (OL) to OL Dose 1 | Experimental | Drug: RocatinlimabParticipants 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 continue to receive OL Rocatinlimab Dose 1 Q4W. |
| ARM F Group | No intervention | –Participants in Arm E (OL Rocatinlimab Dose 1 Q4W) who meet defined criteria will have Rocatinlimab withdrawn, but will continue all subsequent study visits. |
| ARM G Group | Experimental | Drug: RocatinlimabParticipants from Arm F who meet defined criteria will resume OL Rocatinlimab Dose 1 Q4W. |
Who may qualify
- Ages
- 12 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
- Participants from the parent study ROCKET-ORBIT must achieve an improvement in EASI score at week 52 of at least 60% compared to parent study baseline (EASI 60).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RocatinlimabAlso: AMG 451, KHK4083Subcutaneous (SC) injection | Drug | ARM A: Dose 1 to Dose 1, ARM B: Dose 2 to Dose 2, ARM E: Dose 1, Dose 2, Placebo, or Open-label (OL) to OL Dose 1, ARM G Group |
| PlaceboSC injection | Other | ARM C: Dose 1 or Dose 2 to Placebo, ARM D: Placebo to Placebo |
Primary outcome
Number of Participants With Treatment-emergent Adverse Events
Time frame: Up to 116 weeks
6 secondary outcomes
Maintaining Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD™) 0/1 Response at Week 32 Among Participants Achieving vIGA-AD™ 0/1 Response at Day 1
Time frame: Week 32
Maintaining a Revised IGA (rIGA™) 0/1 Response at Week 32 Among Participants Achieving rIGA™ 0/1 Response at Day 1
Time frame: Week 32
Maintaining Eczema Area and Severity Index (EASI) 75 Response at Week 32 Among Participants Achieving EASI 75 Response at Day 1
Time frame: Week 32
Maintaining EASI 90 Response at Week 32 Among Participants Achieving EASI 90 Response at Day 1
Time frame: Week 32
Maintaining vIGA-AD™ 0/1 Response and EASI 75 Response at Week 32 Among Participants Achieving vIGA-AD™ 0/1 Response and EASI 75 Response at Day 1
Time frame: Week 32
Maintaining ≥ 4-point Reduction from Parent Study Baseline in Worst Pruritus NRS Score at Week 32 Among Participants Achieving ≥ 4 Point Reduction from Parent Study Baseline in Worst Pruritus NRS Score at Day 1
Time frame: Week 32
Results and safety
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Background: PubMed 40012373Guttman-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.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
547 sites in 42 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rocatinlimab in people with Atopic Dermatitis, run by Amgen at 547 sites in 42 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 547 sites in United States, Japan, Canada, China, Poland and 37 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-emergent Adverse Events (time frame: Up to 116 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05882877, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.