Phase
Condition
Eczema (Atopic Dermatitis)
Skin Infections/disorders
Hives (Urticaria)
Treatment
Rocatinlimab AI
Rocatinlimab Prefilled Syringe
Clinical Study ID
Ages 12-100 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥ 12 at Day 1.
Diagnosis of AD according to American Academy of Dermatology (AAD) ConsensusCriteria (2014) that has been present for at least 12 months.
History of inadequate response to Topical Corticosteroids (TCS) of medium to higherpotency (with or without topical calcineurin inhibitors [TCI]).
Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™) score ≥ 3at screening and pre-randomization.
Eczema Area and Severity Index (EASI) score ≥ 16 at initial at screening andpre-randomization.
≥ 10% body surface area (BSA) of AD involvement at screening and pre-randomization.
Exclusion
Exclusion Criteria:
Treatment with a biological product within 12 weeks or 5 half-lives, whichever islonger, prior to day 1 pre-randomization.
Treatment with any of the following medications or therapies within 5 half-livesprior to day 1 pre-randomization:
Systemic corticosteroids
Non-biologic, non-targeted systemic immunosuppressants
Oral or Topical Janus kinase inhibitors
- Treatment with any of the following medications or therapies within 1 week beforeday 1 pre-randomization:
Topical phosphodiesterase 4 (PDE4) inhibitors
Other topical immunosuppressive agents (not including TCS/TCI)
Combination topical agents containing any of the above components
Study Design
Connect with a study center
Interior Dermatology Centre
Kelowna, British Columbia V1W 4V5
CanadaSite Not Available
LEADER Research
Hamilton, Ontario L8L 3C3
CanadaSite Not Available
Lynderm Research Inc
Markham, Ontario L3P 1X3
CanadaSite Not Available
DermEdge Research Incorporated
Mississauga, Ontario L4Y 4C5
CanadaSite Not Available
Allergy Research Canada Incorporated
Niagara Falls, Ontario L2H 1H5
CanadaSite Not Available
North Bay Dermatology Centre
North Bay, Ontario P1B 3Z7
CanadaSite Not Available
Dermatology Ottawa Research Centre
Ottawa, Ontario K2C 3N2
CanadaSite Not Available
FACET Dermatology
Toronto, Ontario M4E 1R7
CanadaSite Not Available
Alliance Clinical Trials
Waterloo, Ontario N2J 1C4
CanadaSite Not Available
XLR8 Medical Research, Incorporated
Windsor, Ontario N8T 1E6
CanadaSite Not Available
Skinsense Medical Research
Saskatoon, Saskatchewan S7K 2C1
CanadaSite Not Available
Ekihigashi Dermatology Allergy Clinic
Fukuoka-shi, Fukuoka 812-0013
JapanSite Not Available
Fukuoka University Hospital
Fukuoka-shi, Fukuoka 814-0180
JapanSite Not Available
Matsuo Clinic
Fukuoka-shi, Fukuoka 819-0373
JapanSite Not Available
Suizenji Dermatology Clinic
Kumamoto-shi, Kumamoto 862-0950
JapanSite Not Available
Dermatology and Ophthalmology Kume Clinic
Sakai-shi, Osaka 593-8324
JapanSite Not Available
Mita Dermatology Clinic
Minato-ku, Tokyo 108-0014
JapanSite Not Available
Keio University Hospital
Shinjuku-ku, Tokyo 160-8582
JapanSite Not Available
Korea University Ansan Hospital
Ansan-si, Gyeonggi-do, 15355
Korea, Republic ofSite Not Available
Asan Medical Center
Seoul, 05505
Korea, Republic ofSite Not Available
Hallym University Kangnam Sacred Heart Hospital
Seoul, 07441
Korea, Republic ofSite Not Available
Kyung Hee University Hospital at Gangdong
Seoul, 05278
Korea, Republic ofSite Not Available
Severance Hospital Yonsei University Health System
Seoul, 03722
Korea, Republic ofSite Not Available
The Catholic University of Korea Seoul St Marys Hospital
Seoul, 06591
Korea, Republic ofSite Not Available
Ajou University Hospital
Suwon-si, Gyeonggi-do, 16499
Korea, Republic ofSite Not Available
Kern Research Inc
Bakersfield, California 93301
United StatesSite Not Available
Long Beach Research Institute
Long Beach, California 90805
United StatesSite Not Available
Dermatology Research Associates
Los Angeles, California 90045
United StatesSite Not Available
Havana Research Institute Inc
Pasadena, California 91105
United StatesSite Not Available
Integrative Skin Science and Research
Sacramento, California 95815
United StatesSite Not Available
Direct Helpers Research Center
Hialeah, Florida 33012
United StatesSite Not Available
Anchor Medical Research
Miami, Florida 33176
United StatesSite Not Available
Hamilton Research, LLC
Alpharetta, Georgia 30022
United StatesSite Not Available
Treasure Valley Medical Research
Boise, Idaho 83706
United StatesSite Not Available
Dermatology and Skin Cancer Center Leawood
Leawood, Kansas 66211
United StatesSite Not Available
Excel Clinical Research
Las Vegas, Nevada 89109
United StatesSite Not Available
Las Vegas Clinical Trials
North Las Vegas, Nevada 89030
United StatesSite Not Available
Skin Cancer and Dermatology Institute
Reno, Nevada 89509
United StatesSite Not Available
The Skin Surgery Center for Clinical Research
Winston-Salem, North Carolina 27103
United StatesSite Not Available
Bexley Dermatology Research
Bexley, Ohio 43209
United StatesSite Not Available
Apex Clinical Research Center LLC
Mayfield Heights, Ohio 44124
United StatesSite Not Available
Essential Medical Research LLC
Tulsa, Oklahoma 74137
United StatesSite Not Available
Health Concepts
Rapid City, South Dakota 57702
United StatesSite Not Available
Cumberland Skin Center
Hermitage, Tennessee 37076
United StatesSite Not Available
Sms Clinical Research Limited Liability Company
Mesquite, Texas 75149
United StatesSite Not Available
Texas Dermatology Research Center
Plano, Texas 75025
United StatesSite Not Available
Virginia Dermatology and Skin Cancer Center
Norfolk, Virginia 23502
United StatesSite Not Available
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