Adults aged 18 and over with a diagnosis of atopic dermatitis (AD) that has been present for at least 6 months, are needed for a research trial. To qualify for the study, individuals must have moderate to severe eczema with involvement of 10% or more body surface area (BSA), and a history of inadequate response to topical corticosteroids (TCS) of medium to higher potency within 6 months, or for whom topical treatments are otherwise medically inadvisable.
Participants will receive an investigational medication (active study drug) or placebo via injection. Study medication and study-related assessments will be provided at no cost. Reimbursement for study-related expenses will be provided.
Study participation will last about 40 weeks and involve about 11 visits to the study centre.
The following information is from ClinicalTrials.gov
Last Update Posted: September 24, 2023
The co-primary objectives of the study are to: Evaluate the efficacy of rocatinlimab compared with placebo at Week 24, assessed using Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD). Evaluate the efficacy of rocatinlimab compared with placebo at Week 24, assessed using Eczema Area and Severity Index (EASI).
Condition or Disease:
Ages Eligible for Study:
18 Years and 100 Years (Adult)
Sexes Eligible for Study:
Age ≥ 18 years (or ≥ legal adult age within the country if it is older than 18 years at signing of informed consent) with a diagnosis of AD according to the AAD Consensus Criteria (2014) present for at least 12 months
History of inadequate response to TCS (Topical Corticosteroid) of medium or higher potency (with or without topical calcineurin inhibitors [TCI]) as appropriate or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks).
EASI score ≥16
vIGA-AD score ≥3
≥10% body surface area (BSA) of AD involvement
Worst pruritus numerical rating scale ≥ 4
Treatment with a biological product within 12 weeks or 5 half-lives, whichever is longer, prior to Day 1
Treatment with any of the following medications or therapies within 4 weeks or 5 half-lives, whichever is longer, prior to Day 1:
Oral or topical Janus kinase inhibitors
Treatment with any of the following medications or therapies within 1 week, prior to Day 1:
TCS of any potency
Topical phosphodiesterase type 4 inhibitors
Other topical immunosuppressive agents
Terms and Conditions – ClinicalTrials.gov
Purpose of ClinicalTrials.gov Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.