Seeking adults aged 18 and over with a diagnosis of atopic dermatitis (AD) for at least 6 months for this research trial. To qualify for the study, individuals must have AD involvement of ≥10% body surface area, and moderate to severe disease. Eligible participants must also have a history of inadequate response to topical corticosteroids (TCS) of medium or higher potency within 6 months.
Participants will receive an investigational medication (active study drug) or placebo via injection, in combination with topical treatment. 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: March 19, 2023
NCT05724199
Amgen
Brief Summary:
The coprimary objectives of the study are to: To evaluate the efficacy of rocatinlimab in combination with topical corticosteroid and/or topical calcineurin inhibitor (TCS/TCI), compared with placebo in combination with TCS/TCI at Week 24, assessed using Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD). To evaluate the efficacy of rocatinlimab, in combination with TCS/TCI, compared with placebo in combination with TCS/TCI at Week 24, assessed using Eczema Area and Severity Index (EASI).
Condition or Disease:
Atopic Dermatitis
Intervention/Treatment:
Drug: RocatinlimabPhase:
Phase 3
Ages Eligible for Study:
18 Years and 100 Years (Adult)
Sexes Eligible for Study:
All
Inclusion Criteria:
Age ≥ 18 years with a diagnosis of AD according to the AAD (American Academy of Dermatology) Consensus Criteria (2014) present for at least 6 months
History of inadequate response to TCS of medium or higher potency within 6 months (with or without TCI)
EASI score ≥16
vIGA-AD score ≥3
≥10% body surface area (BSA) of AD involvement
Worst pruritus numerical rating scale ≥ 4
Exclusion Criteria:
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:
Systemic corticosteroids
Systemic immunosuppressants
Phototherapy
Janus kinase inhibitors
Treatment with any of the following medications or therapies within 1 week, prior to Day 1:
TCS
TCI
Anti-pruritic agents
Topical phosphodiesterase type 4 inhibitors
Other topical immunosuppressive agents
Combination topical agents including TCS of any potency or TCI, PDE4 inhibitors, or 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.
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