Adults aged 18 and over with a diagnosis of atopic dermatitis (AD) for at least 6 months are needed for this research trial. Eligible candidates must have a history of inadequate response to topical corticosteroids (TCS) of medium or high potency within 6 months, or for whom topical treatments are otherwise medically inadvisable. In addition, there must be moderate to severe disease with an involvement of eczema on 10% or more of the body surface area (BSA).
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 may 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
NCT05398445
Amgen
Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy treatment.
Condition or Disease:
Atopic Dermatitis
Intervention/Treatment:
Drug: AMG 451Phase:
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 Consensus Criteria (2014) present for at least 6 months
History of inadequate response to TCS (Topical Corticosteroid) of medium or higher potency within 6 months (with or without topical calcineurin inhibitors [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 of any potency
TCI
Anti-pruritic drug
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.
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