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.
Edmonton - Alberta DermaSurgery Centre
Calgary - Dermatology Research Institute
Newmarket - Dr. S. K. Siddha Medicine Professional Corporation
Waterloo - Alliance Clinical Trials
Toronto - Toronto Research Centre
Richmond Hill - The Centre for Dermatology
Ottawa - Dermatology Ottawa Research Centre
Ottawa - JRB Research Inc.
Toronto - North York Research Inc.
North Bay - North Bay Dermatology Centre
Niagara Falls - Allergy Research Canada Inc.
Cobourg - SKiN Health
Bexley - Bexley Dermatology Research
Las Vegas - Vivida Dermatology
Winnipeg - Wiseman Dermatology Research Inc.
Surrey - Enverus Medical Research
Woolloongabba - Veracity Clinical Research
Carrara - The Skin Centre
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Last Update Posted: September 24, 2023
NCT05724199
Amgen
Brief Summary:
The coprimary objectives of the study are 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™). 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 12 months
History of inadequate response to TCS of medium or higher potency (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
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
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