Recruiting adolescents from 12 to less than 18 years of age with a diagnosis of atopic dermatitis (AD) for at least 6 months for this research trial. To qualify for the study, individuals must have moderate to severe disease with AD involvement of ≥10% of body surface area. In addition, eligible participants must have a history of inadequate response to topical corticosteroids (TCS) of medium or 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 and 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 68 weeks and involve about 19 visits to the study centre.
Toronto - FACET Dermatology
Hamilton - LEADER Research
Burlington - Halton Pediatric Allergy
Toronto - Toronto Research Centre
Ottawa - JRB Research Inc.
Edmonton - Vida Clinical Research
Calgary - Dermatology Research Institute
Carrara - The Skin Centre
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Last Update Posted: December 10, 2023
NCT05633355
Amgen
Brief Summary:
The primary objective of this study is to describe the safety and tolerability of rocatinlimab in adolescents with moderate-to-severe AD.
Condition or Disease:
Atopic Dermatitis
Intervention/Treatment:
Drug: RocatinlimabPhase:
Phase 3
Ages Eligible for Study:
12 Years and 17 Years (Child)
Sexes Eligible for Study:
All
Inclusion Criteria:
Age ≥ 12 to < 18 years at day 1. Participant has a diagnosis of AD (according to American Academy of Dermatology Consensus Criteria [Eichenfield, 2014]) that has been present for at least 12 months before signing of informed consent Prior to informed consent, history of inadequate response to topical corticosteroids (TCS) of medium to 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) Eczema Area and Severity Index (EASI) score ≥ 12 vIGA-AD score ≥ 3 ≥ 10% BSA of AD involvement at day 1 pre-enrollment 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 Oral or topical janus kinase inhibitors Treatment with any of the following agents within 1 week before day 1 pre-enrollment: Topical PDE4 inhibitors Other topical immunosuppressive agents (not including TCS/TCI) Combination topical agents containing a high- or super-high potency corticosteroid
Terms and Conditions – ClinicalTrials.gov
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