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 (in combination with topical treatment – for combination therapy cohort). Following re-randomization at Week 24, all participants will receive active study drug. 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 68 weeks and involve about 19 visits to the study centre.
Saskatoon - Skinsense Medical Research
Windsor - XLR8 Medical Research
Niagara Falls - Allergy Research Canada Inc.
Markham - Lynderm Research Inc.
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Last Update Posted: December 10, 2023
NCT05704738
Amgen
Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy and combination therapy treatment in adolescent subjects.
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. Diagnosis of AD (according to American Academy of Dermatology Consensus Criteria [Eichenfield et al, 2014]) that has been present for at least 12 months before signing of informed consent. Body weight ≥ 40 kg at screening. History of inadequate response to TCS of medium to higher potency (with or without TCI). EASI score ≥ 12 at initial screening. EASI score ≥ 16 at Day 1. vIGA-AD score ≥ 3. ≥10% body surface area of AD involvement. Worst pruritus NRS ≥ 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 Non-biologic, non-targeted systemic immunosuppressants Phototherapy 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 TCI Topical phosphodiesterase 4 inhibitors Other topical immunosuppressive agents
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