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A Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)

About

Brief Summary

The primary objective of this study is to describe the safety and tolerability of rocatinlimab in adolescents with moderate-to-severe AD.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase 3

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
12 Years
Maximum Age
17 Years

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

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Protocol No.
23-5142
Category
Healthy Volunteers
Contact
Ross Divinagracia
Location
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
NCT No.
NCT05633355
For detailed technical eligibility, visit ClinicalTrials.gov.