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

• Status: Not yet recruiting
• Trial end date: 2025-03-14
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen

Criteria

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 6 months before signing of informed consent

• History of inadequate response to TCS (Topical Corticosteroid) of medium or higher potency within 6 months (with or without topical calcineurin inhibitors [TCI])

• Eczema Area and Severity Index (EASI) score ≥ 16

• 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:

• TCS

• TCI

• Anti-pruritic agents

• Topical phosphodiesterase type 4 (PDE4) inhibitors

• Other topical immunosuppressive agents

• Combination topical agents