A Study to Evaluate Rocatinlimab (AMG 451) in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD)

• Status: Not yet recruiting
• Trial end date: 2025-08-23
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy and combination therapy treatment in adolescent subjects.

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

Details

• Lead Sponsor: Amgen

Criteria

Inclusion Criteria:

• Age ≥ 12 to < 18 years at Day 1.

• Body weight ≥ 40 kg at screening.

• History of inadequate response to TCS of medium or higher potency within 6 months (with or without TCI).

• EASI score ≥ 16.

• vIGA-AD score ≥ 3.

• ≥10% body surface area (BSA) 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:

1. Systemic corticosteroids

2. Systemic immunosuppressants

3. Phototherapy

4. Oral or Topical Janus kinase inhibitors

• Treatment with any of the following medications or therapies within 1 week, prior to Day 1:

1. TCS

2. TCI

3. Topical phosphodiesterase type 4 inhibitors

4. Other topical immunosuppressive agents