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

ID#: NCT05633355

Age: 12 - 17 years

Gender: All

Healthy Subjects: No

Study Phase: Phase 3

Recruitment Status: Recruiting

Start Date: January 30, 2023

End Date: April 21, 2025

Contact Information:
Amgen Call Center
Summary: The primary objective of this study is to describe the safety and tolerability of rocatinlimab in adolescents with moderate-to-severe AD.

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