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

Amgen

Status and phase

Active, not recruiting

Phase 3

Conditions

Atopic Dermatitis

Treatments

Drug: Rocatinlimab

Study type

Interventional

Funder types

Industry

Identifiers

20210263

2022-001548-99 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment

187 patients

Sex

All

Ages

12 to 17 years old

Volunteers

No Healthy Volunteers

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