Atopic Dermatitis (ROCKET-Orbit Study)

Study Description

Brief Summary

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

Condition or Disease

Moderate-to-Severe Atopic Dermatitis

Study Design

Study Type:	Interventional (Clinical Trial)
Actual Enrollment:	170 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Phase 3, Open-label, 52-week Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab (AMG 451) in Adolescent Subjects Aged ≥ 12 to < 18 Years With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Orbit)
Actual Study Start Date:	December 23, 2022
Actual Primary Completion Date:	March 14, 2025
Actual Study Completion Date:	March 14, 2025

Eligibility Criteria

Ages Eligible for Study:	12 Years to 17 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

ADDITIONAL DETAILS

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Study Description

Brief Summary

Condition or Disease

Study Design

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Application for Clinical Trials

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