Status:
COMPLETED
A Study Evaluating Rocatinlimab in Moderate-to-severe Atopic Dermatitis (ROCKET-IGNITE)
Lead Sponsor:
Amgen
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18-100 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy treatment.
Eligibility Criteria
Inclusion
- Age ≥ 18 years with a diagnosis of AD according to the AAD Consensus Criteria (2014) present for at least 12 months
- History of inadequate response to TCS (Topical Corticosteroid) of medium to higher potency (with or without topical calcineurin inhibitors \[TCI\]).
- EASI score ≥16
- vIGA-AD score ≥3
- ≥10% body surface area (BSA) of AD involvement
- Worst pruritus numerical rating scale ≥ 4
Exclusion
- 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
- Janus kinase inhibitors
- Treatment with any of the following medications or therapies within 1 week, prior to Day 1:
- TCS of any potency
- TCI
- Topical phosphodiesterase type 4 inhibitors
- Other topical immunosuppressive agents
- Combination topical agents including TCS of any potency, TCI, PDE4 inhibitors, or other topical immunosuppressive agents
Key Trial Info
Start Date :
May 31 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 13 2025
Estimated Enrollment :
769 Patients enrolled
Trial Details
Trial ID
NCT05398445
Start Date
May 31 2022
End Date
January 13 2025
Last Update
November 24 2025
Active Locations (202)
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1
Cahaba Dermatology and Skin Health Center
Birmingham, Alabama, United States, 35244
2
Alliance Dermatology and Mohs Center
Phoenix, Arizona, United States, 85032
3
Anaheim Clinical Trials
Anaheim, California, United States, 92801
4
First OC Dermatology
Fountain Valley, California, United States, 92708