A Study Evaluating Rocatinlimab in Moderate-to-severe Atopic Dermatitis (ROCKET-IGNITE)

Completed · Phase 3 · Has a placebo group

Conditions studied: Atopic Dermatitis

In brief

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

Key facts

Study ID

NCT05398445

Run by

Amgen

People needed

769

Starts

2022-05-31

Expected to finish

2025-01-13

Last updated by the study team

2026-07-23

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cahaba Dermatology and Skin Health Center — Birmingham, Alabama, United States
• Alliance Dermatology and Mohs Center — Phoenix, Arizona, United States
• Anaheim Clinical Trials — Anaheim, California, United States
• First OC Dermatology — Fountain Valley, California, United States
• Kaiser Permanente - Glendale Medical Center — Glendale, California, United States
• Long Beach Research Institute — Long Beach, California, United States
• Kaiser Permanente Los Angeles Medical Center — Los Angeles, California, United States
• Dermatology Research Associates — Los Angeles, California, United States
• Cura Clinical Research — Sherman Oaks, California, United States
• IMMUNOe Research Centers — Centennial, Colorado, United States
• Skin Care Research Incorporated — Boca Raton, Florida, United States
• Palm Beach Dermatology Group — Delray Beach, Florida, United States
• Global Research Associates — Homestead, Florida, United States
• Healthy Life Research — Miami, Florida, United States
• Savin Medical Group LLC — Miami Lakes, Florida, United States
• Kirsch Dermatology LLC — Naples, Florida, United States
• Pure Skin Dermatology and Aesthetics — Orlando, Florida, United States
• Industrial Medicine Associates Ima Clinical Research Inc — St. Petersburg, Florida, United States
• Genesis Clinical Research LLC — Tampa, Florida, United States
• Treasure Valley Medical Research — Boise, Idaho, United States
• DeNova Research — Chicago, Illinois, United States
• Dundee Dermatology — West Dundee, Illinois, United States
• The Indiana Clinical Trials Center PC — Plainfield, Indiana, United States
• Institute for Asthma and Allergy — Chevy Chase, Maryland, United States
• Onsite Clinical Solutions — Charlotte, North Carolina, United States

Full record on ClinicalTrials.gov

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