A Study Assessing Rocatinlimab in Combination With Topical Corticosteroid and/or Topical Calcineurin Inhibitors in Adult Participants With Moderate-to-severe Atopic Dermatitis (AD)
Completed · Phase 3 · Has a placebo group
Conditions studied: Atopic Dermatitis
In brief
The coprimary objectives of the study are to: * evaluate the efficacy of rocatinlimab in combination with topical corticosteroid and/or topical calcineurin inhibitor (TCS/TCI), compared with placebo in combination with TCS/TCI at Week 24, assessed using Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD™). * evaluate the efficacy of rocatinlimab, in combination with TCS/TCI, compared with placebo in combination with TCS/TCI at Week 24, assessed using Eczema Area and Severity Index (EASI).
Key facts
- Study ID
- NCT05724199
- Run by
- Amgen
- People needed
- 746
- Starts
- 2023-02-21
- Expected to finish
- 2024-12-04
- Last updated by the study team
- 2026-08-06
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 (American Academy of Dermatology) Consensus Criteria (2014) present for at least 12 months
- History of inadequate response to TCS of medium or higher potency (with or without 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
- Nonbiologic, non-targeted Systemic immunosuppressants
- Phototherapy
- Janus kinase inhibitors
- Treatment with any of the following medications or therapies within 1 week, prior to Day 1:
- TCS
- TCI
- Topical phosphodiesterase type 4 inhibitors
- Other topical immunosuppressive agents
- Combination topical agents including TCS of any potency or TCI, PDE4 inhibitors, or other topical immunosuppressive agents
Where it is running
- Medical Dermatology Specialists — Phoenix, Arizona, United States
- Southwest Skin Specialists — Phoenix, Arizona, United States
- US Dermatology Partners Sun City West — Sun City West, Arizona, United States
- Arkansas Research Trials, LLC — North Little Rock, Arkansas, United States
- Kern Research Inc — Bakersfield, California, United States
- Keck Medicine of University of Southern California — Los Angeles, California, United States
- Wallace Medical Group Inc — Los Angeles, California, United States
- Antelope Valley Clinical Trials — Palmdale, California, United States
- University of California at Davis Medical Center — Sacramento, California, United States
- Kaiser Permanente South Sacramento Medical Center — Sacramento, California, United States
- Acclaim Clinical Research — San Diego, California, United States
- Kaiser Permanente Medical Center - Oakland — San Francisco, California, United States
- Kaiser Permanente Medical Center - San Francisco — San Francisco, California, United States
- Synergy Dermatology — San Francisco, California, United States
- TrueBlue Clinical Research — Tampa, Florida, United States
- Olympian Clinical Research - Tampa — Tampa, Florida, United States
- Atlanta Dermatology, Vein and Research Center, PC — Alpharetta, Georgia, United States
- Divine Dermatology and Aesthetics — Atlanta, Georgia, United States
- NorthShore University HealthSystem — Skokie, Illinois, United States
- DS Research — Clarksville, Indiana, United States
- Dawes Fretzin Clinical Research Group, LLC — Indianapolis, Indiana, United States
- Dermatology and Skin Cancer Center Leawood — Leawood, Kansas, United States
- Industrial Medicine Associates Clinical Research Advanced Dermatology Care — Monroe, Louisiana, United States
- Aesthetic and Dermatology Center — Rockville, Maryland, United States
- The University of Alabama at Birmingham — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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