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NCT05724199 · ClinicalTrials.gov registry record · Phase 3
A Study Assessing Rocatinlimab in Combination With Topical Corticosteroid and/or Topical Calcineurin Inhibitors in Adult Participants With Moderate-to-severe Atopic Dermatitis (AD)
A Phase 3 study of Atopic Dermatitis, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 746
- Enrollment target
- 20
- Study locations
NCT05724199: Completed Phase 3 study of Atopic Dermatitis, sponsored by Amgen.
NCT05724199 is a Phase 3 study of Atopic Dermatitis that has completed, run by Amgen. The registered enrollment target is 746 participants, above the 604-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (24% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05724199, a Phase 3 study of Atopic Dermatitis, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 746 participants
- Enrollment target
- 20
- Study locations
Study Summary
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).
Primary Outcome
vIGA-AD was a validated instrument rating AD severity on a 5-point scale (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe), with higher scores indicating greater severity. Participants achieving a score of 0 or 1 with ≥2-point reduction from baseline were considered 'Clear' or 'Almost clear'. For rIGA 0/1, when vIGA-AD = 1, investigators answered: "Did participant have barely perceptible erythema, no induration/papulation, no lichenification, and no oozing/crusting?" If "Yes," pa
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Rocatinlimab
Study Locations (20)
California
- Kern Research Inc - Bakersfield
- Keck Medicine of University of Southern California - Los Angeles
- Wallace Medical Group Inc - Los Angeles
- Antelope Valley Clinical Trials - Palmdale
- University of California at Davis Medical Center - Sacramento
- Kaiser Permanente South Sacramento Medical Center - Sacramento
- Acclaim Clinical Research - San Diego
- Kaiser Permanente Medical Center - Oakland - San Francisco
- Kaiser Permanente Medical Center - San Francisco - San Francisco
- Synergy Dermatology - San Francisco
Arizona
- Medical Dermatology Specialists - Phoenix
- Southwest Skin Specialists - Phoenix
- US Dermatology Partners Sun City West - Sun City West
Florida
- TrueBlue Clinical Research - Tampa
- Olympian Clinical Research - Tampa - Tampa
Georgia
- Atlanta Dermatology, Vein and Research Center, PC - Alpharetta
- Divine Dermatology and Aesthetics - Atlanta
Alabama
- The University of Alabama at Birmingham - Birmingham
Arkansas
- Arkansas Research Trials, LLC - North Little Rock
Illinois
- NorthShore University HealthSystem - Skokie
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 746 participants |
| Start Date | 2023-02-21 |
| Est. Completion | 2024-12-04 |
| Phase | Phase 3 |
What the finished NCT05724199 record still lists
NCT05724199 is an interventional study that assigns participants to a tested intervention. The registered 746 participants enrollment target is mid-sized for trials with a published cap, above the 604-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (24% higher).
The record links to 1 condition, with Atopic Dermatitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05724199 names 20 study sites across 7 states, led by California, Arizona, Florida.
Frequently Asked Questions
What is clinical trial NCT05724199 about?
NCT05724199 is a clinical study titled "A Study Assessing Rocatinlimab in Combination With Topical Corticosteroid and/or Topical Calcineurin Inhibitors in Adult Participants With Moderate-to-severe Atopic Dermatitis (AD)". 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 fo...
What is the current status of trial NCT05724199?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 746 participants. The study started on 2023-02-21. Estimated completion is 2024-12-04.
What conditions does trial NCT05724199 study?
This clinical trial studies the following conditions: Atopic Dermatitis.
What interventions are being tested in trial NCT05724199?
The interventions under investigation include: Placebo (OTHER), Rocatinlimab (DRUG).
Who is sponsoring clinical trial NCT05724199?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05724199 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05724199's enrollment target sits among peer trials
746 18th of 150 higher than 133 of 150 other Atopic Dermatitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Atopic Dermatitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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