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NCT05651711 · ClinicalTrials.gov registry record · Phase 3
A Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon)
A Phase 3 study of Atopic Dermatitis, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 726
- Enrollment target
- 20
- Study locations
NCT05651711: Completed Phase 3 study of Atopic Dermatitis, sponsored by Amgen.
NCT05651711 is a Phase 3 study of Atopic Dermatitis that has completed, run by Amgen. The registered enrollment target is 726 participants, above the 605-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (20% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05651711, a Phase 3 study of Atopic Dermatitis, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 726 participants
- Enrollment target
- 20
- Study locations
Study Summary
The co-primary objectives of the study are to: * Evaluate the efficacy of rocatinlimab compared with placebo at Week 24, assessed using Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD). * Evaluate the efficacy of rocatinlimab compared with placebo 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," th
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Rocatinlimab
Study Locations (20)
California
- Velocity Clinical Research Chula Vista - Chula Vista
- West Coast Research LLC - Dublin
- California Dermatology and Clinical Research Institute - Encinitas
- Center for Dermatology Clinical Research Inc - Fremont
- Velocity Clinical Research - San Diego - La Mesa
- Velocity Clinical Research - North Hollywood - North Hollywood
- Cura Clinical Research - Palmdale
- University of California at San Francisco, Dermatology Clinic at Mount Zion - San Francisco
- Clinical Science Institute - Santa Monica
Florida
- Renaissance Research and Medical Group - Cape Coral
- Driven Research LLC - Coral Gables
- Saint Jude Clinical Research - Doral
- Direct Helpers Research Center - Hialeah
Arizona
- Research Solutions of Arizona, PC - Litchfield Park
- Center for Dermatology and Plastic Surgery - Scottsdale
Arkansas
- Clinical Trials Institute of Northwest Arkansas - Fayetteville
- Burke Pharmaceutical Research - Hot Springs
Colorado
- Clarity Dermatology - Castle Rock
- Velocity Clinical Research - Denver - Denver
District of Columbia
- Foxhall Research Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 726 participants |
| Start Date | 2022-12-14 |
| Est. Completion | 2024-08-27 |
| Phase | Phase 3 |
What the finished NCT05651711 record still lists
NCT05651711 is an interventional study that assigns participants to a tested intervention. The registered 726 participants enrollment target is mid-sized for trials with a published cap, above the 605-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (20% 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.
NCT05651711 names 20 study sites across 6 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT05651711 about?
NCT05651711 is a clinical study titled "A Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon)". The co-primary objectives of the study are to: * Evaluate the efficacy of rocatinlimab compared with placebo at Week 24, assessed using Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD). * Evaluate the efficacy of rocatinlimab compared with placebo at Week 24, assessed usin...
What is the current status of trial NCT05651711?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 726 participants. The study started on 2022-12-14. Estimated completion is 2024-08-27.
What conditions does trial NCT05651711 study?
This clinical trial studies the following conditions: Atopic Dermatitis.
What interventions are being tested in trial NCT05651711?
The interventions under investigation include: Placebo (OTHER), Rocatinlimab (DRUG).
Who is sponsoring clinical trial NCT05651711?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05651711 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05651711's enrollment target sits among peer trials
726 20th of 150 higher than 131 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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