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NCT05704738 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate Rocatinlimab (AMG 451) in Adolescent 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
- 532
- Enrollment target
- 20
- Study locations
NCT05704738: Completed Phase 3 study of Atopic Dermatitis, sponsored by Amgen.
NCT05704738 is a Phase 3 study of Atopic Dermatitis that has completed, run by Amgen. The registered enrollment target is 532 participants, below the 606-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (12% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05704738, a Phase 3 study of Atopic Dermatitis, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 532 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy and combination therapy treatment in adolescent participants.
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
- DRUG Placebo
- DRUG Rocatinlimab
Study Locations (20)
California
- Center for Dermatology Clinical Research Inc - Fremont
- Doc1 Healthcare Systems Incorporated - Fullerton
- Axon Clinical Research - Inglewood
- Avance Clinical Trials - Laguna Niguel
- Cura Clinical Research - Palmdale
- Integrative Skin Science and Research - Sacramento
- University of California at Davis Medical Center - Sacramento
- Allergy and Asthma Medical Group and Research Center - San Diego
- University of California at San Diego Rady Childrens Hospital San Diego - San Diego
- Clinical Science Institute - Santa Monica
- Cura Clinical Research Sherman Oaks - Sherman Oaks
Florida
- Clinical Research of Brandon - Brandon
- Academic Alliance in Dermatology - Saint Petersburg Office - Clearwater
- Corazon United States of America, LLC doing business as Life Clinical Trials - Coral Springs
Alabama
- Cahaba Dermatology and Skin Health Center - Birmingham
- AllerVie Clinical Research- Cullman - Cullman
Arizona
- Eclipse Clinical Research - Tucson
Arkansas
- Arkansas Research Trials, LLC - North Little Rock
Colorado
- Velocity Clinical Research - Denver - Denver
District of Columbia
- Childrens National Medical Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 532 participants |
| Start Date | 2023-04-20 |
| Est. Completion | 2025-11-25 |
| Phase | Phase 3 |
What the finished NCT05704738 record still lists
NCT05704738 is an interventional study that assigns participants to a tested intervention. The registered 532 participants enrollment target is mid-sized for trials with a published cap, below the 606-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (12% lower).
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.
NCT05704738 names 20 study sites across 7 states, led by California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT05704738 about?
NCT05704738 is a clinical study titled "A Study to Evaluate Rocatinlimab (AMG 451) in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)". The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy and combination therapy treatment in adolescent participants.
What is the current status of trial NCT05704738?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 532 participants. The study started on 2023-04-20. Estimated completion is 2025-11-25.
What conditions does trial NCT05704738 study?
This clinical trial studies the following conditions: Atopic Dermatitis.
What interventions are being tested in trial NCT05704738?
The interventions under investigation include: Placebo (DRUG), Rocatinlimab (DRUG).
Who is sponsoring clinical trial NCT05704738?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05704738 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05704738's enrollment target sits among peer trials
532 23rd of 150 higher than 128 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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