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NCT05398445 · ClinicalTrials.gov registry record · Phase 3
A Study Evaluating Rocatinlimab in Moderate-to-severe Atopic Dermatitis (ROCKET-IGNITE)
A Phase 3 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 769
- Enrollment target
NCT05398445: Completed Phase 3 study, sponsored by Amgen.
NCT05398445 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 769 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05398445, a Phase 3 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 769 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy treatment.
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
Interventions
- DRUG Placebo
- DRUG Rocatinlimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 769 participants |
| Start Date | 2022-05-31 |
| Est. Completion | 2025-01-13 |
| Phase | Phase 3 |
What the finished NCT05398445 record still lists
NCT05398445 is an interventional study that assigns participants to a tested intervention. The registered 769 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05398445 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05398445 about?
NCT05398445 is a clinical study titled "A Study Evaluating Rocatinlimab in Moderate-to-severe Atopic Dermatitis (ROCKET-IGNITE)". The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy treatment.
What is the current status of trial NCT05398445?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 769 participants. The study started on 2022-05-31. Estimated completion is 2025-01-13.
What interventions are being tested in trial NCT05398445?
The interventions under investigation include: Placebo (DRUG), Rocatinlimab (DRUG).
Who is sponsoring clinical trial NCT05398445?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05398445's enrollment target sits among peer trials
769 444th of 2000 higher than 1,556 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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