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NCT05517421 · ClinicalTrials.gov registry record · Phase 3
Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease
A Phase 3 study, sponsored by Immunovant Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 114
- Enrollment target
NCT05517421: Completed Phase 3 study, sponsored by Immunovant Sciences.
NCT05517421 is a Phase 3 study that has completed, run by Immunovant Sciences. The registered enrollment target is 114 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05517421, a Phase 3 study, has completed, sponsored by Immunovant Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 114 participants
- Enrollment target
Study Summary
To evaluate the efficacy of batoclimab 680 milligrams (mg) subcutaneous (SC) once a week (QW) for 12 weeks followed by 340 mg SC QW for 12 weeks versus placebo on proptosis responder rate at Week 24.
Primary Outcome
Proptosis is the amount of protrusion of the eye from the orbital rim. Measurements are recorded using the Hertel exophthalmometer. The study eye is defined as the most severely affected eye at the Baseline visit. Proptosis responder is defined as the participant with a greater than or equal to (≥) 2 millimeters (mm) reduction in the study eye without deterioration (≥2 mm increase) in the fellow eye.
Interventions
- DRUG Placebo
- DRUG Batoclimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 114 participants |
| Start Date | 2022-11-23 |
| Est. Completion | 2025-11-18 |
| Phase | Phase 3 |
What the finished NCT05517421 record still lists
NCT05517421 is an interventional study that assigns participants to a tested intervention. The registered 114 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05517421 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05517421 about?
NCT05517421 is a clinical study titled "Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease". To evaluate the efficacy of batoclimab 680 milligrams (mg) subcutaneous (SC) once a week (QW) for 12 weeks followed by 340 mg SC QW for 12 weeks versus placebo on proptosis responder rate at Week 24.
What is the current status of trial NCT05517421?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 114 participants. The study started on 2022-11-23. Estimated completion is 2025-11-18.
What interventions are being tested in trial NCT05517421?
The interventions under investigation include: Placebo (DRUG), Batoclimab (DRUG).
Who is sponsoring clinical trial NCT05517421?
This trial is sponsored by Immunovant Sciences, which has 15 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05517421's enrollment target sits among peer trials
114 1648th of 2000 higher than 350 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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