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NCT05524571 · ClinicalTrials.gov registry record · Phase 3
Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease
A Phase 3 study of Thyroid Eye Disease, sponsored by Immunovant Sciences.
- Active
- Registry status
- Phase 3
- Development phase
- 100
- Enrollment target
- 20
- Study locations
NCT05524571: Active Phase 3 study of Thyroid Eye Disease, sponsored by Immunovant Sciences.
NCT05524571 is a Phase 3 study of Thyroid Eye Disease that is active but no longer recruiting, run by Immunovant Sciences. The registered enrollment target is 100 participants, roughly in line with the 100-participant average among 15 other Thyroid Eye Disease trials with a reported enrollment target. The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05524571, a Phase 3 study of Thyroid Eye Disease, is active but no longer recruiting, sponsored by Immunovant Sciences.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 100 participants
- Enrollment target
- 20
- Study locations
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Batoclimab
Study Locations (20)
Other
- Site Number - 7565 - Sydney
- Site Number -4671 - Bruges
- Site Number - 4672 - Brussels
- Site Number - 4673 - Brussels
- Site Number -4670 - Ghent
California
- Site Number -1520 - Pasadena
- Site Number -1517 - San Francisco
- Site Number -1514 - Torrance
Texas
- Site Number -1515 - Bellaire
- Site Number - 1524 - McAllen
- Site Number -1519 - San Antonio
Florida
- Site Number -1510 - Sarasota
Kentucky
- Site Number -1516 - Louisville
Michigan
- Site Number - 1526 - Livonia
Minnesota
- Site Number - 1513 - Rochester
North Carolina
- Site Number - 1512 - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2023-01-05 |
| Est. Completion | 2026-03 |
| Phase | Phase 3 |
What the registry record for NCT05524571 still lists
NCT05524571 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 100-participant average among 15 other Thyroid Eye Disease trials with a reported enrollment target.
The record links to 1 condition, with Thyroid Eye Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05524571 names 20 study sites across 12 states, led by Other, California, Texas.
Frequently Asked Questions
What is clinical trial NCT05524571 about?
NCT05524571 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 NCT05524571?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 100 participants. The study started on 2023-01-05. Estimated completion is 2026-03.
What conditions does trial NCT05524571 study?
This clinical trial studies the following conditions: Thyroid Eye Disease.
What interventions are being tested in trial NCT05524571?
The interventions under investigation include: Placebo (DRUG), Batoclimab (DRUG).
Who is sponsoring clinical trial NCT05524571?
This trial is sponsored by Immunovant Sciences, which has 15 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05524571 being conducted?
This trial has 20 study locations across California, Florida, Kentucky, Michigan, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Thyroid Eye Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05524571's enrollment target sits among peer trials
100 7th of 15 higher than 8 of 15 other Thyroid Eye Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Thyroid Eye Disease 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
-
An Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants With Active Thyroid Eye Disease (TED)
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An Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants With Chronic Thyroid Eye Disease (TED)
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Extension Study to Assess Batoclimab in Participants With Thyroid Eye Disease
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A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Thyroid Eye Disease
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A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Thyroid Eye Disease
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