Trials / Completed
CompletedNCT05517421
Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease
A Phase 3, Multi-center, Randomized, Quadruple-masked, Placebo-controlled Study of Batoclimab for the Treatment of Participants With Active Thyroid Eye Disease (TED)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 114 (actual)
- Sponsor
- Immunovant Sciences GmbH · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Batoclimab | Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody |
| DRUG | Placebo | Matching Placebo |
Timeline
- Start date
- 2022-11-23
- Primary completion
- 2025-11-02
- Completion
- 2025-11-18
- First posted
- 2022-08-26
- Last updated
- 2025-12-03
Locations
93 sites across 9 countries: United States, Canada, Georgia, Germany, Israel, Italy, Japan, Poland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05517421. Inclusion in this directory is not an endorsement.