Trials / Completed
CompletedNCT05524571
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
- 86 (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
- 2023-01-05
- Primary completion
- 2026-02-03
- Completion
- 2026-03-03
- First posted
- 2022-09-01
- Last updated
- 2026-04-01
Locations
45 sites across 11 countries: United States, Australia, Belgium, Germany, Hungary, Latvia, New Zealand, Puerto Rico, Slovakia, Spain, Turkey (Türkiye)
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05524571. Inclusion in this directory is not an endorsement.