Trials / Completed
CompletedNCT05907668
A Proof-of-Concept Study to Assess Batoclimab in Participants With Graves' Disease
IMVT-1401-2501: A Proof-of-Concept, Open-label Study to Assess the Safety and Efficacy of Batoclimab in Participants With Graves' Disease (GD)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 35 (actual)
- Sponsor
- Immunovant Sciences GmbH · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess the efficacy and safety of 24 weeks of treatment with batoclimab in adult participants with biochemically documented hyperthyroidism due to GD who have failed to achieve euthyroidism on antithyroid drugs (ATDs).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | IMVT-1401 (batoclimab) | Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody. |
Timeline
- Start date
- 2023-05-15
- Primary completion
- 2025-07-25
- Completion
- 2025-07-25
- First posted
- 2023-06-18
- Last updated
- 2026-02-02
Locations
1 site across 1 country: Germany
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05907668. Inclusion in this directory is not an endorsement.