Study to Evaluate the Safety and Efficacy of Batoclimab in Participants With Graves' Disease (GD)

• Status: Recruiting
• Trial end date: 2025-05-01
• Target enrollment: 0
• Participant gender: All

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 with antithyroid drugs (ATDs).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Immunovant Sciences GmbH

Criteria

Inclusion Criteria:

1. Have serologically confirmed GD as documented by presence of elevated stimulatory thyrotropin receptor antibody (TSH-R-Ab) level (i.e., > specimen-to-reference ratio of 140%) at the Screening Visit.

2. Have inadequate response to ADT treatment with the following laboratory values at the Screening Visit:

• TSH < LLN

• FT3 > upper limit of normal (ULN) and <=5 * ULN

• FT4 > ULN and <=5 * ULN

3. Are willing and capable of giving written informed consent, which includes being able to comply with all aspects of the study treatment and testing schedule.

Other, more specific inclusion criteria are defined in the protocol.

Exclusion Criteria:

1. History of hyperthyroidism not caused by GD (e.g., toxic adenoma or toxic multinodular goiter), and/or history or presence of thyroid storm.

2. History of treatment with radioactive iodine ablation or thyroidectomy.

3. Total immunoglobulin G (IgG) level <6 grams per liter (g/L) at the Screening Visit.

4. Albumin level <3.5 grams per deciliter (g/dL) (<35 g/L) at the Screening Visit.

5. Absolute neutrophil count <1000 cells per cubic millimeter (cells/mm^3) at the Screening Visit.

Other, more specific exclusion criteria are defined in the protocol.