A Proof-of-Concept Study to Assess Batoclimab in Participants With Graves' Disease

NCT ID: NCT05907668

Last Updated: 2026-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-15
• Study Completion Date: 2025-07-25

Brief 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

Graves Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Batoclimab

Participants will receive batoclimab 680 milligrams (mg) subcutaneously (SC) weekly (QW) injection for 12 weeks followed by 340 mg SC QW for 12 weeks.

Group Type: EXPERIMENTAL

IMVT-1401 (batoclimab)

Intervention Type: DRUG

Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody.

Interventions

IMVT-1401 (batoclimab)

Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody.

Intervention Type: DRUG

Other Intervention Names

IMVT-1401

Eligibility Criteria

Inclusion Criteria

• 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.
• Have active hyperthyroidism due to GD 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

Note: Participants who have T3 thyrotoxicosis (i.e TSH <LLN, FT3 > ULN and ≤5× ULN, but FT4 within normal range) at the Screening Visit may be enrolled, if they have serologically confirmed GD as per Inclusion Criterion 1.

• 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.

Exclusion Criteria

• History of hyperthyroidism not caused by GD (e.g., toxic adenoma or toxic multinodular goiter), and/or history or presence of thyroid storm.
• History of treatment with radioactive iodine or thyroid surgery.
• Total immunoglobulin G (IgG) level <6 grams per liter (g/L) at the Screening Visit.
• Albumin level <3.5 grams per deciliter (g/dL) (<35 g/L) at the Screening Visit.
• Absolute neutrophil count <1000 cells per cubic millimeter (cells/mm^3) at the Screening Visit.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Immunovant Sciences GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Site Number - 6505

Mainz, , Germany

Countries

Germany

Other Identifiers

IMVT-1401-2501

Identifier Type: -

Identifier Source: org_study_id