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A Proof-of-Concept Study to Assess Batoclimab in Participants With Graves' Disease | Clinical Trials | Clareo Health

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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)

NCT05907668•Immunovant Sciences GmbH

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Site Number - 6505

Mainz, Germany

Key Dates

Start Date

May 15, 2023

Primary Completion Date

July 25, 2025

Completion Date

July 25, 2025

Last Updated

February 2, 2026

Enrollment

ACTUAL participants

Conditions

Graves Disease

Interventions

IMVT-1401 (batoclimab)

DRUG

Personalized Treatment in Thyroid Disorders

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 2, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Personalized Treatment in Thyroid Disorders

Rubus Sanctus (Wild Blackberry) Root Extract as a Dietary Supplement for Graves' Disease

Prevalence and Predictors of Incidental Thyroid Carcinoma in Patients With Graves' Disease Undergoing Thyroidectomy.

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Graves' Disease Induced by Epstein-Barr Virus Lytic Reactivation

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