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

Graves Disease Clinical Trial

Official title:

IMVT-1401-2501: A Proof-of-Concept, Open-label Study to Assess the Safety and Efficacy of Batoclimab in Participants With Graves' Disease (GD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05907668
• Other study ID #: IMVT-1401-2501
• Status: Recruiting
• Phase: Phase 2
• Start date: May 15, 2023
• Est. completion date: May 2025

Study information

• Verified date: September 2023
• Source: Immunovant Sciences GmbH
• Contact: Central Study Contact
• Phone: 18007970414
• Email: clinicaltrials[@]immunovant.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: May 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Graves Disease

Intervention

Drug:
• IMVT-1401 (batoclimab)
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody.

Locations

Country	Name	City	State
Germany	Site Number - 6505	Mainz

Sponsors (1)

Lead Sponsor	Collaborator
Immunovant Sciences GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants who achieve normalization of free triiodothyronine (FT3) and free thyroxine (FT4), or have FT3 and/or FT4 below the lower limit of normal (LLN) at week 24 without increase in ATD dose		At Week 24
Secondary	Percentage of participants who achieve normalization of FT3 and FT4 at Week 24 with ATD dose <= 50% of the ATD dose at Week 24		At Week 24
Secondary	Percentage of participants who are off ATD treatment and achieve normalization of FT3 and FT4, or have FT3 and/or FT4 below the LLN at Week 24		At Week 24