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

August 31, 2023 updated by: Immunovant Sciences GmbH

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Mainz, Germany, 55131
        • Recruiting
        • Site Number - 6505

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: IMVT-1401 (batoclimab)
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody.
Other Names:
  • IMVT-1401

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: At Week 24
At Week 24

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of participants who achieve normalization of FT3 and FT4 at Week 24 with ATD dose <= 50% of the ATD dose at Week 24
Time Frame: At Week 24
At Week 24
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
Time Frame: At Week 24
At Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Immunovant Sciences GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2023

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

May 15, 2023

First Submitted That Met QC Criteria

June 7, 2023

First Posted (Actual)

June 18, 2023

Study Record Updates

Last Update Posted (Actual)

September 5, 2023

Last Update Submitted That Met QC Criteria

August 31, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMVT-1401-2501

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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