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

Primary Purpose

Graves Disease

Status
Recruiting
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
IMVT-1401 (batoclimab)
Sponsored by
Immunovant Sciences GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Graves Disease focused on measuring Graves' Disease, IMVT-1401, Batoclimab, Hyperthyroidism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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. Other, more specific exclusion criteria are defined in the protocol.

Sites / Locations

  • Site Number - 6505Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Batoclimab

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Percentage of participants who achieve normalization of FT3 and FT4 at Week 24 with ATD dose <= 50% of the ATD dose 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

Full Information

First Posted
May 15, 2023
Last Updated
August 31, 2023
Sponsor
Immunovant Sciences GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT05907668
Brief Title
A Proof-of-Concept Study to Assess Batoclimab in Participants With Graves' Disease
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2023 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Immunovant Sciences GmbH

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graves Disease
Keywords
Graves' Disease, IMVT-1401, Batoclimab, Hyperthyroidism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Batoclimab
Arm Type
Experimental
Arm Description
Participants will receive batoclimab 680 milligrams (mg) subcutaneously (SC) weekly (QW) injection for 12 weeks followed by 340 mg SC QW for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
IMVT-1401 (batoclimab)
Other Intervention Name(s)
IMVT-1401
Intervention Description
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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. Other, more specific exclusion criteria are defined in the protocol.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Central Study Contact
Phone
18007970414
Email
clinicaltrials@immunovant.com
Facility Information:
Facility Name
Site Number - 6505
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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