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Study to Evaluate the Safety and Efficacy of Batoclimab in Participants With Graves' Disease (GD)

Sponsor
Immunovant Sciences GmbH (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05907668
Collaborator
(none)
45
Enrollment
1
Location
1
Arm
23.6
Anticipated Duration (Months)
1.9
Patients Per Site Per Month

Study Details

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 with antithyroid drugs (ATDs).

Condition or Disease Intervention/Treatment Phase
  • Drug: IMVT-1401 (batoclimab)
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
May 15, 2023
Anticipated Primary Completion Date :
Nov 1, 2024
Anticipated Study Completion Date :
May 1, 2025

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. 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]

    2. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. 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.

    2. Have inadequate response to ADT treatment 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

    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.

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

    Exclusion Criteria:

    1. History of hyperthyroidism not caused by GD (e.g., toxic adenoma or toxic multinodular goiter), and/or history or presence of thyroid storm.

    2. History of treatment with radioactive iodine ablation or thyroidectomy.

    3. Total immunoglobulin G (IgG) level <6 grams per liter (g/L) at the Screening Visit.

    4. Albumin level <3.5 grams per deciliter (g/dL) (<35 g/L) at the Screening Visit.

    5. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Site Number - 6505 Mainz Germany 55131

    Sponsors and Collaborators

    • Immunovant Sciences GmbH

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Immunovant Sciences GmbH
    ClinicalTrials.gov Identifier:
    NCT05907668
    Other Study ID Numbers:
    • IMVT-1401-2501
    First Posted:
    Jun 18, 2023
    Last Update Posted:
    Jun 18, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Immunovant Sciences GmbH
    Graves' Disease
    IMVT-1401
    Batoclimab
    Hyperthyroidism
    Additional relevant MeSH terms:
    Graves Disease

    Study Results

    No Results Posted as of Jun 18, 2023