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Trial record 1 of 4 for:    batoclimab | Graves Disease
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A Proof-of-Concept Study to Assess Batoclimab in Participants With Graves' Disease

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ClinicalTrials.gov Identifier: NCT05907668
Recruitment Status : Recruiting
First Posted : June 18, 2023
Last Update Posted : September 5, 2023
Sponsor:
Information provided by (Responsible Party):
Immunovant Sciences GmbH

Study Description
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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).

Condition or disease Intervention/treatment Phase
Graves Disease Drug: IMVT-1401 (batoclimab) Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : November 2024
Estimated Study Completion Date : May 2025

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Arms and Interventions
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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 Name: IMVT-1401


Outcome Measures
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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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: At Week 24 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05907668


Contacts
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Contact: Central Study Contact 18007970414 clinicaltrials@immunovant.com

Locations
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Germany
Site Number - 6505 Recruiting
Mainz, Germany, 55131
Sponsors and Collaborators
Immunovant Sciences GmbH
More Information
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Responsible Party: Immunovant Sciences GmbH
ClinicalTrials.gov Identifier: NCT05907668    
Other Study ID Numbers: IMVT-1401-2501
First Posted: June 18, 2023    Key Record Dates
Last Update Posted: September 5, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Graves Disease
Exophthalmos
Orbital Diseases
Eye Diseases
Goiter
 Thyroid Diseases
Endocrine System Diseases
Hyperthyroidism
Autoimmune Diseases
Immune System Diseases