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Trial record 2 of 4 for:    batoclimab | Graves Disease
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Extension Study to Assess Batoclimab in Participants With Thyroid Eye Disease

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ClinicalTrials.gov Identifier: NCT05517447
Recruitment Status : Recruiting
First Posted : August 26, 2022
Last Update Posted : April 22, 2024
Sponsor:
Information provided by (Responsible Party):
Immunovant Sciences GmbH

Study Description
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Brief Summary:
This is a 2-cohort (observational and treatment cohort) extension study for participants completing feeder studies (IMVT-1401-3201 or IMVT-1401-3202). The observational cohort will assess the durability of proptosis response of feeder studies off treatment. The treatment cohort will evaluate the efficacy of batoclimab as assessed by proptosis responder rate.

Condition or disease Intervention/treatment Phase
Thyroid Eye Disease Other: Observational cohort study Drug: Batoclimab Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Extension Study for Participants Who Completed Study IMVT-1401-3201 or Study IMVT-1401-3202 to Assess the Efficacy and Safety of Batoclimab for the Treatment of Thyroid Eye Disease (TED)
Actual Study Start Date : November 6, 2023
Estimated Primary Completion Date : May 2025
Estimated Study Completion Date : June 2025

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Arms and Interventions
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Arm Intervention/treatment
Observational cohort
Proptosis responders in feeder studies will enter in a non-treatment observational study
 Other: Observational cohort study
Observational cohort study
Experimental: Treatment Cohort
Proptosis non-responders in feeder studies will be administered batoclimab of 680 milligram (mg) subcutaneous (SC) for 12 weeks followed by 340 mg SC for 12 weeks
 Drug: 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. Duration of proptosis response off treatment in study eye in batoclimab responder participants in the feeder studies [ Time Frame: Up to Week 24 ]

Secondary Outcome Measures :
  1. Percentage of proptosis responders in study eye in placebo non-responder participants in the feeder studies [ Time Frame: At Week 24 ]
  2. Percentage of proptosis responders in study eye in batoclimab non-responder participants in the feeder studies [ 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:

For all participants:

1. Have completed the Week 24 visit of the feeder study.

For participants assigned to the Open-label Treatment Cohort:

  1. Do not require immediate surgical intervention and is not planning corrective surgery/irradiation or medical therapy for TED during the course of the study.
  2. Did not permanently discontinue batoclimab

Additional inclusion criteria are defined in the protocol.

Exclusion criteria:

For all participants:

1. In the Investigator's judgement, the benefits of entry in the study do not outweigh the risk.

Contacts and Locations
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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): NCT05517447


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

Locations
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United States, California
Site Number - 1520 Recruiting
Glendora, California, United States, 91741
United States, Minnesota
Site Number - 1513 Recruiting
Rochester, Minnesota, United States, 55905
Belgium
Site Number - 4671 Recruiting
Brugge, Belgium, 8000
Site Number - 4670 Recruiting
Gent, Belgium, B-9000
Hungary
Site Number - 7550 Recruiting
Budapest, Hungary, 1133
Latvia
Site Number - 9301 Recruiting
Ogre, Latvia, LV-5001
Site Number - 9302 Recruiting
Ventspils, Latvia, LV3601
Spain
Site Number - 3602 Recruiting
Barcelona, Catalonia, Spain, 8006
Site Number - 3606 Recruiting
Sevilla, Spain, 41009
Site Number - 3603 Recruiting
Valencia, Spain, 46026
Sponsors and Collaborators
Immunovant Sciences GmbH
More Information
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Responsible Party: Immunovant Sciences GmbH
ClinicalTrials.gov Identifier: NCT05517447    
Other Study ID Numbers: IMVT-1401-3203
First Posted: August 26, 2022    Key Record Dates
Last Update Posted: April 22, 2024
Last Verified: April 2024
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
Keywords provided by Immunovant Sciences GmbH:
Batoclimab
Thyroid eye disease
IMVT-1401
Monoclonal antibody
 Autoimmune disorders
Graves' Ophthalmopathy
Graves' Orbitopathy
Additional relevant MeSH terms:
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Eye Diseases
Graves Ophthalmopathy
Thyroid Diseases
Endocrine System Diseases
Eye Diseases, Hereditary
Graves Disease
Orbital Diseases
 Genetic Diseases, Inborn
Autoimmune Diseases
Immune System Diseases
Exophthalmos
Goiter
Hyperthyroidism