Back to resultsExtension Study to Assess Batoclimab in Participants With Thyroid Eye Disease
Primary Purpose
Thyroid Eye Disease
Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Observational cohort study
Batoclimab
Sponsored by
About this trial
This is an interventional treatment trial for Thyroid Eye Disease focused on measuring Batoclimab, Thyroid eye disease, IMVT-1401, Monoclonal antibody, Autoimmune disorders, Graves' Ophthalmopathy, Graves' Orbitopathy
Eligibility 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:
- Do not require immediate surgical intervention and is not planning corrective surgery/irradiation or medical therapy for TED during the course of the study.
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Observational cohort
Treatment Cohort
Arm Description
Proptosis responders in feeder studies will enter in a non-treatment observational study
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
Outcomes
Primary Outcome Measures
Duration of proptosis response off treatment in study eye in batoclimab responder participants in the feeder studies
Secondary Outcome Measures
Percentage of proptosis responders in study eye in placebo non-responder participants in the feeder studies
Percentage of proptosis responders in study eye in batoclimab non-responder participants in the feeder studies
Full Information
NCT ID
NCT05517447
First Posted
August 24, 2022
Last Updated
September 6, 2023
Sponsor
Immunovant Sciences GmbH
1. Study Identification
Unique Protocol Identification Number
NCT05517447
Brief Title
Extension Study to Assess Batoclimab in Participants With Thyroid Eye Disease
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)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
June 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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Eye Disease
Keywords
Batoclimab, Thyroid eye disease, IMVT-1401, Monoclonal antibody, Autoimmune disorders, Graves' Ophthalmopathy, Graves' Orbitopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Observational cohort
Arm Type
Other
Arm Description
Proptosis responders in feeder studies will enter in a non-treatment observational study
Arm Title
Treatment Cohort
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Observational cohort study
Intervention Description
Observational cohort study
Intervention Type
Drug
Intervention Name(s)
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
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 Measure Information:
Title
Percentage of proptosis responders in study eye in placebo non-responder participants in the feeder studies
Time Frame
At Week 24
Title
Percentage of proptosis responders in study eye in batoclimab non-responder participants in the feeder studies
Time Frame
At Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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:
Do not require immediate surgical intervention and is not planning corrective surgery/irradiation or medical therapy for TED during the course of the study.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Central Study Contact
Phone
18007970414
Email
clinicaltrials@immunovant.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Extension Study to Assess Batoclimab in Participants With Thyroid Eye Disease
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