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NCT05517447 · ClinicalTrials.gov registry record · Phase 3
Extension Study to Assess Batoclimab in Participants With Thyroid Eye Disease
A Phase 3 study of Thyroid Eye Disease, sponsored by Immunovant Sciences.
- Active
- Registry status
- Phase 3
- Development phase
- 180
- Enrollment target
- 20
- Study locations
NCT05517447 is a Phase 3 study of Thyroid Eye Disease that is active but no longer recruiting, run by Immunovant Sciences. The registered enrollment target is 180 participants, above the 94-participant average among 15 other Thyroid Eye Disease trials with a reported enrollment target (91% higher). The trial reports 20 study locations across 9 states.
The verdict
NCT05517447, a Phase 3 study of Thyroid Eye Disease, is active but no longer recruiting, sponsored by Immunovant Sciences.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 180 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- OTHER Observational cohort study
- DRUG Batoclimab
Study Locations (20)
Other
- Site Number - 7565 - Sydney
- Site Number - 4671 - Bruges
- Site Number - 4672 - Brussels
- Site Number - 4673 - Brussels
- Site Number - 4670 - Ghent
- Site Number - 3454 - Tbilisi
- Site Number - 3455 - Tbilisi
- Site Number - 3450 - Tbilisi
- Site Number - 3451 - Tbilisi
- Site Number - 7550 - Budapest
- Site Number - 7552 - Pécs
Texas
- Site Number - 1508 - Houston
- Site Number - 1558 - Mesquite
California
- Site Number - 1520 - Glendora
Colorado
- Site Number - 1501 - Aurora
Michigan
- Site Number - 1526 - Livonia
Minnesota
- Site Number - 1513 - Rochester
Nevada
- Site Number - 1540 - Las Vegas
West Virginia
- Site Number - 1511 - Morgantown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2022-11-06 |
| Est. Completion | 2026-08 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05517447
The ClinicalTrials.gov registry entry for NCT05517447 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 94-participant average among 15 other Thyroid Eye Disease trials with a reported enrollment target (91% higher). The listed sponsor is Immunovant Sciences, which has 15 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Thyroid Eye Disease appearing as the primary indexed condition, and to 2 interventions - of which Observational cohort study is the first listed.
NCT05517447 reports 20 study locations spanning 9 distinct geographic areas - top geographies include Other, Texas, California.
Frequently Asked Questions
What is clinical trial NCT05517447 about?
NCT05517447 is a clinical study titled "Extension Study to Assess Batoclimab in Participants With Thyroid Eye Disease". 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 eff...
What is the current status of trial NCT05517447?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 180 participants. The study started on 2022-11-06. Estimated completion is 2026-08.
What conditions does trial NCT05517447 study?
This clinical trial studies the following conditions: Thyroid Eye Disease.
What interventions are being tested in trial NCT05517447?
The interventions under investigation include: Observational cohort study (OTHER), Batoclimab (DRUG).
Who is sponsoring clinical trial NCT05517447?
This trial is sponsored by Immunovant Sciences, which has 15 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05517447 being conducted?
This trial has 20 study locations across California, Colorado, Michigan, Minnesota, Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Read our methodology - how this data is sourced, computed, and verified.
Related
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