Extension Study to Assess Batoclimab in Participants With Thyroid Eye Disease
Stopped early · Phase 3
Conditions studied: Thyroid Eye Disease
In brief
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.
Key facts
- Study ID
- NCT05517447
- Run by
- Immunovant Sciences GmbH
- People needed
- 109
- Starts
- 2022-11-06
- Expected to finish
- 2026-04-02
- Last updated by the study team
- 2026-04-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- For all participants:
- 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.
You may not qualify if…
- For all participants:
- In the Investigator's judgement, the benefits of entry in the study do not outweigh the risk.
Where it is running
- Site Number - 1520 — Glendora, California, United States
- Site Number - 1501 — Aurora, Colorado, United States
- Site Number - 1526 — Livonia, Michigan, United States
- Site Number - 1513 — Rochester, Minnesota, United States
- Site Number - 1540 — Las Vegas, Nevada, United States
- Site Number - 1508 — Houston, Texas, United States
- Site Number - 1558 — Mesquite, Texas, United States
- Site Number - 1511 — Morgantown, West Virginia, United States
- Site Number - 1518 — Milwaukee, Wisconsin, United States
- Site Number - 7565 — Sydney, Australia
- Site Number - 4671 — Bruges, Belgium
- Site Number - 4672 — Brussels, Belgium
- Site Number - 4673 — Brussels, Belgium
- Site Number - 4670 — Ghent, Belgium
- Site Number - 3454 — Tbilisi, Georgia
- Site Number - 3455 — Tbilisi, Georgia
- Site Number - 3450 — Tbilisi, Georgia
- Site Number - 3451 — Tbilisi, Georgia
- Site Number - 7550 — Budapest, Hungary
- Site Number - 7552 — Pécs, Hungary
- Site Number - 4760 — Ramat Gan, Tel Aviv, Israel
- Site Number - 4764 — Afula, Israel
- Site Number - 4761 — Jerusalem, Israel
- Site Number - 4762 — Petah Tikva, Israel
- Site Number - 3603 — Valencia, Spain
Full record on ClinicalTrials.gov
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