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)
| Registry | NCT05517447 |
|---|---|
| Status | Terminated - The feeder studies (i.e., IMVT-1401-3201 and 3202) for study IMVT-1401-3203 failed to achieve their pre-defined primary efficacy outcomes. Accordingly, there was a change to the benefit-risk balance. No new safety findings were observed. |
| Phase | Phase 3 |
| Study type | Interventional; non randomized, parallel, masking: none, treatment |
| Enrollment | 109 (Actual) |
| Sponsor | Immunovant Sciences GmbH (Industry) |
| Conditions | Thyroid Eye Disease |
| Interventions | Observational cohort study, Batoclimab (Other, drug) |
| Dates | start 2022-11-06, primary completion 2026-04-02, completion 2026-04-02, first posted 2022-08-26, last updated 2026-04-29 |
| Locations | 55 sites in United States, Australia, Belgium, Georgia, Hungary, Israel, Italy, Latvia and 6 more countries |
Related Papers Related Patents Related Grants Related Experts
All trials for Thyroid Eye Disease All trials of Observational cohort study All trials of Batoclimab
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Observational cohort | Other | Other: Observational cohort study | Proptosis responders in feeder studies will enter in a non-treatment observational study |
| Treatment Cohort | Experimental | Drug: Batoclimab | 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 |
Sex: All, ages: 18 Years to any
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.
| Facility | City | Country | Status |
|---|---|---|---|
| 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 - 6207 | Catania | Italy | |
| Site Number - 6204 | Milan | Italy | |
| Site Number - 6203 | Milan | Italy | |
| Site Number - 6205 | Naples | Italy | |
| Site Number - 6209 | Palermo | Italy | |
| Site Number - 6201 | Pisa | Italy | |
| Site Number - 6202 | Rome | Italy | |
| Site Number - 9301 | Ogre | Latvia | |
| Site Number - 9300 | Riga | Latvia | |
| Site Number - 9302 | Ventspils | Latvia | |
| Site Number - 7570 | Christchurch | New Zealand | |
| Site Number - 3107 | Gliwice, Silesian Voivodeship | Poland | |
| Site Number - 3101 | Krakow | Poland | |
| Site Number - 3104 | Lublin | Poland | |
| Site Number - 3105 | Lublin | Poland | |
| Site Number - 1990 | San Juan | Puerto Rico | |
| Site Number - 9200 | Bratislava | Slovakia | |
| Site Number - 9201 | Bratislava | Slovakia | |
| Site Number - 9202 | Trenčín | Slovakia | |
| Site Number - 3602 | Barcelona, Catalonia | Spain | |
| Site Number - 3604 | Madrid | Spain | |
| Site Number - 3600 | Santiago de Compostela | Spain | |
| Site Number - 3606 | Seville | Spain | |
| Site Number - 3603 | Valencia | Spain | |
| Site Number - 7305 | Guildford | United Kingdom | |
| Site Number - 7303 | London | United Kingdom | |
| Site Number - 7312 | London | United Kingdom | |
| Site Number - 7313 | London | United Kingdom | |
| Site Number - 7300 | Manchester | United Kingdom | |
| Site Number - 7302 | Newcastle upon Tyne | United Kingdom | |
| Site Number - 7308 | Sheffield | United Kingdom |