Extension Study to Assess Batoclimab in Participants With Thyroid Eye Disease

Phase 3

Recruiting

• Conditions: Thyroid Eye Disease
• Interventions: Other: Observational cohort study; Drug: Batoclimab

• Registration Number: NCT05517447
• Lead Sponsor: Immunovant Sciences GmbH

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-24
• Study First Submitted QC: 2022-08-24
• Study First Posted: 2022-08-26
• Study Start: 2022-11-06
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-18
• Last Update Posted: 2024-12-19
• Primary Completion: 2026-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Observational cohort	Observational cohort study	Proptosis responders in feeder studies will enter in a non-treatment observational study
Treatment Cohort	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

Primary Outcome Measures

Name	Time	Method
Duration of proptosis response off treatment in study eye in batoclimab responder participants in the feeder studies	Up to Week 24

Secondary Outcome Measures

Name	Time	Method
Percentage of proptosis responders in study eye in placebo non-responder participants in the feeder studies	At Week 24
Percentage of proptosis responders in study eye in batoclimab non-responder participants in the feeder studies	At Week 24

Trial Locations

Locations (37)

Site Number - 9302; 🇱🇻 Ventspils, Latvia

Site Number - 1990; 🇵🇷 San Juan, Puerto Rico

Site Number - 9200; 🇸🇰 Bratislava, Slovakia

Site Number - 9201; 🇸🇰 Bratislava, Slovakia

Site Number - 3602; 🇪🇸 Barcelona, Catalonia, Spain

Site Number - 3604; 🇪🇸 Madrid, Spain

Site Number - 3600; 🇪🇸 Santiago De Compostela, Spain

Site Number - 3606; 🇪🇸 Sevilla, Spain

Site Number - 3603; 🇪🇸 Valencia, Spain

Site Number - 7305; 🇬🇧 Guildford, United Kingdom

Site Number - 7308; 🇬🇧 Sheffield, United Kingdom

Site Number - 1540; 🇺🇸 Las Vegas, Nevada, United States

Site Number - 1518; 🇺🇸 Milwaukee, Wisconsin, United States

Site Number - 3454; 🇬🇪 Tbilisi, Georgia

Site Number - 3450; 🇬🇪 Tbilisi, Georgia

Site Number - 7570; 🇳🇿 Christchurch, New Zealand

Site Number - 3101; 🇵🇱 Kraków, Poland

Site Number - 3104; 🇵🇱 Lublin, Poland

Site Number - 9202; 🇸🇰 Trenčín, Slovakia

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 - 1511; 🇺🇸 Morgantown, West Virginia, United States

Site Number - 4671; 🇧🇪 Brugge, Belgium

Site Number - 4672; 🇧🇪 Bruxelles, Belgium

Site Number - 4673; 🇧🇪 Bruxelles, Belgium

Site Number - 4670; 🇧🇪 Gent, Belgium

Site Number - 7550; 🇭🇺 Budapest, Hungary

Site Number - 7552; 🇭🇺 Pécs, Hungary

Site Number - 4760; 🇮🇱 Ramat Gan, Tel Aviv, Israel

Site Number - 4761; 🇮🇱 Jerusalem, Israel

Site Number - 4762; 🇮🇱 Petah tikva, Israel

Site Number - 6205; 🇮🇹 Napoli, Italy

Site Number - 6202; 🇮🇹 Rome, Italy

Site Number - 9301; 🇱🇻 Ogre, Latvia

Site Number - 9300; 🇱🇻 Riga, Latvia