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ACTIVE NOT RECRUITING
NCT05517447
PHASE3

Extension Study to Assess Batoclimab in Participants With Thyroid Eye Disease

Sponsor: Immunovant Sciences GmbH

View on ClinicalTrials.gov

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.

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

180

Start Date

2022-11-06

Completion Date

2026-08

Last Updated

2026-02-18

Healthy Volunteers

No

Interventions

OTHER

Observational cohort study

Observational cohort study

DRUG

Batoclimab

Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody

Locations (55)

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