Extension Study to Assess Batoclimab in Participants With Thyroid Eye Disease

NCT05517447 | Terminated Phase 3 DMC FDA Drug

• 1 other identifier: IMVT-1401-3203
• Study Type: interventional
• Target: 109
• Locations: 14 countries
• Sites: 55

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.

Conditions

Thyroid Eye Disease

Keywords

Batoclimab; Thyroid eye disease; IMVT-1401; Monoclonal antibody; Autoimmune disorders; Graves' Ophthalmopathy; Graves' Orbitopathy

Outcome Measures

Primary Outcomes (1)

• Duration of proptosis response off treatment in study eye in batoclimab responder participants in the feeder studies

  Up to Week 24

Secondary Outcomes (2)

• 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

Study Arms (2)

Observational cohort

OTHER

Proptosis responders in feeder studies will enter in a non-treatment observational study

Other: Observational cohort study

Treatment Cohort

EXPERIMENTAL

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

Drug: Batoclimab

Interventions

Batoclimab DRUG

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

Also known as: IMVT-1401

Treatment Cohort

Observational cohort study OTHER

Observational cohort study

Observational cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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.

Sponsors & Collaborators

• Immunovant Sciences GmbH: lead

Study Sites (55)

Site Number - 1520

Glendora, California, 91741, United States

Location

Site Number - 1501

Aurora, Colorado, 80045, United States

Location

Site Number - 1526

Livonia, Michigan, 48152, United States

Location

Site Number - 1513

Rochester, Minnesota, 55905, United States

Location

Site Number - 1540

Las Vegas, Nevada, 89184, United States

Location

Site Number - 1508

Houston, Texas, 77030, United States

Location

Site Number - 1558

Mesquite, Texas, 75149, United States

Location

Site Number - 1511

Morgantown, West Virginia, 26506, United States

Location

Site Number - 1518

Milwaukee, Wisconsin, 53226, United States

Location

Site Number - 7565

Sydney, 2000, Australia

Location

Site Number - 4671

Bruges, 8000, Belgium

Location

Site Number - 4672

Brussels, 1070, Belgium

Location

Site Number - 4673

Brussels, 1200, Belgium

Location

Site Number - 4670

Ghent, B-9000, Belgium

Location

Site Number - 3454

Tbilisi, 114, Georgia

Location

Site Number - 3455

Tbilisi, 114, Georgia

Location

Site Number - 3450

Tbilisi, 159, Georgia

Location

Site Number - 3451

Tbilisi, 159, Georgia

Location

Site Number - 7550

Budapest, 1133, Hungary

Location

Site Number - 7552

Pécs, 7623, Hungary

Location

Site Number - 4760

Ramat Gan, Tel Aviv, 5265601, Israel

Location

Site Number - 4764

Afula, 1834111, Israel

Location

Site Number - 4761

Jerusalem, 91120, Israel

Location

Site Number - 4762

Petah Tikva, 4941492, Israel

Location

Site Number - 6207

Catania, CAP95125, Italy

Location

Site Number - 6204

Milan, 20122, Italy

Location

Site Number - 6203

Milan, 20149, Italy

Location

Site Number - 6205

Naples, 80131, Italy

Location

Site Number - 6209

Palermo, 90127, Italy

Location

Site Number - 6201

Pisa, 56124, Italy

Location

Site Number - 6202

Rome, 00189, Italy

Location

Site Number - 9301

Ogre, LV-5001, Latvia

Location

Site Number - 9300

Riga, LV-1006, Latvia

Location

Site Number - 9302

Ventspils, LV3601, Latvia

Location

Site Number - 7570

Christchurch, 8013, New Zealand

Location

Site Number - 3107

Gliwice, Silesian Voivodeship, 44-102, Poland

Location

Site Number - 3101

Krakow, 30-688, Poland

Location

Site Number - 3104

Lublin, 20-171, Poland

Location

Site Number - 3105

Lublin, 60-354, Poland

Location

Site Number - 1990

San Juan, 00921, Puerto Rico

Location

Site Number - 9200

Bratislava, 82606, Slovakia

Location

Site Number - 9201

Bratislava, Slovakia

Location

Site Number - 9202

Trenčín, 91101, Slovakia

Location

Site Number - 3602

Barcelona, Catalonia, 8006, Spain

Location

Site Number - 3604

Madrid, 28034, Spain

Location

Site Number - 3600

Santiago de Compostela, 15706, Spain

Location

Site Number - 3606

Seville, 41009, Spain

Location

Site Number - 3603

Valencia, 46026, Spain

Location

Site Number - 7305

Guildford, GU2 7XX, United Kingdom

Location

Site Number - 7303

London, EC1V 2PD, United Kingdom

Location

Site Number - 7312

London, W1T 6AH, United Kingdom

Location

Site Number - 7313

London, W1T 7HA, United Kingdom

Location

Site Number - 7300

Manchester, M139WL, United Kingdom

Location

Site Number - 7302

Newcastle upon Tyne, NE1 3BZ, United Kingdom

Location

Site Number - 7308

Sheffield, S102SB, United Kingdom

Location

MeSH Terms

Conditions

Graves Ophthalmopathy; Autoimmune Diseases

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Graves Disease; Exophthalmos; Orbital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: August 26, 2022
• Study Start: November 6, 2022
• Primary Completion: April 2, 2026
• Study Completion: April 2, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

LA (3); HU (2); IL (4); AU (1); IT (7); GE (4); PL (4); US (9); SL (3); NZ (1); ES (5); GB (7); PR (1); BE (4)