Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease

NCT05524571 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: IMVT-1401-3202
• Study Type: interventional
• Target: 86
• Locations: 11 countries
• Sites: 45

Brief Summary

To evaluate the efficacy of batoclimab 680 milligrams (mg) subcutaneous (SC) once a week (QW) for 12 weeks followed by 340 mg SC QW for 12 weeks versus placebo on proptosis responder rate at Week 24.

Conditions

Thyroid Eye Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Percentage of proptosis responders

  Proptosis is the amount of protrusion of the eye from the orbital rim. Measurements are recorded using the Hertel exophthalmometer. The study eye is defined as the most severely affected eye at the Baseline visit. Proptosis responder is defined as the participant with a greater than or equal to (≥) 2 millimeters (mm) reduction in the study eye without deterioration (≥2 mm increase) in the fellow eye.

  At Week 24

Secondary Outcomes (8)

• Percentage of participants with proptosis ≥2 mm reduction and Clinical Activity Score (CAS) of less than or equal to (≤) 3 from Baseline in the study eye

  Baseline and Week 24

• Percentage of participants with CAS of 0 or 1 in the study eye

  At Week 24

• Mean change from Baseline in CAS in the study eye

  Baseline and Week 24

• Percentage of participants with positive binding anti-thyroid stimulating hormone receptor (TSHR) antibody (Ab) at Baseline who achieve seroconversion

  Baseline and Week 24

• Percentage of participants with decrease of at least 1 grade from Baseline in Gorman score for diplopia

  Baseline and Week 24

Study Arms (2)

Batoclimab

EXPERIMENTAL

Participants will be administered batoclimab 680 mg SC weekly for 12 weeks followed by 340 mg SC weekly for 12 weeks.

Drug: Batoclimab

Placebo

PLACEBO COMPARATOR

Participants will be administered matching placebo SC weekly for 24 weeks.

Drug: Placebo

Interventions

Placebo DRUG

Matching Placebo

Placebo

Batoclimab DRUG

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

Also known as: IMVT-1401

Batoclimab

Eligibility Criteria

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

You may qualify if:

• Are ≥18 years of age at screening.
• Have a clinical diagnosis of TED associated with active, moderate to severe TED with the following at screening and Visit 0:
• A CAS ≥ 4 in either eye, and
• Clinical evidence of worsened proptosis with:
• Proptosis ≥ 18 mm and/or
• Proptosis ≥ 3 mm increase from participant's baseline (prior to diagnosis of TED), as estimated by the Investigator/assessor
• Have moderate to severe active TED, as defined by European Group on Graves' Orbitopathy (EUGOGO) guidelines.
• Have onset of active TED within 12 months prior to screening.
• Have documented evidence of detectable anti-TSHR-Ab at screening.
• Are not expected to require immediate surgical intervention and are not planning corrective surgery/irradiation or medical therapy for TED during the course of the study.
• Are euthyroid with the Baseline disease under control or have mild hypo- or hyperthyroidism.

You may not qualify if:

• Have decreased best corrected visual acuity due to optic neuropathy.
• Have at least a 2-point decrease in CAS or ≥2 mm decrease in proptosis between screening and Baseline assessments in either eye.
• Have used any steroid (intravenous or oral) for the treatment of TED or other conditions within 4 weeks prior to screening.
• Have used any steroid (Intravenous or oral) with a cumulative dose equivalent to ≥ 1 g of methylprednisolone for the treatment of TED.
• Have known autoimmune disease other than TED, that, in the opinion of the Investigator, would interfere with the course and conduct of the study.
• Had previous orbital irradiation or surgery for TED.

Sponsors & Collaborators

• Immunovant Sciences GmbH: lead

Study Sites (45)

Site Number -1520

Pasadena, California, 91107, United States

Location

Site Number -1517

San Francisco, California, 94143, United States

Location

Site Number -1514

Torrance, California, 90502, United States

Location

Site Number -1510

Sarasota, Florida, 34239, United States

Location

Site Number -1516

Louisville, Kentucky, 40202, United States

Location

Site Number - 1526

Livonia, Michigan, 48152, United States

Location

Site Number - 1513

Rochester, Minnesota, 55905, United States

Location

Site Number - 1512

Winston-Salem, North Carolina, 27157, United States

Location

Site Number - 1525

Portland, Oregon, 97239, United States

Location

Site Number -1515

Bellaire, Texas, 77401, United States

Location

Site Number - 1524

McAllen, Texas, 78503, United States

Location

Site Number -1519

San Antonio, Texas, 78215, United States

Location

Site Number - 1521

Seattle, Washington, 98104, 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 - 4674

Liège, 4000, Belgium

Location

Site Number - 6603

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Site Number - 7550

Budapest, 1133, Hungary

Location

Site Number - 7551

Pécs, 7621, Hungary

Location

Site Number - 7552

Pécs, 7623, Hungary

Location

Site Number -9301

Ogre, LV-5001, Latvia

Location

Site Number -9300

Riga, LV-1006, Latvia

Location

Site Number - 9302

Ventspils, LV-3601, Latvia

Location

Site Number - 7570

Christchurch, 8013, New Zealand

Location

Site Number - 7572

Hamilton, 3204, New Zealand

Location

Site Number -1990

San Juan, 00921, Puerto Rico

Location

Site Number - 9203

Bratislava, 81108, Slovakia

Location

Site Number - 9200

Bratislava, 82606, Slovakia

Location

Site Number - 9201

Bratislava, 85107, Slovakia

Location

Site Number - 9202

Trenčín, 91101, Slovakia

Location

Site Number -3602

Barcelona, 08006, Spain

Location

Site Number - 3605

Barcelona, 08035, Spain

Location

Site Number -3601

Madrid, 28007, 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 - 4952

Adana, 13860, Turkey (Türkiye)

Location

Site Number - 4950

Ankara, 6100, Turkey (Türkiye)

Location

Site Number - 4951

Istanbul, 34010, Turkey (Türkiye)

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: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor Staff is also masked, so the study is Quadruple-blind.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: September 1, 2022
• Study Start: January 5, 2023
• Primary Completion: February 3, 2026
• Study Completion: March 3, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); HU (3); US (15); PR (1); ES (7); NZ (2); BE (5); LA (3); AU (1); SL (4); TU (3)