Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease

NCT05517421 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: IMVT-1401-3201
• Study Type: interventional
• Target: 114
• Locations: 9 countries
• Sites: 93

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

Batoclimab DRUG

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

Also known as: IMVT-1401

Batoclimab

Placebo DRUG

Matching Placebo

Placebo

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 (93)

Site Number - 1557

Beverly Hills, California, 90210, United States

Location

Site Number - 1539

Carlsbad, California, 92011, United States

Location

Site Number - 1502

Los Angeles, California, 90025, United States

Location

Site Number - 1505

Los Angeles, California, 90033, United States

Location

Site Number - 1532

Los Angeles, California, 90255, United States

Location

Site Number - 1537

San Diego, California, 92108, United States

Location

Site Number - 1531

Torrance, California, 90505, United States

Location

Site Number - 1501

Aurora, Colorado, 80045, United States

Location

Site Number - 1544

Longmont, Colorado, 80503, United States

Location

Site Number - 1547

Newark, Delaware, 19713, United States

Location

Site Number - 1504

Miami, Florida, 33136, United States

Location

Site Number - 1538

Port Charlotte, Florida, 33952, United States

Location

Site Number - 1542

Tampa, Florida, 33603, United States

Location

Site Number - 1536

West Palm Beach, Florida, 33401, United States

Location

Site Number - 1554

Stockbridge, Georgia, 30281, United States

Location

Site Number - 1534

Chicago, Illinois, 60610, United States

Location

Site Number - 1545

Iowa City, Iowa, 52242, United States

Location

Site Number - 1535

Baltimore, Maryland, 21231, United States

Location

Site Number - 1506

Boston, Massachusetts, 02130, United States

Location

Site Number - 1540

Las Vegas, Nevada, 89184, United States

Location

Site Number - 1530

Chapel Hill, North Carolina, 27517, United States

Location

Site Number - 1550

Columbus, Ohio, 43215, United States

Location

Site Number - 1507

Portland, Oregon, 97232, United States

Location

Site Number - 1556

Warwick, Rhode Island, 02886, United States

Location

Site Number - 1551

Dallas, Texas, 75231, United States

Location

Site Number - 1508

Houston, Texas, 77030, United States

Location

Site Number - 1558

Mesquite, Texas, 75149, United States

Location

Site Number - 1500

Roanoke, Virginia, 24018, United States

Location

Site Number - 1509

Madison, Wisconsin, 53705, United States

Location

Site Number - 2502

Edmonton, Alberta, T6G 2E1, Canada

Location

Site Number - 2500

Ottawa, Ontario, K1H 8L6, Canada

Location

Site Number - 2501

Montreal, Quebec, H1T 2M4, Canada

Location

Site Number - 3452

Tbilisi, 0101, Georgia

Location

Site Number - 3454

Tbilisi, 0114, Georgia

Location

Site Number - 3455

Tbilisi, 0114, Georgia

Location

Site Number - 3450

Tbilisi, 0159, Georgia

Location

Site Number - 3451

Tbilisi, 0159, Georgia

Location

Site Number - 3453

Tbilisi, 0186, Georgia

Location

Site Number - 6609

Tübingen, Baden - Wuttemberg, 72076, Germany

Location

Site Number - 6608

Frankfurt am Main, Hesse, 60318, Germany

Location

Site Number - 6604

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Site Number - 6610

Leipzig, Saxony, 04103, Germany

Location

Site Number - 6611

Schwerin, 19049, Germany

Location

Site Number - 4764

Afula, 1834111, Israel

Location

Site Number - 4761

Jerusalem, 91120, Israel

Location

Site Number - 4763

Nahariya, 2210000, Israel

Location

Site Number - 4762

Petah Tikva, 4941492, Israel

Location

Site Number - 4760

Ramat Gan, 5265601, Israel

Location

Site Number - 6206

Bologna, 40138, Italy

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 - 6200

Pisa, 56100, Italy

Location

Site Number - 6201

Pisa, 56124, Italy

Location

Site Number - 6202

Roma, 00189, Italy

Location

Site Number - 6208

Rome, 00161, Italy

Location

Site Number - 7415

Maebashi, Gunma, 371-8511, Japan

Location

Site Number- 7418

Hokkaido, Sapporo, 060-8648, Japan

Location

Site Number - 7401

Fukuoka, 812-0011, Japan

Location

Site Number - 7403

Hyōgo, 663-8501, Japan

Location

Site Number - 7411

Ibaraki, 305-8576, Japan

Location

Site Number - 7410

Kanagawa, 230-8765, Japan

Location

Site Number - 7402

Kitakyushu, 807-8556, Japan

Location

Site Number - 7417

Kobe, 657-0068, Japan

Location

Site Number - 7416

Kumamoto, 860-8556, Japan

Location

Site Number - 7414

Miyazaki, 889-1692, Japan

Location

Site Number - 7407

Nagasaki, 852-8501, Japan

Location

Site Number - 7406

Nagoya, 467-8602, Japan

Location

Site Number - 7412

Nankoku, 783-0043, Japan

Location

Site Number - 7408

Osaka, 545-0051, Japan

Location

Site Number - 7409

Tokyo, 173-8610, Japan

Location

Site Number - 7404

Tottori, 683-8504, Japan

Location

Site Number - 7413

Yamaguchi, 754-0002, Japan

Location

Site Number - 3107

Gliwice, 44-102, Poland

Location

Site Number - 3103

Katowice, 40-514, Poland

Location

Site Number - 3101

Krakow, 30-688, Poland

Location

Site Number - 3104

Lublin, 20-171, Poland

Location

Site Number - 3102

Lublin, 20-562, Poland

Location

Site Number - 3105

Lublin, 60-354, Poland

Location

Site Number - 3106

Olsztyn, 10-561, Poland

Location

Site Number - 3100

Warsaw, 02-097, Poland

Location

Site Number - 7305

Guildford, GU2 7XX, United Kingdom

Location

Site Number - 7310

Hull, HU6 7RX, United Kingdom

Location

Site Number - 7309

Leicester, LE15WW, United Kingdom

Location

Site Number - 7303

London, EC1V 2PD, United Kingdom

Location

Site Number - 7311

London, SE17EH, 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: 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: August 26, 2022
• Study Start: November 23, 2022
• Primary Completion: November 2, 2025
• Study Completion: November 18, 2025
• Last Updated: December 3, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (10); JP (17); PL (8); GB (10); GE (6); US (29); CA (3); IL (5); DE (5)