Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease

A Phase 3, Multi-center, Randomized, Quadruple-masked, Placebo-controlled Study of Batoclimab for the Treatment of Participants With Active Thyroid Eye Disease (TED)

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.

Study Overview

• Status: Completed
• Conditions: Thyroid Eye Disease
• Intervention / Treatment: Drug: Batoclimab; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Sydney, Australia, 2000
    • Site Number - 7565
• Belgium
  • Bruges, Belgium, 8000
    • Site Number -4671
  • Brussels, Belgium, 1070
    • Site Number - 4672
  • Brussels, Belgium, 1200
    • Site Number - 4673
  • Ghent, Belgium, B-9000
    • Site Number -4670
  • Liège, Belgium, 4000
    • Site Number - 4674
• Germany
  • Rhineland-Palatinate
    • Mainz, Rhineland-Palatinate, Germany, 55131
      • Site Number - 6603
• Hungary
  • Budapest, Hungary, 1133
    • Site Number - 7550
  • Pécs, Hungary, 7621
    • Site Number - 7551
  • Pécs, Hungary, 7623
    • Site Number - 7552
• Latvia
  • Ogre, Latvia, LV-5001
    • Site Number -9301
  • Riga, Latvia, LV-1006
    • Site Number -9300
  • Ventspils, Latvia, LV-3601
    • Site Number - 9302
• New Zealand
  • Christchurch, New Zealand, 8013
    • Site Number - 7570
  • Hamilton, New Zealand, 3204
    • Site Number - 7572
• Puerto Rico
  • San Juan, Puerto Rico, 00921
    • Site Number -1990
• Slovakia
  • Bratislava, Slovakia, 81108
    • Site Number - 9203
  • Bratislava, Slovakia, 82606
    • Site Number - 9200
  • Bratislava, Slovakia, 85107
    • Site Number - 9201
  • Trenčín, Slovakia, 91101
    • Site Number - 9202
• Spain
  • Barcelona, Spain, 08006
    • Site Number -3602
  • Barcelona, Spain, 08035
    • Site Number - 3605
  • Madrid, Spain, 28007
    • Site Number -3601
  • Madrid, Spain, 28034
    • Site Number -3604
  • Santiago de Compostela, Spain, 15706
    • Site Number -3600
  • Seville, Spain, 41009
    • Site Number -3606
  • Valencia, Spain, 46026
    • Site Number -3603
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 13860
    • Site Number - 4952
  • Ankara, Turkey (Türkiye), 6100
    • Site Number - 4950
  • Istanbul, Turkey (Türkiye), 34010
    • Site Number - 4951
• United States
  • California
    • Pasadena, California, United States, 91107
      • Site Number -1520
    • San Francisco, California, United States, 94143
      • Site Number -1517
    • Torrance, California, United States, 90502
      • Site Number -1514
  • Florida
    • Sarasota, Florida, United States, 34239
      • Site Number -1510
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Site Number -1516
  • Michigan
    • Livonia, Michigan, United States, 48152
      • Site Number - 1526
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Site Number - 1513
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Site Number - 1512
  • Oregon
    • Portland, Oregon, United States, 97239
      • Site Number - 1525
  • Texas
    • Bellaire, Texas, United States, 77401
      • Site Number -1515
    • McAllen, Texas, United States, 78503
      • Site Number - 1524
    • San Antonio, Texas, United States, 78215
      • Site Number -1519
  • Washington
    • Seattle, Washington, United States, 98104
      • Site Number - 1521
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • Site Number -1511
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Site Number - 1518

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

1. Are ≥18 years of age at screening.

2. 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
3. Have moderate to severe active TED, as defined by European Group on Graves' Orbitopathy (EUGOGO) guidelines.
4. Have onset of active TED within 12 months prior to screening.
5. Have documented evidence of detectable anti-TSHR-Ab at screening.
6. 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.
7. Are euthyroid with the Baseline disease under control or have mild hypo- or hyperthyroidism.

Additional inclusion criteria are defined in the protocol.

Exclusion criteria:

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

Additional exclusion criteria are defined in the protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Batoclimab; Participants will be administered batoclimab 680 mg SC weekly for 12 weeks followed by 340 mg SC weekly for 12 weeks.	Drug: Batoclimab; Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody; Other Names: IMVT-1401
Placebo Comparator: Placebo; Participants will be administered matching placebo SC weekly for 24 weeks.	Drug: Placebo; Matching Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	The CAS measures the classical signs of acute inflammation (pain, redness, and swelling) in TED. The 7-item scale assigns 1 point for the presence of each of the parameters assessed: spontaneous retrobulbar pain, pain on attempted upward or downward gaze, redness of eyelids, redness of conjunctiva, swelling of caruncle or plica, swelling of eyelids, swelling of conjunctiva (chemosis). The sum of these points is the total score, with 0 indicating no clinical activity and 7 indicating the most severe clinical activity. Higher scores indicate worse symptoms.	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	Diplopia will be assessed based on 3 grades: Grade I - Intermittent diplopia (diplopia in primary position of gaze, when tired or when first awakening), Grade II - Inconstant diplopia (diplopia at extremes of gaze) and Grade III - Constant diplopia (continuous diplopia in primary or reading position). Higher scores indicate worse symptoms.	Baseline and Week 24
Mean change from Baseline in proptosis in the study eye		Baseline and Week 24
Percentage of participants with ≥6-point increase from Baseline in total Graves' ophthalmopathy - Quality of life (GO-QOL) score	The GO-QOL is a 16-item self-administered questionnaire designed to assess how GO affects different aspects related to quality of life (visual functioning and psychosocial consequences). The points given to questions 1 to 8 and 9 to 16 are added to obtain 2 raw scores ranging from 8 to 24; one for visual functioning and one for appearance. Higher scores indicate better outcome.	Baseline and Week 24
Percentage of participants with ≥8-degree increase from Baseline in motility (in at least 1 of 4 directions) in the study eye		Baseline and Week 24

Collaborators and Investigators

• Sponsor: Immunovant Sciences GmbH

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2023
• Primary Completion (Actual): February 3, 2026
• Study Completion (Actual): March 3, 2026

Study Registration Dates

• First Submitted: August 24, 2022
• First Submitted That Met QC Criteria: August 29, 2022
• First Posted (Actual): September 1, 2022

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Monoclonal antibody; Batoclimab; Thyroid eye disease; IMVT-1401; Autoimmune disorders; Graves' Ophthalmopathy; Graves' Orbitopathy
• Additional Relevant MeSH Terms: Endocrine System Diseases; Genetic Diseases, Inborn; Immune System Diseases; Eye Diseases; Eye Diseases, Hereditary; Graves Disease; Exophthalmos; Orbital Diseases; Goiter; Hyperthyroidism; Thyroid Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Graves Ophthalmopathy; Autoimmune Diseases; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: IMVT-1401-3202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No