Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease

December 2, 2025 updated by: Immunovant Sciences GmbH

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

114

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2E1
        • Site Number - 2502
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Site Number - 2500
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • Site Number - 2501
  • Georgia
      • Tbilisi, Georgia, 0101
        • Site Number - 3452
      • Tbilisi, Georgia, 0114
        • Site Number - 3454
      • Tbilisi, Georgia, 0114
        • Site Number - 3455
      • Tbilisi, Georgia, 0159
        • Site Number - 3450
      • Tbilisi, Georgia, 0159
        • Site Number - 3451
      • Tbilisi, Georgia, 0186
        • Site Number - 3453
  • Germany
      • Schwerin, Germany, 19049
        • Site Number - 6611
    • Baden - Wuttemberg
      • Tübingen, Baden - Wuttemberg, Germany, 72076
        • Site Number - 6609
    • Hesse
      • Frankfurt am Main, Hesse, Germany, 60318
        • Site Number - 6608
    • Rhineland-Palatinate
      • Mainz, Rhineland-Palatinate, Germany, 55131
        • Site Number - 6604
    • Saxony
      • Leipzig, Saxony, Germany, 04103
        • Site Number - 6610
  • Israel
      • Afula, Israel, 1834111
        • Site Number - 4764
      • Jerusalem, Israel, 91120
        • Site Number - 4761
      • Nahariya, Israel, 2210000
        • Site Number - 4763
      • Petah Tikva, Israel, 4941492
        • Site Number - 4762
      • Ramat Gan, Israel, 5265601
        • Site Number - 4760
  • Italy
      • Bologna, Italy, 40138
        • Site Number - 6206
      • Catania, Italy, CAP95125
        • Site Number - 6207
      • Milan, Italy, 20122
        • Site Number - 6204
      • Milan, Italy, 20149
        • Site Number - 6203
      • Napoli, Italy, 80131
        • Site Number - 6205
      • Palermo, Italy, 90127
        • Site Number - 6209
      • Pisa, Italy, 56100
        • Site Number - 6200
      • Pisa, Italy, 56124
        • Site Number - 6201
      • Roma, Italy, 00189
        • Site Number - 6202
      • Rome, Italy, 00161
        • Site Number - 6208
  • Japan
      • Fukuoka, Japan, 812-0011
        • Site Number - 7401
      • Hyōgo, Japan, 663-8501
        • Site Number - 7403
      • Ibaraki, Japan, 305-8576
        • Site Number - 7411
      • Kanagawa, Japan, 230-8765
        • Site Number - 7410
      • Kitakyushu, Japan, 807-8556
        • Site Number - 7402
      • Kobe, Japan, 657-0068
        • Site Number - 7417
      • Kumamoto, Japan, 860-8556
        • Site Number - 7416
      • Miyazaki, Japan, 889-1692
        • Site Number - 7414
      • Nagasaki, Japan, 852-8501
        • Site Number - 7407
      • Nagoya, Japan, 467-8602
        • Site Number - 7406
      • Nankoku, Japan, 783-0043
        • Site Number - 7412
      • Osaka, Japan, 545-0051
        • Site Number - 7408
      • Tokyo, Japan, 173-8610
        • Site Number - 7409
      • Tottori, Japan, 683-8504
        • Site Number - 7404
      • Yamaguchi, Japan, 754-0002
        • Site Number - 7413
    • Gunma
      • Maebashi, Gunma, Japan, 371-8511
        • Site Number - 7415
    • Sapporo
      • Hokkaido, Sapporo, Japan, 060-8648
        • Site Number- 7418
  • Poland
      • Gliwice, Poland, 44-102
        • Site Number - 3107
      • Katowice, Poland, 40-514
        • Site Number - 3103
      • Krakow, Poland, 30-688
        • Site Number - 3101
      • Lublin, Poland, 20-171
        • Site Number - 3104
      • Lublin, Poland, 20-562
        • Site Number - 3102
      • Lublin, Poland, 60-354
        • Site Number - 3105
      • Olsztyn, Poland, 10-561
        • Site Number - 3106
      • Warsaw, Poland, 02-097
        • Site Number - 3100
  • United Kingdom
      • Guildford, United Kingdom, GU2 7XX
        • Site Number - 7305
      • Hull, United Kingdom, HU6 7RX
        • Site Number - 7310
      • Leicester, United Kingdom, LE15WW
        • Site Number - 7309
      • London, United Kingdom, EC1V 2PD
        • Site Number - 7303
      • London, United Kingdom, SE17EH
        • Site Number - 7311
      • London, United Kingdom, W1T 6AH
        • Site Number - 7312
      • London, United Kingdom, W1T 7HA
        • Site Number - 7313
      • Manchester, United Kingdom, M139WL
        • Site Number - 7300
      • Newcastle upon Tyne, United Kingdom, NE1 3BZ
        • Site Number - 7302
      • Sheffield, United Kingdom, S102SB
        • Site Number - 7308
  • United States
    • California
      • Beverly Hills, California, United States, 90210
        • Site Number - 1557
      • Carlsbad, California, United States, 92011
        • Site Number - 1539
      • Los Angeles, California, United States, 90025
        • Site Number - 1502
      • Los Angeles, California, United States, 90033
        • Site Number - 1505
      • Los Angeles, California, United States, 90255
        • Site Number - 1532
      • San Diego, California, United States, 92108
        • Site Number - 1537
      • Torrance, California, United States, 90505
        • Site Number - 1531
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Site Number - 1501
      • Longmont, Colorado, United States, 80503
        • Site Number - 1544
    • Delaware
      • Newark, Delaware, United States, 19713
        • Site Number - 1547
    • Florida
      • Miami, Florida, United States, 33136
        • Site Number - 1504
      • Port Charlotte, Florida, United States, 33952
        • Site Number - 1538
      • Tampa, Florida, United States, 33603
        • Site Number - 1542
      • West Palm Beach, Florida, United States, 33401
        • Site Number - 1536
    • Georgia
      • Stockbridge, Georgia, United States, 30281
        • Site Number - 1554
    • Illinois
      • Chicago, Illinois, United States, 60610
        • Site Number - 1534
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Site Number - 1545
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • Site Number - 1535
    • Massachusetts
      • Boston, Massachusetts, United States, 02130
        • Site Number - 1506
    • Nevada
      • Las Vegas, Nevada, United States, 89184
        • Site Number - 1540
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27517
        • Site Number - 1530
    • Ohio
      • Columbus, Ohio, United States, 43215
        • Site Number - 1550
    • Oregon
      • Portland, Oregon, United States, 97232
        • Site Number - 1507
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • Site Number - 1556
    • Texas
      • Dallas, Texas, United States, 75231
        • Site Number - 1551
      • Houston, Texas, United States, 77030
        • Site Number - 1508
      • Mesquite, Texas, United States, 75149
        • Site Number - 1558
    • Virginia
      • Roanoke, Virginia, United States, 24018
        • Site Number - 1500
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • Site Number - 1509

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • 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:

      1. Proptosis ≥ 18 mm and/or
      2. 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.

Additional inclusion criteria are defined in the protocol.

Exclusion criteria:

  • 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.

Additional exclusion criteria are defined in the protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: At Week 24
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
Time Frame: Baseline and Week 24
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
Time Frame: At Week 24
At Week 24
Mean change from Baseline in CAS in the study eye
Time Frame: Baseline and Week 24
Baseline and Week 24
Percentage of participants with positive binding anti-thyroid stimulating hormone receptor (TSHR) antibody (Ab) at Baseline who achieve seroconversion
Time Frame: Baseline and Week 24
Baseline and Week 24
Percentage of participants with decrease of at least 1 grade from Baseline in Gorman score for diplopia
Time Frame: Baseline and Week 24
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
Time Frame: Baseline and Week 24
Baseline and Week 24
Percentage of participants with ≥6-point increase from Baseline in total Graves' ophthalmopathy - Quality of life (GO-QOL) score
Time Frame: Baseline and Week 24
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
Time Frame: Baseline and Week 24
Baseline and Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Immunovant Sciences GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 23, 2022

Primary Completion (Actual)

November 2, 2025

Study Completion (Actual)

November 18, 2025

Study Registration Dates

First Submitted

August 24, 2022

First Submitted That Met QC Criteria

August 24, 2022

First Posted (Actual)

August 26, 2022

Study Record Updates

Last Update Posted (Estimated)

December 3, 2025

Last Update Submitted That Met QC Criteria

December 2, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMVT-1401-3201

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe