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Thyroid Eye DiseasePhase 3NCT05517421

Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease

A Phase 3 study testing Batoclimab in people with Thyroid Eye Disease, run by Immunovant Sciences GmbH at 93 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Thyroid Eye Disease
What is being tested?
Batoclimab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
114 participants
Where
93 sitesin 9 countries
Study dates
23 Nov 2022to 18 Nov 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

93 sites in 9 countries.

93 sites in 9 countries

United States29 sites

  • Site Number - 1501

    Aurora, Colorado, 80045

  • Site Number - 1535

    Baltimore, Maryland, 21231

  • Site Number - 1557

    Beverly Hills, California, 90210

  • Site Number - 1506

    Boston, Massachusetts, 02130

  • Site Number - 1539

    Carlsbad, California, 92011

  • Site Number - 1530

    Chapel Hill, North Carolina, 27517

  • Site Number - 1534

    Chicago, Illinois, 60610

  • Site Number - 1550

    Columbus, Ohio, 43215

  • Site Number - 1551

    Dallas, Texas, 75231

  • Site Number - 1508

    Houston, Texas, 77030

  • Site Number - 1545

    Iowa City, Iowa, 52242

  • Site Number - 1540

    Las Vegas, Nevada, 89184

  • Site Number - 1544

    Longmont, Colorado, 80503

  • Site Number - 1502

    Los Angeles, California, 90025

  • Site Number - 1505

    Los Angeles, California, 90033

  • Site Number - 1532

    Los Angeles, California, 90255

  • Site Number - 1509

    Madison, Wisconsin, 53705

  • Site Number - 1558

    Mesquite, Texas, 75149

  • Site Number - 1504

    Miami, Florida, 33136

  • Site Number - 1547

    Newark, Delaware, 19713

  • Site Number - 1538

    Port Charlotte, Florida, 33952

  • Site Number - 1507

    Portland, Oregon, 97232

  • Site Number - 1500

    Roanoke, Virginia, 24018

  • Site Number - 1537

    San Diego, California, 92108

  • Site Number - 1554

    Stockbridge, Georgia, 30281

  • Site Number - 1542

    Tampa, Florida, 33603

  • Site Number - 1531

    Torrance, California, 90505

  • Site Number - 1556

    Warwick, Rhode Island, 02886

  • Site Number - 1536

    West Palm Beach, Florida, 33401

Other trials in United States

Japan17 sites

  • Site Number - 7401

    Fukuoka, 812-0011

  • Site Number- 7418

    Hokkaido, Sapporo, 060-8648

  • Site Number - 7403

    Hyōgo, 663-8501

  • Site Number - 7411

    Ibaraki, 305-8576

  • Site Number - 7410

    Kanagawa, 230-8765

  • Site Number - 7402

    Kitakyushu, 807-8556

  • Site Number - 7417

    Kobe, 657-0068

  • Site Number - 7416

    Kumamoto, 860-8556

  • Site Number - 7415

    Maebashi, Gunma, 371-8511

  • Site Number - 7414

    Miyazaki, 889-1692

  • Site Number - 7407

    Nagasaki, 852-8501

  • Site Number - 7406

    Nagoya, 467-8602

  • Site Number - 7412

    Nankoku, 783-0043

  • Site Number - 7408

    Osaka, 545-0051

  • Site Number - 7409

    Tokyo, 173-8610

  • Site Number - 7404

    Tottori, 683-8504

  • Site Number - 7413

    Yamaguchi, 754-0002

Other trials in Japan

Italy10 sites

  • Site Number - 6206

    Bologna, 40138

  • Site Number - 6207

    Catania, CAP95125

  • Site Number - 6204

    Milan, 20122

  • Site Number - 6203

    Milan, 20149

  • Site Number - 6205

    Naples, 80131

  • Site Number - 6209

    Palermo, 90127

  • Site Number - 6200

    Pisa, 56100

  • Site Number - 6201

    Pisa, 56124

  • Site Number - 6202

    Roma, 00189

  • Site Number - 6208

    Rome, 00161

Other trials in Italy

United Kingdom10 sites

  • Site Number - 7305

    Guildford, GU2 7XX

  • Site Number - 7310

    Hull, HU6 7RX

  • Site Number - 7309

    Leicester, LE15WW

  • Site Number - 7303

    London, EC1V 2PD

  • Site Number - 7311

    London, SE17EH

  • Site Number - 7312

    London, W1T 6AH

  • Site Number - 7313

    London, W1T 7HA

  • Site Number - 7300

    Manchester, M139WL

  • Site Number - 7302

    Newcastle upon Tyne, NE1 3BZ

  • Site Number - 7308

    Sheffield, S102SB

Other trials in United Kingdom

Poland8 sites

  • Site Number - 3107

    Gliwice, 44-102

  • Site Number - 3103

    Katowice, 40-514

  • Site Number - 3101

    Krakow, 30-688

  • Site Number - 3104

    Lublin, 20-171

  • Site Number - 3102

    Lublin, 20-562

  • Site Number - 3105

    Lublin, 60-354

  • Site Number - 3106

    Olsztyn, 10-561

  • Site Number - 3100

    Warsaw, 02-097

Other trials in Poland

Georgia6 sites

  • Site Number - 3452

    Tbilisi, 0101

  • Site Number - 3454

    Tbilisi, 0114

  • Site Number - 3455

    Tbilisi, 0114

  • Site Number - 3450

    Tbilisi, 0159

  • Site Number - 3451

    Tbilisi, 0159

  • Site Number - 3453

    Tbilisi, 0186

Other trials in Georgia

Germany5 sites

  • Site Number - 6608

    Frankfurt am Main, Hesse, 60318

  • Site Number - 6610

    Leipzig, Saxony, 04103

  • Site Number - 6604

    Mainz, Rhineland-Palatinate, 55131

  • Site Number - 6611

    Schwerin, 19049

  • Site Number - 6609

    Tübingen, Baden - Wuttemberg, 72076

Other trials in Germany

Israel5 sites

  • Site Number - 4764

    Afula, 1834111

  • Site Number - 4761

    Jerusalem, 91120

  • Site Number - 4763

    Nahariya, 2210000

  • Site Number - 4762

    Petah Tikva, 4941492

  • Site Number - 4760

    Ramat Gan, 5265601

Other trials in Israel

Canada3 sites

  • Site Number - 2502

    Edmonton, Alberta, T6G 2E1

  • Site Number - 2501

    Montreal, Quebec, H1T 2M4

  • Site Number - 2500

    Ottawa, Ontario, K1H 8L6

Other trials in Canada

About this study

Official title: 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.

Being tested
Batoclimab, Placebo
Keywords
Batoclimab, Thyroid eye disease, IMVT-1401, Monoclonal antibody, Autoimmune disorders, Graves' Ophthalmopathy, Graves' Orbitopathy
Medical subject headings
Graves Ophthalmopathy, Autoimmune Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BatoclimabDrug

    Also called IMVT-1401

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

  • PlaceboDrug

    Matching Placebo

Study groups in NCT05517421
Study groupRoleWhat they receive
BatoclimabExperimentalParticipants will be administered batoclimab 680 mg SC weekly for 12 weeks followed by 340 mg SC weekly for 12 weeks.
Receives: Drug: Batoclimab
PlaceboPlacebo comparatorParticipants will be administered matching placebo SC weekly for 24 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At Week 24

Secondary outcomes (8)

  1. 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.

    Measured: Baseline and Week 24

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

    Measured: At Week 24

  3. Mean change from Baseline in CAS in the study eye

    Measured: Baseline and Week 24

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

    Measured: Baseline and Week 24

  5. 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.

    Measured: Baseline and Week 24

  6. Mean change from Baseline in proptosis in the study eye

    Measured: Baseline and Week 24

  7. 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.

    Measured: Baseline and Week 24

  8. Percentage of participants with ≥8-degree increase from Baseline in motility (in at least 1 of 4 directions) in the study eye

    Measured: Baseline and Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2022
  2. Study start23 Nov 2022
  3. Primary completion2 Nov 2025
  4. Study completion18 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
114 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05517421
Sponsor's protocol ID
IMVT-1401-3201
Status last verified
Dec 2025
First submitted
24 Aug 2022
Last updated
3 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Batoclimab in people with Thyroid Eye Disease, run by Immunovant Sciences GmbH at 93 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 93 sites in United States, Japan, Italy, United Kingdom, Poland and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of proptosis responders (time frame: At Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05517421.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.

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