Thyroid Eye DiseasePhase 3NCT05524571
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 45 sites in 11 countries.
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
- 86 participants
- Where
- 45 sitesin 11 countries
- Study dates
- 5 Jan 2023to 3 Mar 2026
- 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
45 sites in 11 countries.
45 sites in 11 countries
United States15 sites
Site Number -1515
Bellaire, Texas, 77401
Site Number - 1526
Livonia, Michigan, 48152
Site Number -1516
Louisville, Kentucky, 40202
Site Number - 1524
McAllen, Texas, 78503
Site Number - 1518
Milwaukee, Wisconsin, 53226
Site Number -1511
Morgantown, West Virginia, 26506
Site Number -1520
Pasadena, California, 91107
Site Number - 1525
Portland, Oregon, 97239
Site Number - 1513
Rochester, Minnesota, 55905
Site Number -1519
San Antonio, Texas, 78215
Site Number -1517
San Francisco, California, 94143
Site Number -1510
Sarasota, Florida, 34239
Site Number - 1521
Seattle, Washington, 98104
Site Number -1514
Torrance, California, 90502
Site Number - 1512
Winston-Salem, North Carolina, 27157
Spain7 sites
Site Number -3602
Barcelona, 08006
Site Number - 3605
Barcelona, 08035
Site Number -3601
Madrid, 28007
Site Number -3604
Madrid, 28034
Site Number -3600
Santiago de Compostela, 15706
Site Number -3606
Seville, 41009
Site Number -3603
Valencia, 46026
Belgium5 sites
Site Number -4671
Bruges, 8000
Site Number - 4672
Brussels, 1070
Site Number - 4673
Brussels, 1200
Site Number -4670
Ghent, B-9000
Site Number - 4674
Liège, 4000
Slovakia4 sites
Site Number - 9203
Bratislava, 81108
Site Number - 9200
Bratislava, 82606
Site Number - 9201
Bratislava, 85107
Site Number - 9202
Trenčín, 91101
Hungary3 sites
Site Number - 7550
Budapest, 1133
Site Number - 7551
Pécs, 7621
Site Number - 7552
Pécs, 7623
Latvia3 sites
Site Number -9301
Ogre, LV-5001
Site Number -9300
Riga, LV-1006
Site Number - 9302
Ventspils, LV-3601
Turkey (Türkiye)3 sites
Site Number - 4952
Adana, 13860
Site Number - 4950
Ankara, 6100
Site Number - 4951
Istanbul, 34010
New Zealand2 sites
Site Number - 7570
Christchurch, 8013
Site Number - 7572
Hamilton, 3204
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.
- Conditions
- Thyroid Eye Disease
- 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 group | Role | What they receive |
|---|---|---|
| Batoclimab | Experimental | Participants will be administered batoclimab 680 mg SC weekly for 12 weeks followed by 340 mg SC weekly for 12 weeks. Receives: Drug: Batoclimab |
| Placebo | Placebo comparator | Participants 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.
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)
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
Percentage of participants with CAS of 0 or 1 in the study eye
Measured: At Week 24
Mean change from Baseline in CAS in the study eye
Measured: Baseline and Week 24
Percentage of participants with positive binding anti-thyroid stimulating hormone receptor (TSHR) antibody (Ab) at Baseline who achieve seroconversion
Measured: 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.
Measured: Baseline and Week 24
Mean change from Baseline in proptosis in the study eye
Measured: 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.
Measured: 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
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.
- First posted1 Sep 2022
- Study start5 Jan 2023
- Primary completion3 Feb 2026
- Study completion3 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Eye DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Immunovant Sciences GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05524571
- Sponsor's protocol ID
- IMVT-1401-3202
- Status last verified
- Mar 2026
- First submitted
- 24 Aug 2022
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05524571
- Acronym / sponsor ID
- IMVT-1401-3202
- Conditions
- Thyroid Eye Disease
- Keywords
- Batoclimab, Thyroid eye disease, IMVT-1401, Monoclonal antibody, Autoimmune disorders, Graves' Ophthalmopathy, Graves' Orbitopathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Immunovant Sciences GmbHIndustry (pharma, biotech, devices)
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- 3 Feb 2026 (actual)
- Study completion
- 3 Mar 2026 (actual)
- First posted
- 1 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Batoclimab | Experimental | Drug: BatoclimabParticipants will be administered batoclimab 680 mg SC weekly for 12 weeks followed by 340 mg SC weekly for 12 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will be administered matching placebo SC weekly for 24 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BatoclimabAlso: IMVT-1401Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody | Drug | Batoclimab |
| PlaceboMatching Placebo | Drug | Placebo |
Primary outcome
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.
8 secondary outcomes
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
Percentage of participants with CAS of 0 or 1 in the study eye
Time frame: At Week 24
Mean change from Baseline in CAS in the study eye
Time frame: 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
Percentage of participants with decrease of at least 1 grade from Baseline in Gorman score for diplopia
Time frame: Baseline and Week 24
Mean change from Baseline in proptosis in the study eye
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
45 sites in 11 countries: see every site and its status.
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 45 sites in 11 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 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States, Spain, Belgium, Slovakia, Hungary and 6 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?
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 1 Apr 2026.