Thyroid Eye DiseasePhase 3NCT05517447
Extension Study to Assess Batoclimab in Participants With Thyroid Eye Disease
A Phase 3 study testing Observational cohort study and Batoclimab in people with Thyroid Eye Disease, run by Immunovant Sciences GmbH at 55 sites in 14 countries.
Trial summary
This is a 2-cohort (observational and treatment cohort) extension study for participants completing feeder studies (IMVT-1401-3201 or IMVT-1401-3202). The observational cohort will assess the durability of proptosis response of feeder studies off treatment. 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?
- Observational cohort study and Batoclimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 55 sitesin 14 countries
- Study dates
- 6 Nov 2022to 2 Apr 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
- For all participants:
- 1. Have completed the Week 24 visit of the feeder study.
- For participants assigned to the Open-label Treatment Cohort:
- Do not require immediate surgical intervention and is not planning corrective surgery/irradiation or medical therapy for TED during the course of the study.
- Did not permanently discontinue batoclimab
- Additional inclusion criteria are defined in the protocol.
Who cannot join
- For all participants:
- 1. In the Investigator's judgement, the benefits of entry in the study do not outweigh the risk.
Trial locations and contacts
55 sites in 14 countries.
55 sites in 14 countries
United States9 sites
Site Number - 1501
Aurora, Colorado, 80045
Site Number - 1520
Glendora, California, 91741
Site Number - 1508
Houston, Texas, 77030
Site Number - 1540
Las Vegas, Nevada, 89184
Site Number - 1526
Livonia, Michigan, 48152
Site Number - 1558
Mesquite, Texas, 75149
Site Number - 1518
Milwaukee, Wisconsin, 53226
Site Number - 1511
Morgantown, West Virginia, 26506
Site Number - 1513
Rochester, Minnesota, 55905
Italy7 sites
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 - 6201
Pisa, 56124
Site Number - 6202
Rome, 00189
United Kingdom7 sites
Site Number - 7305
Guildford, GU2 7XX
Site Number - 7303
London, EC1V 2PD
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
Spain5 sites
Site Number - 3602
Barcelona, Catalonia, 8006
Site Number - 3604
Madrid, 28034
Site Number - 3600
Santiago de Compostela, 15706
Site Number - 3606
Seville, 41009
Site Number - 3603
Valencia, 46026
Belgium4 sites
Site Number - 4671
Bruges, 8000
Site Number - 4672
Brussels, 1070
Site Number - 4673
Brussels, 1200
Site Number - 4670
Ghent, B-9000
Georgia4 sites
Site Number - 3454
Tbilisi, 114
Site Number - 3455
Tbilisi, 114
Site Number - 3450
Tbilisi, 159
Site Number - 3451
Tbilisi, 159
Israel4 sites
Site Number - 4764
Afula, 1834111
Site Number - 4761
Jerusalem, 91120
Site Number - 4762
Petah Tikva, 4941492
Site Number - 4760
Ramat Gan, Tel Aviv, 5265601
Poland4 sites
Site Number - 3107
Gliwice, Silesian Voivodeship, 44-102
Site Number - 3101
Krakow, 30-688
Site Number - 3104
Lublin, 20-171
Site Number - 3105
Lublin, 60-354
Latvia3 sites
Site Number - 9301
Ogre, LV-5001
Site Number - 9300
Riga, LV-1006
Site Number - 9302
Ventspils, LV3601
Slovakia3 sites
Site Number - 9200
Bratislava, 82606
Site Number - 9201
Bratislava
Site Number - 9202
Trenčín, 91101
About this study
Official title: An Open-label Extension Study for Participants Who Completed Study IMVT-1401-3201 or Study IMVT-1401-3202 to Assess the Efficacy and Safety of Batoclimab for the Treatment of Thyroid Eye Disease (TED)
This is a 2-cohort (observational and treatment cohort) extension study for participants completing feeder studies (IMVT-1401-3201 or IMVT-1401-3202). The observational cohort will assess the durability of proptosis response of feeder studies off treatment. The treatment cohort will evaluate the efficacy of batoclimab as assessed by proptosis responder rate.
- Conditions
- Thyroid Eye Disease
- Being tested
- Observational cohort study, Batoclimab
- 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.
Observational cohort studyOther
Observational cohort study
BatoclimabDrug
Also called IMVT-1401
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| Observational cohort | Other | Proptosis responders in feeder studies will enter in a non-treatment observational study Receives: Other: Observational cohort study |
| Treatment Cohort | Experimental | Proptosis non-responders in feeder studies will be administered batoclimab of 680 milligram (mg) subcutaneous (SC) for 12 weeks followed by 340 mg SC for 12 weeks Receives: Drug: Batoclimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of proptosis response off treatment in study eye in batoclimab responder participants in the feeder studies
Measured: Up to Week 24
Secondary outcomes (2)
Percentage of proptosis responders in study eye in placebo non-responder participants in the feeder studies
Measured: At Week 24
Percentage of proptosis responders in study eye in batoclimab non-responder participants in the feeder studies
Measured: At Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start6 Nov 2022
- Primary completion2 Apr 2026
- Study completion2 Apr 2026
Why it stopped: The feeder studies (i.e., IMVT-1401-3201 and 3202) for study IMVT-1401-3203 failed to achieve their pre-defined primary efficacy outcomes. Accordingly, there was a change to the benefit-risk balance. No new safety findings were observed.
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 109 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
- NCT05517447
- Sponsor's protocol ID
- IMVT-1401-3203
- Status last verified
- Apr 2026
- First submitted
- 24 Aug 2022
- Last updated
- 29 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 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Extension Study for Participants Who Completed Study IMVT-1401-3201 or Study IMVT-1401-3202 to Assess the Efficacy and Safety of Batoclimab for the Treatment of Thyroid Eye Disease (TED)
- ClinicalTrials.gov ID
- NCT05517447
- Acronym / sponsor ID
- IMVT-1401-3203
- 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
- TerminatedReason stopped: The feeder studies (i.e., IMVT-1401-3201 and 3202) for study IMVT-1401-3203 failed to achieve their pre-defined primary efficacy outcomes. Accordingly, there was a change to the benefit-risk balance. No new safety findings were observed.
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Immunovant Sciences GmbHIndustry (pharma, biotech, devices)
- Study start
- 6 Nov 2022 (actual)
- Primary completion
- 2 Apr 2026 (actual)
- Study completion
- 2 Apr 2026 (actual)
- First posted
- 26 Aug 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.
This is a 2-cohort (observational and treatment cohort) extension study for participants completing feeder studies (IMVT-1401-3201 or IMVT-1401-3202). The observational cohort will assess the durability of proptosis response of feeder studies off treatment. The treatment cohort will evaluate the efficacy of batoclimab as assessed by proptosis responder rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observational cohort | Other | Other: Observational cohort studyProptosis responders in feeder studies will enter in a non-treatment observational study |
| Treatment Cohort | Experimental | Drug: BatoclimabProptosis non-responders in feeder studies will be administered batoclimab of 680 milligram (mg) subcutaneous (SC) for 12 weeks followed by 340 mg SC for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1. Have completed the Week 24 visit of the feeder study.
- Do not require immediate surgical intervention and is not planning corrective surgery/irradiation or medical therapy for TED during the course of the study.
- Did not permanently discontinue batoclimab
- Additional inclusion criteria are defined in the protocol.
Key exclusion criteria (2 listed)
- 1. In the Investigator's judgement, the benefits of entry in the study do not outweigh the risk.
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 |
|---|---|---|
| Observational cohort studyObservational cohort study | Other | Observational cohort |
| BatoclimabAlso: IMVT-1401Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody | Drug | Treatment Cohort |
Primary outcome
Duration of proptosis response off treatment in study eye in batoclimab responder participants in the feeder studies
Time frame: Up to Week 24
2 secondary outcomes
Percentage of proptosis responders in study eye in placebo non-responder participants in the feeder studies
Time frame: At Week 24
Percentage of proptosis responders in study eye in batoclimab non-responder participants in the feeder studies
Time frame: At Week 24
Results and safety
The study was stopped early (reason given: The feeder studies (i.e., IMVT-1401-3201 and 3202) for study IMVT-1401-3203 failed to achieve their pre-defined primary efficacy outcomes. Accordingly, there was a change to the benefit-risk balance. No new safety findings were observed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 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.
55 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Observational cohort study and Batoclimab in people with Thyroid Eye Disease, run by Immunovant Sciences GmbH at 55 sites in 14 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 6 inclusion and 2 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: stopped early, as of the sponsor's last update on 29 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 55 sites in United States, Italy, United Kingdom, Spain, Belgium and 9 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. 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 was stopped early (reason given: The feeder studies (i.e., IMVT-1401-3201 and 3202) for study IMVT-1401-3203 failed to achieve their pre-defined primary efficacy outcomes. Accordingly, there was a change to the benefit-risk balance. No new safety findings were observed.). Results are not available in the source record.
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?
Duration of proptosis response off treatment in study eye in batoclimab responder participants in the feeder studies (time frame: Up to 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 29 Apr 2026.