Graves DiseasePhase 2NCT05907668
A Proof-of-Concept Study to Assess Batoclimab in Participants With Graves' Disease
A Phase 2 study testing IMVT-1401 (batoclimab) in people with Graves Disease, run by Immunovant Sciences GmbH at 1 site in Germany.
Trial summary
The purpose of this study is to assess the efficacy and safety of 24 weeks of treatment with batoclimab in adult participants with biochemically documented hyperthyroidism due to GD who have failed to achieve euthyroidism on antithyroid drugs (ATDs). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graves Disease
- What is being tested?
- IMVT-1401 (batoclimab)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteGermany
- Study dates
- 15 May 2023to 25 Jul 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Have serologically confirmed GD as documented by presence of elevated stimulatory thyrotropin receptor antibody (TSH-R-Ab) level (i.e., > specimen-to-reference ratio of 140%) at the Screening Visit.
- Have active hyperthyroidism due to GD with the following laboratory values at the Screening Visit:
- TSH < LLN
- FT3 > upper limit of normal (ULN) and <=5 * ULN
- FT4 > ULN and <=5 * ULN
- Note: Participants who have T3 thyrotoxicosis (i.e TSH <LLN, FT3 > ULN and ≤5× ULN, but FT4 within normal range) at the Screening Visit may be enrolled, if they have serologically confirmed GD as per Inclusion Criterion 1.
- Are willing and capable of giving written informed consent, which includes being able to comply with all aspects of the study treatment and testing schedule.
Who cannot join
- History of hyperthyroidism not caused by GD (e.g., toxic adenoma or toxic multinodular goiter), and/or history or presence of thyroid storm.
- History of treatment with radioactive iodine or thyroid surgery.
- Total immunoglobulin G (IgG) level <6 grams per liter (g/L) at the Screening Visit.
- Albumin level <3.5 grams per deciliter (g/dL) (<35 g/L) at the Screening Visit.
- Absolute neutrophil count <1000 cells per cubic millimeter (cells/mm^3) at the Screening Visit.
- Other, more specific exclusion criteria are defined in the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: IMVT-1401-2501: A Proof-of-Concept, Open-label Study to Assess the Safety and Efficacy of Batoclimab in Participants With Graves' Disease (GD)
The purpose of this study is to assess the efficacy and safety of 24 weeks of treatment with batoclimab in adult participants with biochemically documented hyperthyroidism due to GD who have failed to achieve euthyroidism on antithyroid drugs (ATDs).
- Conditions
- Graves Disease
- Being tested
- IMVT-1401 (batoclimab)
- Keywords
- Graves' Disease, IMVT-1401, Batoclimab, Hyperthyroidism
- Medical subject headings
- Graves Disease, Hyperthyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMVT-1401 (batoclimab)Drug
Also called IMVT-1401
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody.
| Study group | Role | What they receive |
|---|---|---|
| Batoclimab | Experimental | Participants will receive batoclimab 680 milligrams (mg) subcutaneously (SC) weekly (QW) injection for 12 weeks followed by 340 mg SC QW for 12 weeks. Receives: Drug: IMVT-1401 (batoclimab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Achieved Normalization of Free Triiodothyronine (FT3) and Free Thyroxine (FT4), or Have FT3 and/or FT4 Below the Lower Limit of Normal (LLN) at Week 24 Without Increase in ATD Dose Compared to Baseline
Antithyroid drug therapy was indicated as a first-line treatment for GD by effectively controlling hyperthyroidism. FT3 and FT4 were prespecified biomarkers of GD. Fasting blood samples were collected to assess the percentage of participants who achieved normalization of FT3 and FT4 or levels below the LLN without increase in ATD dose compared to baseline. The change in the ATD dose was compared only between baseline and Week 24 to determine if there was an increase. Percentages were estimated using the 2-sided Clopper-Pearson Exact method, with corresponding 95% confidence intervals. Participants who, at Week 24, without an increase in ATD dose compared with baseline, had achieved normalization of FT3 and FT4, or had FT3 and/or FT4 below the lower limit of normal (LLN), were considered responders. Participants with missing Week 24 assessments were considered nonresponders.
Measured: At Week 24
Secondary outcomes (2)
Percentage of Participants Who Achieved Normalization of FT3 and FT4 With ATD Dose ≤50% of the Baseline ATD Dose at Week 24
Antithyroid drug therapy was indicated as a first-line treatment for GD by effectively controlling hyperthyroidism. FT3 and FT4 were prespecified biomarkers of GD. Fasting blood samples were collected to assess the percentage of participants who achieved normalization of FT3 and FT4 with ATD dose ≤50% of the baseline ATD. The change in the ATD dose was compared only between baseline and Week 24 to determine if there was at least a 50% reduction. Percentages were estimated using the two-sided Clopper-Pearson exact method, with corresponding 95% confidence intervals.
Measured: At Week 24
Percentage of Participants Who Are Off ATD Treatment and Achieved Normalization of FT3 and FT4, or Had FT3 and/or FT4 Below the LLN at Week 24
Antithyroid drug therapy was indicated as a first-line treatment for GD by effectively controlling hyperthyroidism. FT3 and FT4 were prespecified biomarkers of GD. Fasting blood samples were collected to assess the percentage of participants who achieved normalization of FT3 and FT4 or levels below the LLN. Responders were defined as participants who were off ATD therapy at Week 24. Percentages were estimated using the two-sided Clopper-Pearson exact method, with corresponding 95% confidence intervals.
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 posted18 Jun 2023
- Study start15 May 2023
- Primary completion25 Jul 2025
- Study completion25 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Graves 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 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
- NCT05907668
- Sponsor's protocol ID
- IMVT-1401-2501
- Status last verified
- Jul 2026
- First submitted
- 15 May 2023
- Last updated
- 13 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMVT-1401-2501: A Proof-of-Concept, Open-label Study to Assess the Safety and Efficacy of Batoclimab in Participants With Graves' Disease (GD)
- ClinicalTrials.gov ID
- NCT05907668
- Acronym / sponsor ID
- IMVT-1401-2501
- Conditions
- Graves Disease
- Keywords
- Graves' Disease, IMVT-1401, Batoclimab, Hyperthyroidism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Immunovant Sciences GmbHIndustry (pharma, biotech, devices)
- Study start
- 15 May 2023 (actual)
- Primary completion
- 25 Jul 2025 (actual)
- Study completion
- 25 Jul 2025 (actual)
- First posted
- 18 Jun 2023 (actual)
- Results
- Posted 13 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the efficacy and safety of 24 weeks of treatment with batoclimab in adult participants with biochemically documented hyperthyroidism due to GD who have failed to achieve euthyroidism on antithyroid drugs (ATDs).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Batoclimab | Experimental | Drug: IMVT-1401 (batoclimab)Participants will receive batoclimab 680 milligrams (mg) subcutaneously (SC) weekly (QW) injection for 12 weeks followed by 340 mg SC QW 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 (7 listed)
- Have serologically confirmed GD as documented by presence of elevated stimulatory thyrotropin receptor antibody (TSH-R-Ab) level (i.e., > specimen-to-reference ratio of 140%) at the Screening Visit.
- Have active hyperthyroidism due to GD with the following laboratory values at the Screening Visit:
- Note: Participants who have T3 thyrotoxicosis (i.e TSH <LLN, FT3 > ULN and ≤5× ULN, but FT4 within normal range) at the Screening Visit may be enrolled, if they have serologically confirmed GD as per Inclusion Criterion 1.
- Are willing and capable of giving written informed consent, which includes being able to comply with all aspects of the study treatment and testing schedule.
Key exclusion criteria (6 listed)
- History of hyperthyroidism not caused by GD (e.g., toxic adenoma or toxic multinodular goiter), and/or history or presence of thyroid storm.
- History of treatment with radioactive iodine or thyroid surgery.
- Total immunoglobulin G (IgG) level <6 grams per liter (g/L) at the Screening Visit.
- Albumin level <3.5 grams per deciliter (g/dL) (<35 g/L) at the Screening Visit.
- Absolute neutrophil count <1000 cells per cubic millimeter (cells/mm^3) at the Screening Visit.
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 |
|---|---|---|
| IMVT-1401 (batoclimab)Also: IMVT-1401Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody. | Drug | Batoclimab |
Primary outcome
Percentage of Participants Who Achieved Normalization of Free Triiodothyronine (FT3) and Free Thyroxine (FT4), or Have FT3 and/or FT4 Below the Lower Limit of Normal (LLN) at Week 24 Without Increase in ATD Dose Compared to Baseline
Time frame: At Week 24
Antithyroid drug therapy was indicated as a first-line treatment for GD by effectively controlling hyperthyroidism. FT3 and FT4 were prespecified biomarkers of GD. Fasting blood samples were collected to assess the percentage of participants who achieved normalization of FT3 and FT4 or levels below the LLN without increase in ATD dose compared to baseline. The change in the ATD dose was compared only between baseline and Week 24 to determine if there was an increase. Percentages were estimated using the 2-sided Clopper-Pearson Exact method, with corresponding 95% confidence intervals. Participants who, at Week 24, without an increase in ATD dose compared with baseline, had achieved normalization of FT3 and FT4, or had FT3 and/or FT4 below the lower limit of normal (LLN), were considered responders. Participants with missing Week 24 assessments were considered nonresponders.
2 secondary outcomes
Percentage of Participants Who Achieved Normalization of FT3 and FT4 With ATD Dose ≤50% of the Baseline ATD Dose at Week 24
Time frame: At Week 24
Percentage of Participants Who Are Off ATD Treatment and Achieved Normalization of FT3 and FT4, or Had FT3 and/or FT4 Below the LLN at Week 24
Time frame: At Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Graves Disease
Not yet recruiting
Impact of Restrictive Diets on Inflammation and Quality of Life in Autoimmune Thyroiditis
Thyroid Autoimmune Disease, Hashimoto's Thyroiditis
RecruitingPhase 3
A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease
Graves' Disease, Graves Disease
RecruitingPhase 3
A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease.
Graves Disease
Active, not recruitingPhase 4
Hydroxychloroquine in Mild Graves' Orbitopathy
Graves Ophthalmopathy
RecruitingPhase 2
A Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Participants With Graves' Disease
Graves' Disease
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IMVT-1401 (batoclimab) in people with Graves Disease, run by Immunovant Sciences GmbH at 1 site in Germany.
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 7 inclusion and 6 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 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Participants Who Achieved Normalization of Free Triiodothyronine (FT3) and Free Thyroxine (FT4), or Have FT3 and/or FT4 Below the Lower Limit of Normal (LLN) at Week 24 Without Increase in ATD Dose Compared to Baseline (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 13 Aug 2026.