A Phase 2 interventional study of IMVT-1401 (batoclimab) in Graves Disease, sponsored by Immunovant Sciences GmbH. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by Immunovant Sciences GmbH · Phase 2, Interventional, and Treatment
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).
162 studies on the registry are indexed under Graves Disease; 53 are open to participants now.
This study's enrollment of 32 is below the median of 60 across 104 interventional studies indexed under Graves Disease.
Browse Graves Disease studies →Immunovant Sciences GmbH is the lead sponsor of 19 studies on the registry; 5 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 5 (45%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Exclusion Criteria:
Other, more specific exclusion criteria are defined in the protocol.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive batoclimab 680 milligrams (mg) subcutaneously (SC) weekly (QW) injection for 12 weeks followed by 340 mg SC QW for 12 weeks.
Drug: IMVT-1401 (batoclimab)
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody.
Also known as: IMVT-1401
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.
Time frame: At Week 24
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.
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
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.
Time frame: At Week 24
A total of 32 participants were enrolled in the study in a proof-of-concept, open-label study that evaluated the safety and efficacy of 24 weeks of treatment with batoclimab in adults with biochemically confirmed hyperthyroidism due to Graves' disease (GD) who had failed to achieve euthyroidism on antithyroid drugs (ATDs).
| Milestone | Batoclimab |
|---|---|
| Started | 32 |
| Completed | 25 |
| Not completed | 7 |
| Withdrew: Adverse event | 1 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Not eligible to continue into 24 week follow up period | 4 |
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.
| percentage of participants | Batoclimab |
|---|---|
| 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 | 68.8 (50.0 to 83.9) |
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.
| percentage of participants | Batoclimab |
|---|---|
| Percentage of Participants Who Achieved Normalization of FT3 and FT4 With ATD Dose ≤50% of the Baseline ATD Dose at Week 24 | 53.1 (34.7 to 70.9) |
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.
| percentage of participants | Batoclimab |
|---|---|
| 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 | 31.3 (16.1 to 50.0) |
Collected over Up to Week 48. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Batoclimab | 0/32 (0%) | 3/32 (9.4%) | 32/32 (100%) |
| Event | Batoclimab |
|---|---|
| CholelithiasisHepatobiliary disorders | 1/32 |
| Amaurosis fugaxEye disorders | 1/32 |
| Endocrine ophthalmopathyEye disorders | 1/32 |
| Event | Batoclimab |
|---|---|
| Injection site erythemaGeneral disorders | 29/32 |
| Injection site swellingGeneral disorders | 22/32 |
| Oedema peripheralGeneral disorders | 20/32 |
| NasopharyngitisInfections and infestations | 20/32 |
| Injection site haematomaGeneral disorders | 17/32 |
| Muscle spasmsMusculoskeletal and connective tissue disorders | 13/32 |
| FatigueGeneral disorders | 11/32 |
| HeadacheNervous system disorders | 10/32 |
| COVID-19Infections and infestations | 9/32 |
| Weight increasedInvestigations | 8/32 |
Safety Analysis Population comprised of all participants who received at least one dose of study treatment.
| Age, Continuous(years) | Batoclimab |
|---|---|
| Mean | 46.9 ± 12.43 |
| Sex: Female, Male(Participants) | Batoclimab |
|---|---|
| Female | 25 |
| Male | 7 |
| Ethnicity (NIH/OMB)(Participants) | Batoclimab |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 30 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Batoclimab |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 2 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 30 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
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Studies of the drug tested here: HBM9161
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