Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IMVT-1401 · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| 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. |
| Name | Type | Description |
|---|---|---|
| IMVT-1401 (batoclimab) | DRUG | Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody. |
Inclusion Criteria: * 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 ...
IMVT-1401 is an investigational small molecule being developed for the treatment of Graves Disease, an endocrine condition. It is currently in Phase 2 clinical development. The drug is being studied to assess its potential as a therapy for this autoimmune disorder, though it is not yet approved for any use.
IMVT-1401 is being developed by Immunovant, Inc., a biopharmaceutical company. The company's stock is listed under the ticker symbol IMVT. Immunovant is responsible for the clinical development and regulatory strategy for this investigational drug.
IMVT-1401 is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being evaluated for its safety and efficacy in patients with Graves Disease, and it remains in active clinical testing.
IMVT-1401 has one completed Phase 2 clinical trial, identified as NCT05907668. This proof-of-concept study assessed the drug in 32 participants with Graves Disease in Germany. The trial was uncontrolled, meaning there was no placebo or comparator group, and it enrolled adults aged 18 years and older.
Yes, IMVT-1401 is also known as batoclimab. The clinical trial NCT05907668, which assessed the drug in Graves Disease, is titled 'A Proof-of-Concept Study to Assess Batoclimab in Participants With Graves' Disease.' Both names refer to the same investigational drug.