Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as IMVT-1401 (batoclimab), Batoclimab
IMVT-1401 · 3 trials · 2 indications
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.
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 be administered batoclimab 680 mg SC weekly for 12 weeks followed by 340 mg SC weekly for 12 weeks. |
| Placebo | PLACEBO_COMPARATOR | Participants will be administered matching placebo SC weekly for 24 weeks. |
| Name | Type | Description |
|---|---|---|
| Batoclimab | DRUG | Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody |
| Placebo | DRUG | Matching Placebo |
| IMVT-1401 (batoclimab) | DRUG | Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody. |
Inclusion criteria: 1. Are ≥18 years of age at screening. 2. 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 a...
IMVT-1401 is an investigational monoclonal antibody being studied for the treatment of Graves Disease, an autoimmune thyroid condition. It was evaluated in a Phase 2 proof-of-concept study in participants with Graves Disease. It is not approved for any use and remains in clinical development.
IMVT-1401 targets the neonatal Fc receptor, or FcRn, a protein that recycles immunoglobulin G antibodies and extends their half-life in circulation. By binding FcRn, the antibody is designed to reduce circulating IgG levels, including the autoantibodies implicated in Graves Disease. It is a monoclonal antibody modality.
IMVT-1401 is being developed by Immunovant, Inc., which trades on the Nasdaq under the ticker IMVT. Immunovant is the sponsor of the clinical program evaluating the drug in Graves Disease.
IMVT-1401 is in Phase 2 development. Its Graves Disease program consists of a single Phase 2 proof-of-concept study, which is now completed. The drug is investigational and has not been approved by the FDA for Graves Disease or any other indication.
IMVT-1401 has been studied in one clinical trial, NCT05907668, titled a proof-of-concept study to assess batoclimab in participants with Graves Disease. That Phase 2 trial enrolled 32 participants in Germany, included adults 18 years and older, and is completed. It was an uncontrolled study without randomization or blinding.
Yes. IMVT-1401 is also known as batoclimab. The two names refer to the same investigational monoclonal antibody developed by Immunovant, and the Graves Disease trial is listed under the batoclimab name.