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Also known as IMVT-1401
Batoclimab · 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...
Batoclimab is being developed for the treatment of active thyroid eye disease, an autoimmune condition affecting the tissue around the eyes. It is an investigational monoclonal antibody in Phase 3 clinical development and has not been approved for commercial use.
Batoclimab targets FCGRT, the neonatal Fc receptor, and acts as an inhibitor. By binding this receptor, the drug is designed to reduce circulating immunoglobulin G antibodies, a mechanism relevant to autoimmune conditions such as thyroid eye disease.
Batoclimab is being developed by Immunovant, Inc., which trades on the Nasdaq under the ticker IMVT. The company is the sponsor of the clinical program evaluating the drug in thyroid eye disease.
Batoclimab is in Phase 3 clinical development for thyroid eye disease. It is an investigational therapy and is not FDA approved. Two Phase 3 trials have been completed, and no active trials are currently listed for the program.
Batoclimab has been studied in two completed Phase 3 trials: NCT05524571, which enrolled 86 participants, and NCT05517421, which enrolled 114 participants. Both were randomized, double-blind, placebo-controlled studies in adults with active thyroid eye disease across multiple countries.
The two completed Phase 3 trials of batoclimab enrolled a total of 200 participants. NCT05524571 enrolled 86 patients and NCT05517421 enrolled 114 patients, all adults aged 18 years and older with active thyroid eye disease.