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Batoclimab · 2 trials · 1 indication
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.
| 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 |
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 an investigational small molecule being developed for the treatment of Thyroid Eye Disease, an endocrine condition. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities. Two Phase 3 trials have been completed to assess its safety and efficacy in patients with active Thyroid Eye Disease.
Batoclimab targets the neonatal Fc receptor, which plays a role in regulating antibody levels in the body. By blocking this receptor, the drug is designed to reduce pathogenic IgG antibodies that contribute to the inflammation and tissue changes seen in Thyroid Eye Disease. This mechanism is being evaluated in clinical trials.
Batoclimab is being developed by Immunovant, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol IMVT. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Thyroid Eye Disease.
Batoclimab is in Phase 3 clinical development for Thyroid Eye Disease. Two Phase 3 trials have been completed, with a total enrollment of 200 participants. The drug is investigational and has not yet received regulatory approval, meaning it remains in clinical development.
Batoclimab has been studied in two completed Phase 3 trials: NCT05517421, which enrolled 114 participants, and NCT05524571, which enrolled 86 participants. Both trials assessed the drug in patients with active Thyroid Eye Disease and were randomized, double-blind, and placebo-controlled. The trials were conducted across multiple countries, including the United States, Germany, Japan, and the United Kingdom.