The Phase 3 extension study (NCT05517447) investigating batoclimab for participants with Thyroid Eye Disease completed its primary phase on April 2, 2026. This study, which enrolled 109 participants, aimed to assess the durability of proptosis response or the efficacy of batoclimab. The study's overall status is currently listed as terminated.
Background
Batoclimab was investigated in an extension study for Thyroid Eye Disease, a condition characterized by inflammation and damage to tissues around the eyes. This particular study was designed as an extension for participants who had completed prior feeder studies, specifically IMVT-1401-3201 or IMVT-1401-3202.
Trial design
The Phase 3 extension study (NCT05517447) was a 2-cohort study that enrolled 109 participants with Thyroid Eye Disease. It included an observational cohort designed to assess the durability of proptosis response from feeder studies off treatment. Additionally, a treatment cohort was included to evaluate the efficacy of batoclimab, as assessed by proptosis responder rate. The study served as an extension for participants completing previous studies (IMVT-1401-3201 or IMVT-1401-3202).
What this means
The primary completion of the Phase 3 extension study for batoclimab indicates that the planned data collection for its primary objectives has concluded. While the study's overall status is listed as terminated, the completion of its primary phase suggests that data on the durability of proptosis response or the efficacy of batoclimab in Thyroid Eye Disease will be analyzed and potentially reported. Further details on the reasons for termination and the study's findings are anticipated.
Source
The information regarding the primary completion of this trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The study record for NCT05517447, titled "Extension Study to Assess Batoclimab in Participants With Thyroid Eye Disease," was updated on April 2, 2026, on clinicaltrials.gov.