The Phase 3 clinical trial for Batoclimab in participants with active Thyroid Eye Disease reached its primary completion on 2026-02-03. This milestone signifies that data collection for the study's primary endpoint has concluded, with results anticipated following analysis.
Background
Thyroid Eye Disease is an autoimmune condition affecting the eyes and surrounding tissues, often associated with thyroid dysfunction. It can lead to inflammation, swelling, and changes in eye appearance, including proptosis (bulging eyes).
Trial design
This completed Phase 3 trial (NCT05524571) enrolled 86 participants to assess Batoclimab in individuals with active Thyroid Eye Disease. The study's primary objective was to evaluate the efficacy of batoclimab 680 milligrams (mg) subcutaneous (SC) once a week (QW) for 12 weeks, followed by 340 mg SC QW for 12 weeks, compared to placebo. The primary endpoint was the proptosis responder rate at Week 24.
What this means
The primary completion of this Phase 3 trial for Batoclimab indicates that all necessary data for the main outcome measure has been collected. Clinicians and researchers will now await the detailed analysis of this data to understand the potential efficacy and safety profile of Batoclimab in treating active Thyroid Eye Disease.
Source
Information regarding the primary completion of this trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The update for study NCT05524571, titled "Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease," was posted on 2026-02-03 on clinicaltrials.gov.