IMVT-1401-3201: A Phase 3, Multi-center, Randomized, Quadruple-masked, Placebo-controlled Study of Batoclimab for the Treatment of Participants with Active Thyroid Eye Disease (TED)
Primary Objective
To evaluate the efficacy of batoclimab 680 mg subcutaneously (SC) once a week (QW) for 12 weeks followed by 340 mg SC QW for 12 weeks versus placebo on proptosis responder rate at Week 24
Description
Study IMVT-1401-3201 is a Phase 3, multi-center, randomized, quadruple‑masked (Sponsor, Investigator, assessor, and participant), placebo‑controlled study was designed to assess the efficacy and safety of batoclimab in adult participants with active, moderate to severe TED. The study duration for an individual participant may be up to 32 weeks.
Details
Locations
University of Colorado Hospital
Principal Investigator
Prem Subramanian
Study ID
Protocol Number: 22-1591
More information available at ClinicalTrials.gov: NCT05517421
Categories
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