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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)

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


Why this Research Matters

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.


Who can Participate

Adult

The study population will consist of participants 18 years or older who have active, moderate to severe TED.


Study ID

Protocol Number: 22-1591
More information available at ClinicalTrials.gov: NCT05517421

Meet the Team

Image of Principal Investigator

Prem Subramanian, MD, PhD

Principal Investigator