Study overview

IMVT-1401-3201 was a multicenter, randomized, quadruple-masked, placebo-controlled Phase 3 study of batoclimab for active thyroid eye disease. The registered study compared subcutaneous batoclimab with placebo and evaluated response after the protocol-defined treatment period. The ClinicalTrials.gov record lists the study as completed, so this page is educational and must not be interpreted as an invitation to enroll in that completed protocol.

What researchers are evaluating

The primary evaluation focused on proptosis response, which measures forward displacement of the eye associated with thyroid eye disease. Researchers also monitored safety, tolerability, eye findings, symptoms, laboratory results, and other protocol-defined outcomes. Masking limited knowledge of treatment assignment among participants and study personnel to reduce bias. Batoclimab was investigational in this setting, and the study was designed to add evidence about its effects and risks rather than guarantee benefit to any participant.

Considering participation

Although this protocol is completed, CRI staff may provide general information about the study record or explain whether other research opportunities are available. Availability of another study depends on its own status, location, and eligibility criteria. No website summary can determine whether a person qualifies for research or whether a treatment is appropriate. Participation in any future study is voluntary and requires a separate screening and informed-consent process. A research team would explain procedures, visits, foreseeable risks, possible benefits, alternatives, privacy protections, and participant rights before enrollment. Continue medical care with a qualified eye-care or thyroid clinician and seek urgent care for emergency symptoms. Do not include medical records, photographs, insurance data, or sensitive health information in an initial inquiry.

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