VRDN-003-301: A phase 3, randomized, double-masked, placebo-controlled, efficacy, safety, and tolerability study of VRDN-003 in participants with active thyroid eye disease (TED)

Thyroid eye disease

The primary study endpoint will assess the percentage of participants who have a response called Overall Responder Rate at Week 24. An Overall Responder is a participant who achieves a ≥ 2 mm reduction in eye bulging AND shows a reduction in Clinical Activity Score or CAS (that is an estimate of disease severity/symptoms) ≥ 2 points at Week 24 versus measurements before the first dose.

The secondary endpoints will assess changes in eye bulging, disease severity and symptoms versus measurements before the first dose, and percent of participants who achieve the required reduction in eye bulging, disease severity and symptoms, and reduction and resolution of double vision at Week 24., Safety Endpoint: the study will also evaluate safety events (side effects), the effects of VRDN-003 on the body and vice-versa throughout the study.

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