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Innovent Announces Phase 3 RESTORE-3 Study of SYCUME® (Teprotumumab N01 Injection) Met Primary Endpoint in Inactive Thyroid Eye Disease
- Innovent announced that SYCUME® met the primary endpoint at Week 24 in the Phase 3 RESTORE-3 study involving Chinese participants with inactive thyroid eye disease.
- The randomized, double-blind, placebo-controlled trial evaluated SYCUME®’s effectiveness and safety in this patient group.
- At Week 24, the proptosis response rate was 60.4% with SYCUME®, compared with 23.5% with placebo, a 36.9-percentage-point difference.
- Innovent reported that SYCUME® showed good safety and tolerability during treatment and follow-up.
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Innovent Announces Phase 3 RESTORE-3 Study of SYCUME® (Teprotumumab N01 Injection) Met Primary Endpoint in Inactive Thyroid Eye Disease
SYCUME® Significantly Improved Proptosis (Response Rate 60.4% / LS Mean Change from Baseline -1.88 mm) with Favorable Safety Profile in Participants with Inactive Thyroid Eye Disease(TED)
Innovent's Sycume Meets Primary Endpoint in Phase 3 Trial for Inactive Thyroid Eye Disease (TED)
Key Takeaways Sycume (IBI311) met the primary endpoint of the phase 3 RESTORE-3 trial, achieving a 60.4% proptosis response rate at Week 24 compared with 23.5% for placebo in patients with inactive thyroid eye disease Treatment resulted in statistically significant reductions in proptosis in both study and non-study eyes, with most treatment-emergent adverse events reported as mild to moderate and no new safety signals identified The fin…
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