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Wednesday, July 2, 2025

Novartis Phase III Cosentyx Trial Misses Primary Endpoint



Novartis (NYSE:NVS) announced that its Phase III GCAptAIN study of Cosentyx® (secukinumab) in giant cell arteritis (GCA) did not meet its primary endpoint of sustained remission at Week 52. The study evaluated Cosentyx in combination with a 26-week steroid taper versus placebo with a 52-week steroid taper in adults with newly diagnosed or relapsing GCA.

While secondary outcomes showed numerically better results for cumulative steroid dose and steroid-related toxicity compared to placebo, they did not achieve statistical superiority. The safety profile remained consistent with Cosentyx's known safety data across approved indications. Novartis plans to conduct a full evaluation of the study data and share detailed results in the future.

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