Novartis’ Cosentyx Fails to Meet Primary Endpoint in GCAptAIN Study for Giant Cell Arteritis

Novartis' Cosentyx Fails to Meet Primary Endpoint in GCAptAIN Study for Giant Cell Arteritis

Swiss pharmaceutical giant Novartis (NYSE: NVS) announced this week that its Phase III GCAptAIN study for Cosentyx (secukinumab) in adults with newly diagnosed or relapsing giant cell arteritis (GCA) did not meet its primary endpoint. This marks a setback for the company as it explores new indications for the IL-17A inhibitor.

Study Details and Results
The GCAptAIN trial evaluated the efficacy and safety of secukinumab in combination with a 26-week glucocorticoid tapering regimen, compared to placebo plus glucocorticoid tapering. Results indicated that secukinumab did not show a statistically significant improvement over placebo in achieving sustained remission at 52 weeks. Secondary endpoints also did not achieve statistical significance, though numerical trends suggested secukinumab may help reduce cumulative glucocorticoid dose and related toxicity.

Safety Profile
The safety profile of secukinumab in the GCAptAIN trial remained consistent with previous findings, supporting its established safety profile across other indications.-Fineline Info & Tech