Novartis posts Cosentyx nail psoriasis and imatinib results; Piqray label updated

Novartis-linked clinicaltrials.gov and FDA records updated this week across results postings, a label change, completed studies, and newly active or registered trials.

• A Phase IV open-label study of secukinumab (Cosentyx) auto-injector in nail psoriasis, sponsored by the University of Pennsylvania with Novartis as a collaborator, posted results. The primary outcome tracked change in the Nail Psoriasis Severity Index (NAPSI) at 24 weeks¹, with an Open Label arm result of -23.7 (spread 14.3) and 0 of 16 participants with serious adverse events¹.
• A Novartis-sponsored Phase IV roll-over study of imatinib mesylate (Glivec/Gleevec) in GIST and CML posted results. The open-label, multicenter study evaluated the long-term safety of imatinib in patients who had completed a previous Novartis-sponsored imatinib study and were considered by the investigator to continue benefiting from treatment², enrolling 155 participants.
• The FDA approved a labeling supplement for Piqray (alpelisib), sponsored by Novartis. The submission, numbered SUPPL 11 and classified as Labeling, was approved with a submission status date of 2026-10-28³.
• A Novartis-sponsored Phase IV study of everolimus (Votubia) in Taiwanese adults with tuberous sclerosis complex and renal angiomyolipoma has completed. The study assessed the safety and efficacy of everolimus in patients with renal AML associated with tuberous sclerosis complex, limited to those meeting local reimbursement criteria⁴, with 4 participants enrolled.
• A Novartis-sponsored Phase 2 trial of iptacopan (LNP023) in early and intermediate age-related macular degeneration has completed. The study assessed whether iptacopan could prevent conversion of early or intermediate AMD eyes to new incomplete retinal pigment epithelium and outer retinal atrophy or to late AMD⁵, with approximately 146 participants planned across the iptacopan and placebo arms⁵.
• A Novartis-sponsored non-interventional study of [177Lu]Lu-PSMA-617 (Pluvicto) in metastatic castration-resistant prostate cancer is recruiting. The study aims to evaluate real-world treatment effectiveness of Pluvicto in both pre- and post-taxane mCRPC patients using data from the United States and Germany⁶, with an estimated enrollment of 1,085 participants.
• Stanford University, with Novartis as a collaborator, continues recruiting a Phase 1b trial of rapcabtagene autoleucel (YTB323) in large B-cell lymphoma. The trial assesses efficacy of rapcabtagene autoleucel in adults with LBCL at high risk of relapse at end of first-line treatment, as defined by positive measurable residual disease⁷, with an estimated enrollment of 20 participants.
• Novartis registered a new qualitative study on adoption of a novel malaria treatment in Côte d'Ivoire, Ghana, and Rwanda, not yet recruiting. The non-interventional study will examine factors influencing adoption through one-time, in-depth interviews with patients, caregivers, healthcare providers, pharmacists, and community health workers who received antimalarial treatment in the past malarial season⁸, with an estimated enrollment of 184 participants.