Novartis roundup: ITP real-world data completed; three trials registered; Utah study terminated
A week of Novartis-linked registry activity spans a completed observational ITP study, new Phase 1 and Phase 2 registrations, and an investigator-led terminated trial.
This week's Novartis-related clinical trial registry activity included one completed real-world study, several newly posted trials, and one terminated academic study.
- A University of Utah-sponsored Phase I/Ib trial combining ribociclib and belinostat in metastatic triple-negative breast cancer and recurrent ovarian cancer, with Novartis as a collaborator, was terminated. The trial (NCT04315233, acronym CHARGE) was terminated due to no accrual in one year.1
- Novartis Pharmaceuticals completed a retrospective real-world study of primary immune thrombocytopenia patients. The study described real-world treatment patterns and standard of care effectiveness in adult primary ITP patients indicated for second-line treatment after prior corticosteroid use, using U.S. electronic health record and claims data.2 Enrollment reached 3714 participants.2
- Novartis Pharmaceuticals registered a Phase 2a/b trial of DDY391 in psoriatic arthritis, now recruiting. The study aims to evaluate the efficacy, safety and tolerability of DDY391 in participants with psoriatic arthritis, and to determine its dose-response relationship to support Phase 3 dose selection.3 Planned enrollment is 220 participants.3
- Novartis Pharmaceuticals registered a Phase I imaging study of the radioligand [68Ga]Ga-DWJ155 (also known as FKL480), now recruiting. The study evaluates imaging characteristics, safety, biodistribution and pharmacokinetics of the agent in patients with advanced gastroesophageal adenocarcinoma, HR+/HER2- and HER2+ advanced breast cancer, triple-negative breast cancer, and advanced non-small cell lung cancer.4 Estimated enrollment is 66 participants.4
- Novartis Korea Ltd. is a collaborator on a Phase 4 trial evaluating inclisiran added to statin and ezetimibe for coronary plaque stabilization in acute coronary syndrome, sponsored by Seoul National University Bundang Hospital and not yet recruiting. The trial plans to randomize 294 participants 1:1 to an early intensive strategy with a high-intensity statin, ezetimibe, and inclisiran, or a guideline-based stepwise lipid-lowering strategy.5
- Novartis Pharmaceuticals registered a Phase 1 pharmacokinetics study of PKN605 in participants with renal impairment, not yet recruiting. The purpose is to assess potential exposure increases of PKN605 in participants with reduced renal function to support eligibility and dosing decisions in future trials.6 Planned enrollment is 40 participants.6
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.