Karuna/BMS opens Phase 3 KarXT relapse prevention trial in schizophrenia

This week brings a newly recruiting Phase 3 schizophrenia trial and a completed observational myeloma study, both tied to Bristol Myers Squibb.

• Karuna Therapeutics, a Bristol Myers Squibb company, is recruiting for a Phase 3 trial titled "A Phase 3 Double-blind, Placebo-controlled Randomized Withdrawal Maintenance Trial of KarXT Treatment in Participants With Schizophrenia" (NCT07686263). The purpose of the study is to evaluate the relapse prevention of KarXT in the treatment of participants with Schizophrenia.¹ The trial plans to enroll 472 participants, with a start date of 2026-08-20 and primary completion estimated for 2029-03-03.¹ The primary outcome is time from randomization to the first relapse event, measured up to approximately Week 43.¹
• Bristol-Myers Squibb completed a retrospective observational study titled "Analysis of Clinical Outcomes in Patients With Relapsed/Refractory Multiple Myeloma Receiving Pomalidomide-Containing and Non-Pomalidomide-Containing Regimens in the Real World: A OneOncology United States Database Study" (NCT07689006). The study enrolled 341 participants and reached study completion on 2025-03-28, comparing Participants who initiated daratumumab, pomalidomide, and dexamethasone (DPd) or carfilzomib, pomalidomide, and dexamethasone (KPd) index regimens in the 2L or 3L setting after prior exposure to lenalidomide and a proteasome inhibitor² against non-pomalidomide-based regimens, with primary outcomes including Progression-Free Survival (PFS), Overall Survival (OS), Overall Response Rate (ORR), and Time to Next Treatment (TTNT) among participants who initiated pomalidomide-containing index regimens.²