AbbVie posts results from terminated emraclidine trial, opens two studies to recruitment

AbbVie posted new trial data and registry updates across four studies this week.

• AbbVie posted results for a Phase 2 open-label trial of emraclidine (CVL-231, ABBV-1231) in adults with schizophrenia. The 52-week trial was terminated, with the sponsor stating the study "was terminated due to business reasons, not safety reasons."¹ The trial had an actual enrollment of 698 participants¹ and tracked outcomes including treatment-emergent adverse events, defined as any untoward medical occurrence in a participant given a pharmaceutical product regardless of causal relationship to treatment.¹
• A Phase 3 trial of upadacitinib in pediatric patients with severe alopecia areata is now recruiting. The study will enroll participants with severe alopecia areata and a SALT score of 50 or higher scalp hair loss, with approximately 300 participants planned across roughly 120 sites worldwide.² Its primary endpoint is the percentage of participants achieving a SALT score of 20 or less at Week 24.²
• A Phase 2 master protocol study of telisotuzumab adizutecan in pancreatobiliary cancers is now recruiting. The trial will test telisotuzumab adizutecan in combination with gemcitabine and nab-paclitaxel in adults with pancreatobiliary cancers,³ with approximately 168 participants planned across about 50 sites worldwide.³
• An observational ovarian cancer biomarker study, MOANA, is registered but not yet recruiting. Sponsored by the Latin American Cooperative Oncology Group with AbbVie as a collaborator, the study will describe overlap of expression of folate receptor alpha (FRα), HER2 and PD-L1 using immunohistochemistry, and HRD and BRCA status by NGS,⁴ drawing on an estimated 320 participants.⁴