Novartis updates Phase IIIb ribociclib adjuvant breast cancer trial; four prior items hold

Novartis's weekly registry activity is led by an update to its Phase IIIb ribociclib trial in early breast cancer, with four previously reported studies unchanged.

• The Phase IIIb "Adjuvant WIDER" study (NCT05827081) of ribociclib plus endocrine therapy in HR+, HER2- early breast cancer was updated and is now listed as active, not recruiting. The open-label, multicenter, single-arm study is designed to characterize the efficacy and safety of ribociclib plus standard adjuvant endocrine therapy on invasive breast cancer-free survival in a close-to-clinical-practice population with HR-positive, HER2-negative early breast cancer.¹ The study enrolled 1,464 participants.¹
• The Japan observational study of intrathecal Zolgensma (onasemnogene abeparvovec) in spinal muscular atrophy (NCT07767890) remains recruiting. The study aims to assess the safety and effectiveness of onasemnogene abeparvovec intrathecal injection in SMA patients in clinical practice in Japan,² with an estimated 80 participants.
• The managed access program listing for MAS825 (arumakimig) in Still's disease (NCT07889310) remains "temporarily not available." The registration is meant to list Managed Access Programs providing access to MAS825 for patients with Still's disease, including SJIA and AOSD, with MAS or ILD complications.³
• The UAE hypertension study of ARNi therapy (NCT07465666, REAL-HTN) remains recruiting. The study aims to evaluate the real-world effectiveness of ARNi (sacubitril/valsartan) therapy and antihypertensive monotherapy in reducing blood pressure in hypertensive patients residing in the United Arab Emirates,⁴ with an estimated enrollment of 500 participants.
• The US claims-based psoriasis study on secukinumab retention (NCT07881783, STAY SEC PsO) remains not yet recruiting. The study aims to assess whether secukinumab treatment retention over 12 months in adult patients with moderate-to-severe plaque psoriasis receiving secukinumab with a GLP-1 receptor agonist is non-inferior to retention with secukinumab monotherapy,⁵ with an estimated enrollment of 3,718 participants.