GSK registers three new Phase 3 trials spanning asthma, prostate cancer, ovarian cancer
GSK's registry activity this week includes three new Phase 3 studies, two earlier-phase trials, and an observational pregnancy registry for gepotidacin.
GSK's registry entries this week are led by three newly listed Phase 3 trials, alongside a completed Phase 1 drug-interaction study, an active vaccine trial, a not-yet-recruiting lupus study, a GIST legacy study, and a new pregnancy exposure registry.
- GlaxoSmithKline is the lead sponsor of "PERSIST ASTHMA-2," a Phase 3 trial testing GSK5784283 (felcorekibart) as add-on therapy in adults and adolescents with uncontrolled asthma. The study is recruiting with an actual start date of August 27, 20261, and plans to enroll 370 participants1, with the annualized rate of clinically significant asthma exacerbations measured up to Week 52 as the primary outcome1.
- GSK is also the lead sponsor of "EMBOLD Prostate-302," a Phase 3 trial of risvutatug rezetecan (Ris-Rez), a B7-H3 antibody drug conjugate, in metastatic castration-resistant prostate cancer. The study is recruiting and evaluates how well Ris-Rez works compared to best supportive/standard of care2, with planned enrollment of 684 participants2 and radiographic progression-free survival per PCWG3 by blinded independent central review as the primary outcome2.
- GSK is the lead sponsor of "BEHOLD-Ovarian02," a Phase 3 trial of mocertatug rezetecan (Mo-Rez) combined with bevacizumab versus platinum doublet chemotherapy plus bevacizumab in platinum-sensitive ovarian cancer. The trial is recruiting and assesses whether Mo-Rez plus bevacizumab works better than standard treatments in shrinking tumors or extending survival3, with 690 participants planned3.
- A Phase 2 proof-of-concept trial called "Bela-SLE" is not yet recruiting; GlaxoSmithKline is listed as a collaborator while the lead sponsor is the Medical Association for the Study of Cancer Biology and Treatment. The trial's primary objective is to evaluate the effect of adding belantamab mafodotin to standard of care therapy on serum anti-dsDNA antibody titres in patients with previously treated SLE4, with 12 participants planned4.
- GSK is the lead sponsor of a Phase 2 legacy study offering continued velzatinib (GSK6042981) treatment to adults with gastrointestinal stromal tumors who completed a parent study. The study is not yet recruiting and aims to evaluate the long-term safety and tolerability of velzatinib in adults with GIST who previously received the drug and continue to benefit from treatment5, with 72 participants planned5.
- A Phase 1 drug-interaction study of GSK3772701 has completed. The study evaluated whether GSK3772701 alters the pharmacokinetics of midazolam, a standard probe substrate for the CYP3A4 enzyme6, enrolling 20 healthy participants6 with a primary completion date of August 24, 2026.
- A Phase 1 pneumococcal vaccine booster trial in toddlers is active, not recruiting. The study assesses the safety and reactogenicity of a single dose of the investigational vaccine Pn-MAPS30plus in toddlers who previously completed a two-dose PCV primary series, using PCV20 as a comparator7, with 46 participants enrolled7.
- GSK is the lead sponsor of the "Prospective Registry of Exposure to Gepotidacin" (PREG), an observational study that is not yet recruiting. The registry will monitor pregnancies exposed to gepotidacin to evaluate possible teratogenic or birthweight-lowering effects, focusing on major congenital malformations and small-for-gestational-age births8, with 614 participants planned8.
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.