Janssen Research & Development announced results from the Phase 2b X-PLORE trial with guselkumab in patients with moderate to severe plaque psoriasis.
X-PLORE is a randomized, placebo- and active comparator-controlled, parallel-group, multicenter dose-ranging study which evaluated subcutaneous injections of five doses of guselkumab compared with placebo and adalimumab in patients with moderate to severe plaque psoriasis, who are candidates for systemic or phototherapy. Patients (n=293) were randomized in the seven-arm study to receive placebo, guselkumab (five dose groups), or adalimumab. The primary endpoint was the proportion of patients who achieve a Physician's Global Assessment (PGA) score of cleared (0) or minimal (1) at Week 16.
At Week 16, significantly higher proportions of guselkumab-treated patients achieved PGA 0 or 1 compared with patients receiving placebo across all dose groups: 34% (5mg); 61% (15 mg); 79% (50 mg); 86% (100mg); 83% (200mg); 7% (placebo group) [P=0.002 for 5mg; P<0.001 for all other doses].
After Week 16, the proportions of guselkumab-treated patients achieving a PGA score of 0 or 1 remained consistent or showed additional improvement. Moreover, complete clearance (PGA 0) was observed in 62% of patients in the guselkumab 100mg dose group after 40 weeks of continuous treatment.
Guselkumab is a human monoclonal antibody with a novel mechanism of action that targets the protein interleukin (IL)-23. It is currently in Phase 3 clinical development as a subcutaneously administered therapy for the treatment of moderate to severe plaque psoriasis.