A Phase IIIb, Multicentre, Interventional, Randomised, Placebo-Controlled Clinical Trial Investigating the Efficacy and Safety of Guselkumab for the Treatment of Nonpustular Palmoplantar Psoriasis (G-PLUS)

Figure 1

G-PLUS trial design. The trial comprised a placebo-controlled, double-blind period (weeks 0–16), an open-label active treatment phase (weeks 16–48), with participants initially receiving placebo crossing over to receive guselkumab starting at week 16 and through week 48 (last dose of trial intervention was administered at week 44) and an additional 12-week safety follow-up period from week 48 through week 56. An interactive web response system based on randomly permutated blocks was used for central randomisation (2 : 1 guselkumab : placebo). Participants received guselkumab 100 mg at weeks 0, 4, and 12, and q8w thereafter through week 44 or placebo at weeks 0, 4, and 12, followed by guselkumab at weeks 16 and 20, and q8w thereafter through week 44 (referred to as the placebo-crossover group). To maintain blinding, matching placebo was used. PE, primary endpoint; q8w, every 8 weeks; R, randomisation; SE, secondary endpoint.