A multicenter, randomized, double-blinded, placebo-controlled, dose-ranging study evaluating the efficacy and safety of vunakizumab in patients with moderate-to-severe plaque psoriasis.

Background: Vunakizumab (SHR-1314) is a novel interleukin 17A monoclonal antibody that has shown preliminary efficacy and tolerability in phase I trials.
Objective: To evaluate the efficacy and safety of vunakizumab in moderate-to-severe plaque psoriasis.
Methods: In this 36-week, multicenter, double-blinded, phase II study (NCT03463187), 187 eligible patients with moderate-to-severe plaque psoriasis were randomized 1:1:1:1:1 to receive vunakizumab (40, 80, 160, or 240 mg) or placebo subcutaneously, every 4 weeks, until week 12 (2 more drug administrations for the vunakizumab groups on weeks 16 and 20). The primary end point was at least 75% improvement in the Psoriasis Area and Severity Index at week 12.
Results: At week 12, there were significantly greater proportions of responders with at least 75% improvement in the Psoriasis Area and Severity Index in all vunakizumab groups compared to placebo (40, 80, 160, and 240 mg: 56.8%, 65.8%, 81.6%, and 86.5%, respectively, vs 5.4%; P < .001 for all); the proportions of patients achieving Physician's Global Assessment responses of 0 or 1 were also higher with vunakizumab (45.9%, 47.4%, 60.5%, and 73.0%, respectively, vs 8.1%). No unexpected adverse effects were observed.
Limitations: The study was relatively short in duration and included no active control.
Conclusion: Vunakizumab showed promising efficacy for moderate-to-severe plaque psoriasis, with good tolerability, warranting further investigation in larger and longer-term studies.
Competing Interests: Conflicts of interest Dr Sinclair is the director and founder of Samson Medical Pty Ltd, serves on the advisory boards of Eli Lilly and Company, Pfizer Inc, and Leo Pharmaceutical, and has been a speaker for Abbvie and Novartis and a principal investigator in clinical trials for AbbVie, Aerotech, Akesobio, Amgen, Arcutis, Arena, Ascend AstraZeneca, Bayer AG, Biotherapeutics Boehringer Ingelheim, Bristol Myer Squibb, Celgene, Coherus BioSciences, Connect, Demira, Eli Lilly and Company, Galderma, Glaxo Smith Kline, F. Hoffman–La Roche, Janssen, MedImmune, Merck and Co, Merck Sharpe & Dohme, Novartis, Oncobiologics, Pfizer, Principia, Regeneron, Roche, Reistone Biopharma, Samson Clinical, Sanofi-Genzyme, and Sun Pharma UCB. Author Zhu and Dr Qian Xu were employees of Hengrui Pharmaceuticals at the time of the study. Drs Zhang, Yan, Diao, Guo, Jin, Yang, Chen, Lei, Wu, Yu, Zheng, Gao, and Jinhua Xu have no conflicts of interest to declare.
(Copyright © 2022 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.)