QYUNS-B(02509): Phase III clinical study results of Otokibart (QX005N) for prurigo nodularis presented as a late-breaking oral presentation at EADV 2026

QYUNS-B(02509) announced that recently, the results of a China Phase III clinical study of Otokibart (QX005N) for the treatment of prurigo nodularis (PN) were successfully selected for the Late Breaking News (LBN) session of the 35th European Academy of Dermatology and Venereology Congress (EADV Congress 2026) held in Vienna, Austria, and were presented as an oral presentation. The EADV Congress is one of the largest international conferences in Europe and the most influential in the field of dermatology and venereology. This study is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study. Professor Zhang Jianzhong from Peking University People's Hospital presented the study results on behalf of the research team during the conference. The study included a 52-week treatment period (a 24-week double-blind treatment period and a 28-week open-label treatment period) and an 8-week safety follow-up period. A total of 412 patients were enrolled across 62 clinical research centers in China and were randomly assigned in a 1:1 ratio to the 450 mg Otokibart group or the placebo group (subcutaneous administration, once every two weeks). The primary endpoint of this study was the proportion of subjects with a 4-point reduction from baseline in the weekly average Worst Itch Numeric Rating Scale (WI-NRS) score at Week 24, and the key secondary endpoint was the proportion of subjects with an Investigator's Global Assessment - Prurigo Nodularis Stage (IGA PN-S) score of "0" or "1" at Week 24. The study results showed that Otokibart demonstrated sustained and multidimensional clear clinical benefits in itch control, lesion clearance, and improvement in quality of life and mental state in adults with moderate-to-severe PN who had inadequate response to topical drugs such as moderate-to-potent topical corticosteroids (TCS) or for whom TCS treatment was inappropriate, with good safety and tolerability.