Safety, Pharmacokinetics, and Efficacy of 1.5% Ruxolitinib Gel (HDM3010) in Adult Patients with Prurigo Nodularis: A Phase I/II, Randomized, Double-Blind, Vehicle-Controlled Multicenter Clinical Trial
Year: 2026
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: INTRODUCTION: Prurigo nodularis (PN) is a chronic inflammatory dermatosis with severe, persistent pruritus and limited effective therapies. Janus kinase (JAK) inhibition has emerged as a targeted strategy for PN. METHODS: This phase I/II, randomized, double-blind, vehicle-controlled, multicenter clinical trial was conducted in China to evaluate the safety, pharmacokinetics, and efficacy of topical 1.5% ruxolitinib gel (HDM3010) in adults with PN. Adult patients with PN were randomized 2:1 to receive HDM3010 or vehicle, administered once daily (QD) or twice daily (BID), during a 4-week double-blind treatment period. RESULTS: Forty-nine patients were randomized. HDM3010 demonstrated a safety profile characterized by treatment-emergent adverse events in 18.8% of QD and 25.0% of BID patients, compared with 12.5% of vehicle QD and 55.6% of vehicle BID patients. Treatment-related adverse events were infrequent (4.1%) and limited to mild-to-moderate severity. Pharmacokinetic analyses showed low systemic exposure, with mean peak plasma concentrations below 7 ng/mL at steady state. Compared with vehicle, HDM3010 was associated with higher proportions of ≥ 4-point Worst Itch Numerical Rating Scale (WI-NRS) responders and greater improvements in WI-NRS, Investigator's Global Assessment for Prurigo Nodularis-Stage (IGA PN-S), and Investigator's Global Assessment for Prurigo Nodularis-Activity (IGA PN-A) scores. CONCLUSIONS: HDM3010 demonstrated a favorable safety profile, minimal systemic exposure, and positive trends in reducing pruritus and lesions in adults with PN. TRIAL REGISTRATION: Chinese Clinical Trial Registry ( http://www.chictr.org.cn ): ChiCTR2500096434 (registered January 23, 2025).
Source: Dermatology and Therapy
Authors: Chao Wu, Xuping Niu, Xiaohua Wang, Juan Su, Hengguang Zhao, Mao Lin, Chunjun Yang, Xiaoming Qin, Shuping Guo, Cunhuo Jiang, Hui Tang, Haijing Yang, Liming Wu, Min Zhu, Aihua Wei, Xiaohua Tao, Yiwen Zhang, Chang Shu, Jiawei Liu, Lu Yang, Yuetong Qian, Bingjie Zhang, Shiyu Zhang, Junfang Xu, Yang Lu, Mingjia Peng, Shizheng Luo, Weijie Ma, Hongzhong Jin
Institutions: Chinese Academy of Medical Sciences & Peking Union Medical College, Peking Union Medical College Hospital, Taiyuan Central Hospital, Southern Medical University, Central South University, Xiangya Hospital Central South University, Second Affiliated Hospital of Chongqing Medical University, Sichuan University, West China Hospital of Sichuan University, Anhui Medical University, Second Affiliated Hospital of Anhui Medical University, Wannan Medical College, Shanxi Medical University, First Hospital of Shanxi Medical University, Chengdu Second People's Hospital, Fudan University, Huashan Hospital, Westlake University, Affiliated Hangzhou First People's Hospital, Westlake University, School of Medicine, Guangxi University of Chinese Medicine, Beijing Tongren Hospital, Capital Medical University, Zhejiang Provincial People's Hospital, Hangzhou Medical College
Language: English
Subfield: Dermatology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $7,400
Awards: G5230926456, G7426023155, G8070852934
OpenAlex ID: W7161578451