Dermatology and therapy · 2026
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.
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Wu Chao, Niu Xuping, Wang Xiaohua, Su Juan, Zhao Hengguang, Lin Mao, Yang Chunjun, Qin Xiaoming, Guo Shuping, Jiang Cunhuo, Tang Hui, Yang Haijing, Wu Liming, Zhu Min, Wei Aihua, Tao Xiaohua, Zhang Yiwen, Shu Chang, Liu Jiawei, Yang Lu, Qian Yuetong, Zhang Bingjie, Zhang Shiyu, Xu Junfang, Lu Yang, Peng Mingjia, Luo Shizheng, Ma Weijie, Jin Hongzhong
Аннотация
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).
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).