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Introduction <p>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.</p> Methods <p>This phase&#xa0;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.</p> Results <p>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&#xa0;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.</p> Conclusions <p>HDM3010 demonstrated a favorable safety profile, minimal systemic exposure, and positive trends in reducing pruritus and lesions in adults with PN.</p> Trial Registration <p>Chinese Clinical Trial Registry (<a href="http://www.chictr.org.cn">http://www.chictr.org.cn</a>): ChiCTR2500096434 (registered January 23, 2025).</p>

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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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年5月18日

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  • 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

摘要

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).