Safety, Pharmacokinetics, and Efficiency of JS005, a Novel Anti-interleukin-17A Monoclonal Antibody, in Healthy Chinese Adults and Patients with Moderate to Severe Psoriasis

JS005 is a novel anti-IL-17A monoclonal antibody. A Phase Ia study (Study 1) in healthy adults, followed by a Phase Ib/II study (Study 2) in patients with moderate to severe plaque psoriasis (PsO), were designed to evaluate the safety, efficacy, and pharmacokinetic characteristics of JS005. Study 1 was a double-blind, randomized, placebo-controlled, single dose-escalation (15, 60, 150, 300, and 600 mg) study. Forty healthy participants were enrolled. Study 2 consisted of a dose-escalation (60, 150, 300, or 600 mg) phase Ib, and a multicentre, double-blind, placebo-controlled phase II administering JS005 150, 300 mg, or placebo once weekly from week 0 to 4 and once every 4 weeks from week 5 to 12. Forty and 143 patients were enrolled in phases Ib and II, respectively. The exposure of JS005 increased linearly with dosage, while the treatment-emergent adverse events did not show this trend. JS005 was well tolerated in both populations. In phase II of Study 2, the proportion of patients with at least a 75% improvement in the Psoriasis Area and Severity Index at week 12 was significantly higher in each JS005 group than in the placebo group (p < 0.001 for all comparisons). JS005 was highly effective in PsO patients.

Authors

Institutions

Publication Details

Journal
Acta Dermato Venereologica
Published
2025-03-26
DOI
https://doi.org/10.2340/actadv.v105.41105
Citations
1
Primary Topic
Psoriasis: Treatment and Pathogenesis
Type
article
Field-Weighted Citation Impact
0.80
Controls
|||
ALL TIME
JAN
FEB
MAR
APR
MAY
JUN
JUL
AUG
SEP
OCT
article

Safety, Pharmacokinetics, and Efficiency of JS005, a Novel Anti-interleukin-17A Monoclonal Antibody, in Healthy Chinese Adults and Patients with Moderate to Severe Psoriasis

Liu Hui‐chen, Xiuqin Dong, J. Liu, Litao Zhang et al.
1 citations
Acta Dermato Venereologica
Psoriasis: Treatment and Pathogenesis
0.80
article

Safety, Pharmacokinetics, and Efficiency of JS005, a Novel Anti-interleukin-17A Monoclonal Antibody, in Healthy Chinese Adults and Patients with Moderate to Severe Psoriasis

Liu Hui‐chen, Xiuqin Dong, J. Liu, Litao Zhang, Aiming Li, Zhanglei Mu, Xiaohua Tao, Zhijuan Wu, Furen Zhang, Guoqiang Zhang, Jianzhong Zhang, Chunlei Zhang, Yumei Li, Lin Cai, Yixin Zhu, Mengqi Zhang, Aijun Chen, Cheng‐Xin Li
article en
1 citations

Abstract

JS005 is a novel anti-IL-17A monoclonal antibody. A Phase Ia study (Study 1) in healthy adults, followed by a Phase Ib/II study (Study 2) in patients with moderate to severe plaque psoriasis (PsO), were designed to evaluate the safety, efficacy, and pharmacokinetic characteristics of JS005. Study 1 was a double-blind, randomized, placebo-controlled, single dose-escalation (15, 60, 150, 300, and 600 mg) study. Forty healthy participants were enrolled. Study 2 consisted of a dose-escalation (60, 150, 300, or 600 mg) phase Ib, and a multicentre, double-blind, placebo-controlled phase II administering JS005 150, 300 mg, or placebo once weekly from week 0 to 4 and once every 4 weeks from week 5 to 12. Forty and 143 patients were enrolled in phases Ib and II, respectively. The exposure of JS005 increased linearly with dosage, while the treatment-emergent adverse events did not show this trend. JS005 was well tolerated in both populations. In phase II of Study 2, the proportion of patients with at least a 75% improvement in the Psoriasis Area and Severity Index at week 12 was significantly higher in each JS005 group than in the placebo group (p < 0.001 for all comparisons). JS005 was highly effective in PsO patients.

Acta Dermato VenereologicaVol. 105
Hebei Medical University (CN), Jiangsu University (CN), Tianjin University of Traditional Chinese Medicine (CN), Chinese Academy of Medical Sciences & Peking Union Medical College (CN), Peking University (CN), Peking Union Medical College Hospital (CN), Chinese PLA General Hospital (CN), Affiliated Hospital of Jiangsu University (CN), Beijing Luhe Hospital Affiliated to Capital Medical University (CN), Peking University People's Hospital (CN), The Affiliated Yongchuan Hospital of Chongqing Medical University (CN), Zhejiang Provincial People's Hospital (CN), Peking University Third Hospital (CN), Guangdong Provincial People's Hospital (CN), Chongqing Medical University (CN)
Good health and well-being
Openalex Percentile: Top 30%
Psoriasis: Treatment and Pathogenesis
0.80
DOIOpen Access PDFOpenAlex
AI Navigator

Ask Laika to Summarize, Analyze, and Connect papers live on the map.

Summarize Papers & Methodologies

Extract key findings, datasets, and comparative methods across publications.

Benchmark Rankings & Visual Analytics

Rank top research institutions, authors, funders, topics, and journals by Field-Weighted Citation Impact (FWCI) and paper volume with instant charts.

Connect Distant Disciplines

Bridge topological clusters on the map to find hidden collaborative intersections.