Evidence map›Paper›PMID 40517362›Full record

ArticleDermatology and therapy2025

Investigation of the Efficacy and Safety of Xeligekimab (GR1501) in Patients with Moderate-to-Severe Plaque Psoriasis: A Multicenter, Randomized, Double-Blind Phase II Clinical trial.

Lin Cai, Chengxin Li, Shanshan Li, Xiaodong Zhang, Gang Wang, Jianbin Yu, Kun Huang, Hong Fang, Yangfeng Ding, Jinyan Wang and 4 more

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Article in Dermatology and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors.

Lin CaiDepartment of Dermatology, Peking University People's Hospital, No. 11 Xizhimen South Street, Xicheng District, Beijing, 100044, China.
Chengxin LiDepartment of Dermatology, Chinese PLA General Hospital, Beijing, China.
Shanshan LiDepartment of Dermatology, The First Hospital of Jilin University, Changchun, China.
Xiaodong ZhangGeneral Hospital of Northern Theater Command, Chinese PLA, Shenyang, China.
Gang WangThe First Affiliated Hospital of Air Force Medical University, Xi'an, China.
Jianbin YuDepartment of Dermatology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China.
Kun HuangThe First Affiliated Hospital of Chongqing Medical University, Chongqing, China.
Hong FangThe First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.
Yangfeng DingShanghai Skin Disease Hospital, Shanghai, China.
Jinyan WangDepartment of Dermatology, Ningbo Second Hospital, Ningbo, Zhejiang, China.
Congjun JiangDepartment of Dermatology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China.
Qianjin LuInstitute of Dermatology, Chinese Academy of Medical Sciences, Nanjing, Jiangsu, China.
Juan TaoDepartment of Dermatology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.
Jianzhong ZhangDepartment of Dermatology, Peking University People's Hospital, No. 11 Xizhimen South Street, Xicheng District, Beijing, 100044, China. rmzjz@126.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPsoriasis is a chronic inflammatory skin disease. This study evaluated the efficacy and safety of xeligekimab (GR1501), a novel anti-interleukin-17A (anti-IL-17A) monoclonal antibody, in Chinese patients with moderate-to-severe plaque psoriasis.

methodsIn this multicenter, randomized, double-blind, phase II trial, 199 patients were assigned (1:1:1:1) to receive placebo (n = 49) or xeligekimab 100 mg (n = 50), 150 mg (n = 49), or 200 mg (n = 51) every 4 weeks for 12 weeks. All participants then entered a 40-week extension receiving xeligekimab 200 mg every 4 or 8 weeks. The primary endpoint was a 75% reduction in the Psoriasis Area and Severity Index (PASI 75) at week 12. Secondary endpoints included PASI 75, PASI 90 (≥ 90% improvement), and a static Physician's Global Assessment (sPGA) score of 0/1 (clear/almost clear) at week 52. Safety, pharmacokinetics (PK), and anti-drug antibodies (ADA) were also assessed.

resultsAt week 12, PASI 75 response rates for the 100, 150, and 200 mg groups were 86.0%, 89.8%, and 88.2%, respectively, versus 2.0% for placebo (P < 0.05). At week 52, PASI 75, PASI 90, and sPGA 0/1 response rates remained high in both 4-week (98.8%, 83.3%, 77.4%) and 8-week (92.9%, 83.3%, 78.6%) groups. No dose-dependent safety issues or ADA positivity were observed.

conclusionXeligekimab demonstrated strong efficacy, sustained response, and favorable safety in patients with moderate-to-severe plaque psoriasis. TRIAL REGISTRATION NUMBER: ChiCTR1800017956.

Indexed as

Drug-related side effects and adverse reactionsImmunityPsoriasisRandomized controlled trialsXeligekimab

Identifiers

PMID40517362
PMCPMC12454832

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.