Randomised, double-blind, multicentre, phase Ⅰ/Ⅱ dose escalation and expansion trial of GR1501 in patients with plaque psoriasis: study protocol
Qi Wang,
Lin Cai,
Qian Wang,
Wenliang Dong,
Xiaoyan Nie,
Jiaxue Wang,
Lin Xia,
Weixing Fu,
Tiantian Shen,
Huaying Fan,
Suping Niu,
Yimin Cui,
Qingshan Zheng,
Jianzhong Zhang,
Yi Fang
Affiliations
Qi Wang
College of Public Administration and Humanities, Dalian Maritime University, Dalian, China
Lin Cai
Department of Neurosurgery, Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University, Shanghai, China
Qian Wang
3 Department of Rheumatology and Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China
Wenliang Dong
Department of Pharmacy, Peking University People`s Hospital, Beijing, China
Xiaoyan Nie
Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmaceutical Sciences, Peking University, Beijing, China
Jiaxue Wang
Department of Pharmacy, Peking University People`s Hospital, Beijing, China
Lin Xia
Department of Pharmacy, Xuzhou Medical University, Xuzhou, Jiangsu, China
Weixing Fu
Genrix (Shanghai) Biopharmaceutical Co., Shanghai, China, Shanghai, China
Tiantian Shen
Department of Pharmacy, Xuzhou Medical University, Xuzhou, Jiangsu, China
Huaying Fan
Department of Science and Research, Peking University People`s Hospital, Beijing, China
Suping Niu
Department of Science and Research, Peking University People`s Hospital, Beijing, China
Yimin Cui
Department of Pharmacy, Peking University First Hospital, Beijing, China
Qingshan Zheng
Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai, Shanghai, China
Jianzhong Zhang
Department of Dermatology, Peking University People`s Hospital, Beijing, China
Yi Fang
Department of Nephrology, Zhongshan Hospital, Fudan University, Shanghai, China
Introduction Psoriasis is a life-long, immune-mediated disease that greatly reduces the quality of life of patients. Plaque psoriasis is the most common form of psoriasis. Treatment options for plaque psoriasis with good tolerance and sufficient response remain profoundly limited. Based on mechanistic findings that suggest the key pathogenic role of interleukin (IL)-17 in plaque psoriasis, we hypothesise that GR1501, a new monoclonal antibody (IL-17A targeted), will be an efficacious treatment for plaque psoriasis. This phase I/II trial aims to evaluate the safety, tolerability, pharmacokinetics, immunogenicity and preliminary efficacy of GR1501.Methods and analysis A multicentre, randomised, double-blind, phase I/II dose escalation and expansion trial will be conducted at four hospitals in China. In total, 226 patients with plaque psoriasis will be enrolled in the study, with 46 cases in the dose-escalation stage and 180 cases randomised to GR1501 or the placebo in a 3:1 ratio in the expansion cohort. The primary outcomes are safety and tolerability; the secondary outcomes include pharmacokinetics, immunogenicity and efficacy.Ethics and dissemination The study is in accordance with the Declaration of Helsinki, and the ethics approvals of the protocol have been obtained from the ethics committees of all participating centres, including Peking University People’s Hospital, Chinese PLA General Hospital, The First Affiliated Hospital, College of Medicine, Zhejiang University and the Second Xiangya Hospital of Central South University. The findings of the study will be presented in published journals or at scientific conferences or meetings.Trial registration number ChiCTR1800017956.
