Study of Efficacy and Safety of HB0017 in Patients With Moderate to Severe Plaque Psoriasis
NCT Number: NCT06477237
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Psoriasis
Interventions: BIOLOGICAL: HB0017 Q4W|BIOLOGICAL: HB0017 Q8W|BIOLOGICAL: placebo
Sponsor: Huabo Biopharm Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 400
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-03-01
Completion Date: 2025-12
Locations: Jiangmen Central Hospital, Jiangmen, Guangdong, China|Nanyang First People's Hospital, Nanyang, Henan, China|Beijing Friendship Hospital, Beijing, China|China-Japan Friendship hospital, Beijing, China|Peking University People's Hospital, Beijing, China|The First Affiliated Hospital of Bengbu Medical College, Bengbu, China|Jilin University Second Hospital, Chang chun, China|The first hospital of Jilin University, Chang chun, China|Xiangya Hospital of Central South University, Changsha, China|Affiliated Hospital of Chengde Medical University, Chengde, China|Sichuan Provincial People's Hospital, Chengdu, China|West China Hospital of Sichuan University, Chengdu, China|Chongqing Traditional Chinese Medicine Hospital, Chongqing, China|Dongguan People's Hospital, Dongguan, China|The First Affiliated Hospital of Fujian Medical University, Fuzhou, China|Dermatology Hospital of Southern Medical University, Guangzhou, China|Guangdong Provincial People's Hospital, Guangzhou, China|Hangzhou First People's Hospital, Hangzhou, China|Hangzhou Third People's Hospital, Hangzhou, China|The First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China|The Second Affiliated Hospital of Harbin Medical University, Harbin, China|The Second Affiliated Hospital of Anhui Medical University, Hefei, China|Jiaxing First Hospital, Jiaxing, China|Shandong Dermatology Hospital, Jinan, China|Jining First People's Hospital, Jining, China|The First Affiliated Hospital of Kunming Medical University, Kunming, China|The Second Affiliated Hospital of Kunming Medical University, Kunming, China|The Second Affiliated Hospital of Henan University of Science and Technology, Luoyang, China|Dermatology Hospital of Jiangxi Province, Nanchang, China|The Second Affiliated Hospital of Nanchang University, Nanchang, China|Jiangsu University Affiliated Hospital, Nanjing, China|Ningbo Second Hospital, Ningbo, China|Shanghai Dermatology Hospital, Shanghai, China|People's Hospital of Liaoning Province, Shenyang, China|Shenzhen People's Hospital, Shenzhen, China|Shiyan People's Hospital, Shiyan, China|The Second Hospital of Shanxi Medical University, Taiyuan, China|Wenzhou Medical University Affiliated First Hospital, Wenzhou, China|Wuhan University People's Hospital, Wuhan, China|The First Affiliated Hospital of Wannan Medical College, Wuhu, China|Wuxi Second People's Hospital, Wuxi, China|The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China|Xingtai People's Hospital, Xingtai, China|Yangjiang People's Hospital, Yangjiang, China

Summary:
This is a multicenter, randomized, double-blind, placebo-controlled, phase III clinical study which is designed to determine the efficacy, safety, immunogenicity and pharmacokinetics, and pharmacodynamics of HB0017 Injection in the treatment of moderate to severe plaque psoriasis in adults.

Primary Outcome Measures: Proportion of subjects achieving PASI 75 response at Week 12, The PASI75 response assessments are based on at least 75% improvement in PASI score from Baseline., Week 12|Proportion of subjects achieving sPGA 0/1 response at Week 12, The sPGA is a physician's determination of the participant's psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis is assessed as clear (0), Almost clear (1), mild (2), moderate (3), severe (4). An sPGA 0/1 response was defined as a post-baseline sPGA score of 0 or 1., Week 12
Secondary Outcome Measures: Proportion of subjects achieving PASI 90 response at Week 12, The PASI90 response assessments are based on at least 90% improvement in PASI score from Baseline., Week 12|PASI 90 response maintainance at week 52, Proportion of subjects maintaining PASI 90 response at Week 52 among those with PASI 90 response at Week 12, Week12-52|sPGA 0/1 response maintainance at week 52, Proportion of subjects maintaining sPGA 0/1 response at Week 52 among those with sPGA 0/1 response at Week 12., Week 12-52|PASI 75 response maintainance at week 52, Proportion of subjects maintaining PASI 75 response at Week 52 among those with PASI 75 response at Week 12., Week12-52