Study of Efficacy and Safety of HB0017 in Patients With Moderate to Severe Plaque Psoriasis
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of HB0017 Injection in Patients With Moderate to Severe Plaque Psoriasis
1 other identifier
interventional
400
1 country
44
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2024
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2024
CompletedFirst Submitted
Initial submission to the registry
June 18, 2024
CompletedFirst Posted
Study publicly available on registry
June 27, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedJune 27, 2024
June 1, 2024
5 months
June 18, 2024
June 25, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
Proportion of subjects achieving PASI 90 response at Week 12
Week 12
PASI 90 response maintainance at week 52
Week12-52
sPGA 0/1 response maintainance at week 52
Week 12-52
PASI 75 response maintainance at week 52
Week12-52
Study Arms (2)
HB0017
EXPERIMENTALParticipants will receive HB0017 at week 0,1,2,4,8 followed by once every four weeks (Q4W) or once every eight weeks (Q8W) at Week 12.
placebo
PLACEBO COMPARATORParticipants will receive placebo at week 0,1,2,4,8 followed by HB0017 once every four weeks (Q4W) at Week 12.
Interventions
Eligibility Criteria
You may qualify if:
- Male or female subjects aged 18-75 years (inclusive)
- Chronic plaque psoriasis (PSO) for at least 6 months prior to the Randomization.
- Psoriasis Area Severity Index (PASI) \>=12 and body surface area (BSA) affected by PSO \>=10% and Static Physician Global Assessment (sPGA) score \>=3.
- Subjects who are suitable for systemic treatment or phototherapy for psoriasis as judged by the investigator
- Subjects who are able to use effective contraception from the screening period to 6 months after the last dose
You may not qualify if:
- Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and/or guttate psoriasis) at screening or baseline
- Drug-induced psoriasis
- Ongoing use of prohibited treatments
- Any active infection (other than common cold) within 14 days
- Serious infection defined as requiring hospitalization or iv anti-infective(s) within 1 month prior to randomization
- Have previously received any drug that directly targets IL-17 or IL-17 receptor
- Have concurrent or recent use of any biologic agent within the following washout periods: etanercept \<28 days; infliximab and adalimumab \<60 days; golimumab \< 90 days; anti-IL-12/anti-IL-23 or anti-IL-23p19 antibody drugs \<6 months; or other anti-psoriatic therapy not listed herein within its 5 half-lives prior to randomization
- A history of inflammatory bowel disease or other serious autoimmune disease
- Previously diagnosed with serious mental illness such as anxiety, depression or suicidal tendency
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (44)
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
Changchun, China
The first hospital of Jilin University
Changchun, 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jianzhong Zhang, MD
Peking University People's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2024
First Posted
June 27, 2024
Study Start
March 1, 2024
Primary Completion
August 1, 2024
Study Completion
December 1, 2025
Last Updated
June 27, 2024
Record last verified: 2024-06