A Study to Evaluate the Efficacy and Safety of HB0017 in Patients With Moderate to Severe Plaque Psoriasis
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Efficacy and Safety of Different Dosing Regimens of HB0017 Injection in Patients With Moderate to Severe Plaque Psoriasis
1 other identifier
interventional
160
1 country
21
Brief Summary
This is a randomized, double-blind, placebo-controlled, multi-center Phase 2 study to evaluate the efficacy and safety of HB0017 in subjects with moderate to severe plaque psoriasis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2022
Shorter than P25 for phase_2
21 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
First Submitted
Initial submission to the registry
August 31, 2022
CompletedFirst Posted
Study publicly available on registry
September 8, 2022
CompletedStudy Start
First participant enrolled
October 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 23, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 4, 2024
CompletedJune 21, 2024
September 1, 2022
7 months
August 31, 2022
June 18, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
PASI 90 response
Proportion of subjects who achieve Psoriasis Area and Severity Index (PASI) 90 response or higher at week 12
Week 12
sPGA 0/1 response
Proportion of subjects who achieve static Physician Global Assessment (sPGA) 0 or 1
Week 12
Secondary Outcomes (9)
PASI 75 response
Week 12
Adverse events
From baseline through 36 weeks
Immunity
From baseline through 36 weeks
PK characteristics
From Baseline through 36 weeks
PASI responses up to 36 Weeks
From Baseline through 36 weeks
- +4 more secondary outcomes
Study Arms (4)
Experimental: HB0017 dosing regimen 1
EXPERIMENTALHB0017 low dose short intervals of subcutaneous injection
Experimental: HB0017 dosing regimen 2
EXPERIMENTALHB0017 low dose long intervals of subcutaneous injection
Experimental: HB0017 dosing regimen 3
EXPERIMENTALHB0017 high dose long intervals of subcutaneous injection
Placebo Comparator: placebo group
PLACEBO COMPARATORPlacebo was subcutaneously injected into the 12 weeks turnover HB0017 subcutaneous injection
Interventions
Subjects will receive HB0017 in different dosing regimens
Eligibility Criteria
You may qualify if:
- Subject has provided informed consent
- Diagnosis of chronic plaque psoriasis with or without psoriatic arthritis for at least 6 months prior to Screening
- Psoriasis Area and Severity Index(PASI)\>=12 and body surface area(BSA) \>=10% and static Physician's Global Assessment (sPGA) score 3 or greater on a 5-point scale
- Candidates for systemic psoriasis therapy and/or phototherapy and/or chemo phototherapy
- Women who are at childbearing age(not pregnant or breast-feeding), and subjects and their partners voluntarily use contraceptive methods deemed effective by the investigator during treatment and for at least 6 months after the last study medication
You may not qualify if:
- Forms of psoriasis other than chronic plaque psoriasis.
- History or evidence of active tuberculosis, Patients with evidence of latent tuberculosis may enter the trial after sufficient treatment according to protocol.
- Positive results of confirmatory serology test for hepatitis B, hepatitis C, HIV or syphilis at screening.
- History of a serious or systemic infection within 4 weeks before screening.
- History of malignancy of any organ system within the past 5 years.
- Inadequate washout period for prior drug therapy.
- Previous use of secukinumab, ixekizumab or any other drug that targets Interleukin 17( IL-17) or IL-17 receptor.
- Any medical conditions, in the opinion of the Investigator or the Sponsor's medical monitor, would place the subject at risk, interfere with study participation or study results interpretation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
The first hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
Dermatology Hospital of Jiangxi Province
Nanchang, Jiangxi, China
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, China
Skin Disease Hospital of Shandong First Medical University
Jinan, Shandong, China
Yantai Yuhuangding hospital
Yantai, Shandong, China
Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The Third People's Hospital of Hangzhou
Hangzhou, Zhejiang, China
Peking University People's Hospital
Beijing, China
Peking University Third Hospital
Beijing, China
Shanghai Skin Disease Hospital
Shanghai, China
Study Officials
- PRINCIPAL INVESTIGATOR
Jianzhong zhang
Peking University People's Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- 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
August 31, 2022
First Posted
September 8, 2022
Study Start
October 25, 2022
Primary Completion
May 23, 2023
Study Completion
January 4, 2024
Last Updated
June 21, 2024
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share