Study of Efficacy and Safety of HB0017 in Patients With Moderate to Severe Plaque Psoriasis

June 25, 2024 updated by: Huabo Biopharm Co., Ltd.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jianzhong Zhang, MD
  • Phone Number: 86-10-88326666
  • Email: rmzjz@126.com

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Peking University People's Hospital
        • Contact:
          • Jianzhong Zhang, MD
          • Phone Number: +861088326666
          • Email: rmzjz@126.com
        • Principal Investigator:
          • Cheng Zhou, MD
        • Principal Investigator:
          • Jianzhong Zhang, MD
      • Beijing, China
        • Recruiting
        • Beijing Friendship Hospital
        • Contact:
      • Beijing, China
        • Recruiting
        • China-Japan Friendship Hospital
        • Contact:
      • Bengbu, China
        • Recruiting
        • The First Affiliated Hospital of Bengbu Medical College
        • Contact:
      • Chang chun, China
        • Recruiting
        • Jilin University Second Hospital
        • Contact:
      • Chang chun, China
        • Recruiting
        • The First Hospital of Jilin University
        • Contact:
      • Changsha, China
        • Recruiting
        • Xiangya Hospital of Central South University
        • Contact:
      • Chengde, China
        • Recruiting
        • Affiliated Hospital of Chengde Medical University
        • Contact:
      • Chengdu, China
        • Not yet recruiting
        • West China Hospital of Sichuan University
        • Contact:
      • Chengdu, China
        • Not yet recruiting
        • Sichuan Provincial People's Hospital
        • Contact:
      • Chongqing, China
        • Not yet recruiting
        • Chongqing Traditional Chinese Medicine Hospital
        • Contact:
      • Dongguan, China
        • Recruiting
        • Dongguan People's Hospital
        • Contact:
      • Fuzhou, China
        • Recruiting
        • The First Affiliated Hospital of Fujian Medical University
        • Contact:
      • Guangzhou, China
        • Recruiting
        • Guangdong Provincial People's Hospital
        • Contact:
      • Guangzhou, China
        • Recruiting
        • Dermatology Hospital of Southern Medical University
        • Contact:
      • Hangzhou, China
        • Recruiting
        • Hangzhou First People's Hospital
        • Contact:
      • Hangzhou, China
        • Not yet recruiting
        • Hangzhou Third People's Hospital
        • Contact:
      • Hangzhou, China
        • Not yet recruiting
        • The First Affiliated Hospital of Zhejiang University School of Medicine
        • Contact:
      • Harbin, China
        • Recruiting
        • The Second Affiliated Hospital of Harbin Medical University
        • Contact:
      • Hefei, China
        • Recruiting
        • The Second Affiliated Hospital of Anhui Medical University
        • Contact:
      • Jiaxing, China
        • Recruiting
        • Jiaxing First Hospital
        • Contact:
      • Jinan, China
        • Recruiting
        • Shandong Dermatology Hospital
        • Contact:
      • Jining, China
        • Not yet recruiting
        • Jining First People's Hospital
        • Contact:
      • Kunming, China
        • Recruiting
        • The First Affiliated Hospital of Kunming Medical University
        • Contact:
      • Kunming, China
        • Recruiting
        • The Second Affiliated Hospital of Kunming Medical University
        • Contact:
      • Luoyang, China
        • Recruiting
        • The Second Affiliated Hospital of Henan University of Science and Technology
        • Contact:
      • Nanchang, China
        • Recruiting
        • The Second Affiliated Hospital of Nanchang University
        • Contact:
      • Nanchang, China
        • Recruiting
        • Dermatology Hospital of Jiangxi Province
        • Contact:
      • Nanjing, China
        • Recruiting
        • Jiangsu University Affiliated Hospital
        • Contact:
      • Ningbo, China
        • Recruiting
        • Ningbo Second Hospital
        • Contact:
      • Shanghai, China
        • Recruiting
        • Shanghai Dermatology Hospital
        • Contact:
      • Shenyang, China
        • Recruiting
        • People's Hospital of Liaoning Province
        • Contact:
      • Shenzhen, China
        • Recruiting
        • ShenZhen People's Hospital
        • Contact:
      • Shiyan, China
        • Recruiting
        • Shiyan People's Hospital
        • Contact:
      • Taiyuan, China
        • Recruiting
        • The Second Hospital of Shanxi Medical University
        • Contact:
      • Wenzhou, China
        • Recruiting
        • Wenzhou Medical University Affiliated First Hospital
        • Contact:
      • Wuhan, China
        • Recruiting
        • Wuhan University People's Hospital
        • Contact:
      • Wuhu, China
        • Recruiting
        • The First Affiliated Hospital of Wannan Medical College
        • Contact:
      • Wuxi, China
        • Recruiting
        • Wuxi Second People's Hospital
        • Contact:
      • Xi'an, China
        • Recruiting
        • The Second Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
      • Xingtai, China
        • Recruiting
        • Xingtai People's Hospital
        • Contact:
      • Yangjiang, China
        • Not yet recruiting
        • Yangjiang People's Hospital
        • Contact:
    • Guangdong
      • Jiangmen, Guangdong, China
        • Not yet recruiting
        • Jiangmen Central Hospital
        • Contact:
    • Henan
      • Nanyang, Henan, China
        • Recruiting
        • Nanyang First People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Key Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HB0017
Participants 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.
Biological: HB0017 Q4W
HB0017 at W0,1,2,4,8+HB0017Q4W
Biological: HB0017 Q8W
HB0017 at W0,1,2,4,8+HB0017Q8W
Placebo Comparator: placebo
Participants will receive placebo at week 0,1,2,4,8 followed by HB0017 once every four weeks (Q4W) at Week 12.
Biological: placebo
placebo at W0,1,2,4,8+HB0017Q4W

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of subjects achieving PASI 75 response at Week 12
Time Frame: 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
Time Frame: 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

Outcome Measure
Measure Description
Time Frame
Proportion of subjects achieving PASI 90 response at Week 12
Time Frame: 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
Time Frame: Week12-52
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
Time Frame: Week 12-52
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
Time Frame: Week12-52
Proportion of subjects maintaining PASI 75 response at Week 52 among those with PASI 75 response at Week 12.
Week12-52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huabo Biopharm Co., Ltd.

Investigators

  • Principal Investigator: Jianzhong Zhang, MD, Peking University People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

June 18, 2024

First Submitted That Met QC Criteria

June 25, 2024

First Posted (Actual)

June 27, 2024

Study Record Updates

Last Update Posted (Actual)

June 27, 2024

Last Update Submitted That Met QC Criteria

June 25, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HB0017-07

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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