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

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.

Study Overview

• Status: Completed
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Other: Placebo; Drug: HB0017

Detailed Description

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. The study will consist of 3 periods: up to 5 weeks screening period, 28 weeks treatment period, 8 weeks Safety Follow-Up period.

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking University Third Hospital
  • Beijing, China
    • Peking University People's Hospital
  • Shanghai, China
    • Shanghai Skin Disease Hospital
  • Anhui
    • Bengbu, Anhui, China
      • The First Affiliated Hospital of Bengbu Medical College
    • Hefei, Anhui, China
      • The First Affiliated Hospital of Anhui Medical University
    • Hefei, Anhui, China
      • The Second Hospital of Anhui Medical University
    • Wuhu, Anhui, China
      • The First Affiliated Hospital of Wannan Medical College
  • Guangdong
    • Guangzhou, Guangdong, China
      • Dermatology Hospital of Southern Medical University
    • Guangzhou, Guangdong, China
      • Guangdong Provincial People's Hospital
  • Hebei
    • Shijiazhuang, Hebei, China
      • The First Hospital of Hebei Medical University
  • Hunan
    • Changsha, Hunan, 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
  • Jiangsu
    • Zhenjiang, Jiangsu, China
      • Affiliated Hospital of Jiangsu University
  • Jiangxi
    • Nanchang, Jiangxi, China
      • Dermatology Hospital of Jiangxi Province
  • Shandong
    • Jinan, Shandong, China
      • Shandong Provincial Hospital Affiliated to Shandong First Medical University
    • Jinan, Shandong, China
      • Skin Disease Hospital of Shandong First Medical University
    • Yantai, Shandong, China
      • Yantai Yuhuangding Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • The First Affiliated Hospital, Zhejiang University School of Medicine
    • Hangzhou, Zhejiang, China
      • Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
    • Hangzhou, Zhejiang, China
      • The Third People's Hospital of Hangzhou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Key Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: HB0017 dosing regimen 1; HB0017 low dose short intervals of subcutaneous injection	Drug: HB0017; Subjects will receive HB0017 in different dosing regimens; Other Names: HB0017 dosing regimens
Experimental: Experimental: HB0017 dosing regimen 2; HB0017 low dose long intervals of subcutaneous injection	Drug: HB0017; Subjects will receive HB0017 in different dosing regimens; Other Names: HB0017 dosing regimens
Experimental: Experimental: HB0017 dosing regimen 3; HB0017 high dose long intervals of subcutaneous injection	Drug: HB0017; Subjects will receive HB0017 in different dosing regimens; Other Names: HB0017 dosing regimens
Placebo Comparator: Placebo Comparator: placebo group; Placebo was subcutaneously injected into the 12 weeks turnover HB0017 subcutaneous injection	Other: Placebo; Subjects will receive several injections of Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
PASI 75 response	Proportion of subjects who achieve PASI 75 response or higher	Week 12
Adverse events	Treatment Related Adverse events (TEAEs)/serious adverse events (SAEs)	From baseline through 36 weeks
Immunity	Number and proportion of subjects who developed anti-drug antibodies (ADAs) Following Study Treatment	From baseline through 36 weeks
PK characteristics	Population pharmacokinetics (PK), Apparent Total Clearance (CL/F)， Apparent Volume of Distribution (V/F) of HB0017	From Baseline through 36 weeks
PASI responses up to 36 Weeks	Proportion of subjects who achieve PASI 50, PASI 75, PASI 90 , PASI 100 response up to 36 weeks	From Baseline through 36 weeks
sPGA 0/1 up to 36 Weeks	Proportion of subjects who achieve	From Baseline through 36 weeks
PD characterestics	HB0017 concentrations in serum at different time points	From Baseline through 36 weeks
PASI score change	change in PASI From Baseline to Week 36	From Baseline through 36 weeks
Percent change in PASI	Percent change in PASI From Baseline to Week 36	From Baseline through 36 weeks

Collaborators and Investigators

• Sponsor: Huabo Biopharm Co., Ltd.
• Investigators: Principal Investigator: Jianzhong Zhang, Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2022
• Primary Completion (Actual): May 23, 2023
• Study Completion (Actual): January 4, 2024

Study Registration Dates

• First Submitted: August 31, 2022
• First Submitted That Met QC Criteria: September 6, 2022
• First Posted (Actual): September 8, 2022

Study Record Updates

• Last Update Posted (Actual): June 21, 2024
• Last Update Submitted That Met QC Criteria: June 18, 2024
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Chronic Plaque Psoriasis; HB0017
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: HB0017-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No