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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Plaque Psoriasis

Intervention / Treatment
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* Drug: HB0017
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects who achieve Psoriasis Area and Severity Index (PASI) 90 response or higher at week 12 |  | Week 12 | 
| Proportion of subjects who achieve static Physician Global Assessment (sPGA) 0 or 1 at week 12 |  | Week 12 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HB0017, Chronic Plaque Psoriasis