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

Huabo Biopharm

Status and phase: Completed; Phase 2

Conditions: Plaque Psoriasis

Treatments: Other: Placebo; Drug: HB0017

Study type: Interventional

Funder types: Industry

Identifiers

NCT05531682

HB0017-05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 participants in 4 patient groups, including a placebo group

Experimental: HB0017 dosing regimen 1

Experimental group

Description:

HB0017 low dose short intervals of subcutaneous injection

Treatment:

Drug: HB0017

Experimental: HB0017 dosing regimen 2

Experimental group

Description:

HB0017 low dose long intervals of subcutaneous injection

Treatment:

Drug: HB0017

Experimental: HB0017 dosing regimen 3

Experimental group

Description:

HB0017 high dose long intervals of subcutaneous injection

Treatment:

Drug: HB0017

Placebo Comparator: placebo group

Placebo Comparator group

Description:

Placebo was subcutaneously injected into the 12 weeks turnover HB0017 subcutaneous injection

Treatment:

Other: Placebo