A Phase 2 Study of HB0017 in Psoriasis Patients

Huabo Biopharm

Status and phase: Enrolling; Phase 2

Conditions: Psoriasis (PsO)

Treatments: Biological: HB0017

Study type: Interventional

Funder types: Industry

Identifiers

NCT06592274

HB0017-PsO-02-02

Details and patient eligibility

About

This study is a randomized, double-blind phase 2 clinical trial aimed at exploring the efficacy, safety, and immunogenicity of HB0017 injection with different dosing regimens in the treatment of moderate to severe plaque psoriasis in subjects

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 3 patient groups

Experimental Group 1

Experimental group

Description:

HB0017 higer dose plus longer dose regimen

Treatment:

Biological: HB0017

Biological: HB0017

Biological: HB0017

Experimental Group 2

Experimental group

Description:

HB0017 higer dose plus shorter dose regimen

Treatment:

Biological: HB0017

Biological: HB0017

Biological: HB0017

Experimental Group 3

Experimental group

Description:

HB0017 low dose plus shortest dose regimen

Treatment:

Biological: HB0017

Biological: HB0017

Biological: HB0017