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

Huabo Biopharm

Status and phase: Enrolling; Phase 3

Conditions: Psoriasis

Treatments: Biological: HB0017 Q8W; Biological: placebo; Biological: HB0017 Q4W

Study type: Interventional

Funder types: Industry

Identifiers

NCT06477237

HB0017-07

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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400 participants in 2 patient groups, including a placebo group

HB0017

Experimental group

Description:

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.

Treatment:

Biological: HB0017 Q4W

Biological: HB0017 Q8W

placebo

Placebo Comparator group

Description:

Participants will receive placebo at week 0,1,2,4,8 followed by HB0017 once every four weeks (Q4W) at Week 12.

Treatment:

Biological: placebo