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

Phase 3

Recruiting

• Conditions: Psoriasis

• Registration Number: NCT06477237
• Lead Sponsor: Huabo Biopharm Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-01
• Status Verified: 2024-06
• Study First Submitted: 2024-06-18
• Study First Submitted QC: 2024-06-25
• Last Update Submitted: 2024-06-25
• Study First Posted: 2024-06-27
• Last Update Posted: 2024-06-27
• Primary Completion: 2024-08
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Proportion of subjects achieving PASI 75 response at Week 12	Week 12	The PASI75 response assessments are based on at least 75% improvement in PASI score from Baseline.
Proportion of subjects achieving sPGA 0/1 response at Week 12	Week 12	The sPGA is a physician's determination of the participant's psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis is assessed as clear (0), Almost clear (1), mild (2), moderate (3), severe (4). An sPGA 0/1 response was defined as a post-baseline sPGA score of 0 or 1.

Secondary Outcome Measures

Name	Time	Method
PASI 90 response maintainance at week 52	Week12-52	Proportion of subjects maintaining PASI 90 response at Week 52 among those with PASI 90 response at Week 12
Proportion of subjects achieving PASI 90 response at Week 12	Week 12	The PASI90 response assessments are based on at least 90% improvement in PASI score from Baseline.
PASI 75 response maintainance at week 52	Week12-52	Proportion of subjects maintaining PASI 75 response at Week 52 among those with PASI 75 response at Week 12.
sPGA 0/1 response maintainance at week 52	Week 12-52	Proportion of subjects maintaining sPGA 0/1 response at Week 52 among those with sPGA 0/1 response at Week 12.

Trial Locations

Locations (44)

Jiangmen Central Hospital; 🇨🇳 Jiangmen, Guangdong, China

Nanyang First People's Hospital; 🇨🇳 Nanyang, Henan, China

Beijing Friendship Hospital; 🇨🇳 Beijing, China

China-Japan Friendship hospital; 🇨🇳 Beijing, China

Peking University People's Hospital; 🇨🇳 Beijing, China

The First Affiliated Hospital of Bengbu Medical College; 🇨🇳 Bengbu, China

Jilin University Second Hospital; 🇨🇳 Chang chun, China

The first hospital of Jilin University; 🇨🇳 Chang chun, China

Xiangya Hospital of Central South University; 🇨🇳 Changsha, China

Affiliated Hospital of Chengde Medical University; 🇨🇳 Chengde, China

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