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Study of Efficacy and Safety of HB0017 in Patients With Moderate to Severe Plaque Psoriasis | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of HB0017 Injection in Patients With Moderate to Severe Plaque Psoriasis

NCT06477237•Huabo Biopharm Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

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

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

Changchun, China

The first hospital of Jilin University

Changchun, China

Xiangya Hospital of Central South University

Changsha, China

Affiliated Hospital of Chengde Medical University

Chengde, China

Key Dates

Start Date

March 1, 2024

Primary Completion Date

August 1, 2024

Completion Date

December 1, 2025

Last Updated

June 27, 2024

Enrollment

400

ESTIMATED participants

Conditions

Psoriasis

Interventions

HB0017 Q4W

BIOLOGICAL

HB0017 Q8W

BIOLOGICAL

placebo

BIOLOGICAL

Contacts

Jianzhong Zhang, MD

CONTACT

86-10-88326666 rmzjz@126.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 27, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

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A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

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