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NCT Number: NCT06592274

A Phase 2 Study of HB0017 in Psoriasis Patients

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HB0017

Biological

300mg Q12W

Primary outcomes

  1. Proportion of subjects achieving PASI 90 response

    Time frame: Week 12

    The PASI75 response assessments are based on at least 90% improvement in PASI score from Baseline.

  2. Proportion of subjects achieving sPGA 0/1

    Time frame: 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 outcomes

  1. Proportion of subjects achieving PASI 75 response

    Time frame: Week 12

    The PASI75 response assessments are based on at least 75% improvement in PASI score from Baseline.

  2. Proportion of subjects achieving PASI 100 response

    Time frame: Week 12

    The PASI100 response assessments are based on 100% improvement in PASI score from Baseline

  3. PASI 90 response maintainance at week 48

    Time frame: Week12-48

    Proportion of subjects maintaining PASI 90 response at Week 48 among those with PASI 90 response at Week 12

  4. sPGA 0/1 response maintainance at week 48

    Time frame: Week12-48

    Proportion of subjects maintaining sPGA 0/1 response at Week 48 among those with sPGA 0/1 response at Week 12.

Sponsors and collaborators

Lead sponsor

Huabo Biopharm Co., Ltd.

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-blind Phase 2 Clinical Study Evaluating the Efficacy and Safety of Different Administration Regimens of HB0017 Injection in Patients With Moderate to Severe Plaque Psoriasis

Acronym: HB0017

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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