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Recruiting NCT06592274

A Phase 2 Study of HB0017 in Psoriasis Patients

Phase II Interventional Psoriasis (PsO)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HB0017, HB0017, HB0017.
Who it may be relevant to
Registry conditions: Psoriasis (PsO). Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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

Interventions

  • Biological HB0017
    300mg Q12W
  • Biological HB0017
    300mg Q8W
  • Biological HB0017
    150mg Q4W

Primary outcome measures

  • Proportion of subjects achieving PASI 90 response [Time frame: Week 12]
  • Proportion of subjects achieving sPGA 0/1 [Time frame: Week 12]
Secondary outcome measures (4)
  • Proportion of subjects achieving PASI 75 response [Time frame: Week 12]
  • Proportion of subjects achieving PASI 100 response [Time frame: Week 12]
  • PASI 90 response maintainance at week 48 [Time frame: Week12-48]
  • sPGA 0/1 response maintainance at week 48 [Time frame: Week12-48]

Eligibility 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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 18 centers
  • The First Affiliated Hospital of Bengbu Medical College — Bengbu
  • Southern Medical University Dermatology Hospital — Guangzhou
  • Xiangya Hospital of Central South University — Changsha
  • Wuxi Second People's Hospital — Wuxi
  • Jiangsu University Affiliated Hospital — Zhenjiang
  • Jilin University Second Hospital — Changchun
  • Shandong First Medical University Affiliated Dermatology Hospital — Jinan
  • Jining First People's Hospital — Jining
  • … and 10 more centers

Identifiers

NCT: NCT06592274 · HB0017-PsO-02-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗