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NCT Number: NCT05531682

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

This is a randomized, double-blind, placebo-controlled, multi-center Phase 2 study to evaluate the efficacy and safety of HB0017 in subjects with moderate to severe plaque psoriasis.

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Key information

Conditions

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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About this study

This is a randomized, double-blind, placebo-controlled, multi-center Phase 2 study to evaluate the efficacy and safety of HB0017 in subjects with moderate to severe plaque psoriasis. The study will consist of 3 periods: up to 5 weeks screening period, 28 weeks treatment period, 8 weeks Safety Follow-Up period.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject has provided informed consent
  • Diagnosis of chronic plaque psoriasis with or without psoriatic arthritis for at least 6 months prior to Screening
  • Psoriasis Area and Severity Index(PASI)>=12 and body surface area(BSA) >=10% and static Physician's Global Assessment (sPGA) score 3 or greater on a 5-point scale
  • Candidates for systemic psoriasis therapy and/or phototherapy and/or chemo phototherapy
  • Women who are at childbearing age(not pregnant or breast-feeding), and subjects and their partners voluntarily use contraceptive methods deemed effective by the investigator during treatment and for at least 6 months after the last study medication

Key Exclusion Criteria:

  • Forms of psoriasis other than chronic plaque psoriasis.
  • History or evidence of active tuberculosis, Patients with evidence of latent tuberculosis may enter the trial after sufficient treatment according to protocol.
  • Positive results of confirmatory serology test for hepatitis B, hepatitis C, HIV or syphilis at screening.
  • History of a serious or systemic infection within 4 weeks before screening.
  • History of malignancy of any organ system within the past 5 years.
  • Inadequate washout period for prior drug therapy.
  • Previous use of secukinumab, ixekizumab or any other drug that targets Interleukin 17( IL-17) or IL-17 receptor.
  • Any medical conditions, in the opinion of the Investigator or the Sponsor's medical monitor, would place the subject at risk, interfere with study participation or study results interpretation.

Treatment and study plan

Placebo

Other

Subjects will receive several injections of Placebo

HB0017

Drug

Subjects will receive HB0017 in different dosing regimens

Other names: HB0017 dosing regimens

Primary outcomes

  1. PASI 90 response

    Time frame: Week 12

    Proportion of subjects who achieve Psoriasis Area and Severity Index (PASI) 90 response or higher at week 12

  2. sPGA 0/1 response

    Time frame: Week 12

    Proportion of subjects who achieve static Physician Global Assessment (sPGA) 0 or 1

Secondary outcomes

  1. PASI 75 response

    Time frame: Week 12

    Proportion of subjects who achieve PASI 75 response or higher

  2. Adverse events

    Time frame: From baseline through 36 weeks

    Treatment Related Adverse events (TEAEs)/serious adverse events (SAEs)

  3. Immunity

    Time frame: From baseline through 36 weeks

    Number and proportion of subjects who developed anti-drug antibodies (ADAs) Following Study Treatment

  4. PK characteristics

    Time frame: From Baseline through 36 weeks

    Population pharmacokinetics (PK), Apparent Total Clearance (CL/F), Apparent Volume of Distribution (V/F) of HB0017

  5. PASI responses up to 36 Weeks

    Time frame: From Baseline through 36 weeks

    Proportion of subjects who achieve PASI 50, PASI 75, PASI 90 , PASI 100 response up to 36 weeks

  6. sPGA 0/1 up to 36 Weeks

    Time frame: From Baseline through 36 weeks

    Proportion of subjects who achieve

  7. PD characterestics

    Time frame: From Baseline through 36 weeks

    HB0017 concentrations in serum at different time points

  8. PASI score change

    Time frame: From Baseline through 36 weeks

    change in PASI From Baseline to Week 36

  9. Percent change in PASI

    Time frame: From Baseline through 36 weeks

    Percent change in PASI From Baseline to Week 36

Sponsors and collaborators

Lead sponsor

Huabo Biopharm Co., Ltd.

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Efficacy and Safety of Different Dosing Regimens of HB0017 Injection in Patients With Moderate to Severe Plaque Psoriasis

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Sep 8, 2022
Registry last updated
Jun 21, 2024

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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