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NCT05531682CompletedPhase 2

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

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

Source: ClinicalTrials.gov · Last updated 21 Jun 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
160 (actual)
First submitted
31 Aug 2022
Start date
25 Oct 2022
Primary completion date
23 May 2023
Lead sponsor
Huabo Biopharm Co., Ltd.
Diseases
Psoriasis
NCT number
NCT05531682

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 160
  • From 25 Oct 2022 to the primary completion date, 23 May 2023
  • 21 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • History of a serious or systemic infection within 4 weeks before screening.
  • 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.

Other illness

  • 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 malignancy of any organ system within the past 5 years.
  • 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.

Other

  • Forms of psoriasis other than chronic plaque psoriasis.

Who the study is looking for

  • 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

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (21)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Peking University People's Hospital
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BeijingChinaUnknown status
Peking University Third Hospital
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BeijingChinaUnknown status
The First Affiliated Hospital of Bengbu Medical College
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BengbuChinaUnknown status
Xiangya Hospital of Central South University
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ChangshaChinaUnknown status
The Second Xiangya Hospital of Central South University
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ChangshaChinaUnknown status
The Third Xiangya Hospital of Central South University
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ChangshaChinaUnknown status
Guangdong Provincial People's Hospital
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GuangzhouChinaUnknown status
Dermatology Hospital of Southern Medical University
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GuangzhouChinaUnknown status
Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
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HangzhouChinaUnknown status
The Third People's Hospital of Hangzhou
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HangzhouChinaUnknown status
The First Affiliated Hospital Zhejiang University School of Medicine
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HangzhouChinaUnknown status
The Second Hospital of Anhui Medical University
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HefeiChinaUnknown status
The First Affiliated Hospital of Anhui Medical University
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HefeiChinaUnknown status
Shandong Provincial Hospital Affiliated to Shandong First Medical University
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JinanChinaUnknown status
Skin Disease Hospital of Shandong First Medical University
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JinanChinaUnknown status
Dermatology Hospital of Jiangxi Province
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NanchangChinaUnknown status
Shanghai Skin Disease Hospital
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ShanghaiChinaUnknown status
The First Hospital of Hebei Medical University
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ShijiazhuangChinaUnknown status
The First Affiliated Hospital of Wannan Medical College
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WuhuChinaUnknown status
Yantai Yuhuangding Hospital
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YantaiChinaUnknown status
Affiliated Hospital of Jiangsu University
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ZhenjiangChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.