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
Sites (21)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University People's Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Peking University Third Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The First Affiliated Hospital of Bengbu Medical College Coordinator of this site? Confirm its status | Bengbu | China | Unknown status |
| Xiangya Hospital of Central South University Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| The Second Xiangya Hospital of Central South University Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| The Third Xiangya Hospital of Central South University Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Guangdong Provincial People's Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Dermatology Hospital of Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| The Third People's Hospital of Hangzhou Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| The First Affiliated Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| The Second Hospital of Anhui Medical University Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
| The First Affiliated Hospital of Anhui Medical University Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
| Shandong Provincial Hospital Affiliated to Shandong First Medical University Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Skin Disease Hospital of Shandong First Medical University Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Dermatology Hospital of Jiangxi Province Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| Shanghai Skin Disease Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| The First Hospital of Hebei Medical University Coordinator of this site? Confirm its status | Shijiazhuang | China | Unknown status |
| The First Affiliated Hospital of Wannan Medical College Coordinator of this site? Confirm its status | Wuhu | China | Unknown status |
| Yantai Yuhuangding Hospital Coordinator of this site? Confirm its status | Yantai | China | Unknown status |
| Affiliated Hospital of Jiangsu University Coordinator of this site? Confirm its status | Zhenjiang | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.