Clinical trial NCT05531682: A Study to Evaluate the Efficacy and Safety of HB0017 in Patients With Moderate to Severe Plaque Psoriasis
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Plaque Psoriasis
Keywords: HB0017
Chronic Plaque Psoriasis
Lead sponsor: Huabo Biopharm Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-09-08
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: PASI 90 response
timeFrame: Week 12
measure: sPGA 0/1 response
timeFrame: Week 12
Secondary outcomes:
measure: PASI 75 response
timeFrame: Week 12
measure: Adverse events
timeFrame: From baseline through 36 weeks
measure: Immunity
timeFrame: From baseline through 36 weeks
measure: PK characteristics
timeFrame: From Baseline through 36 weeks
measure: PASI responses up to 36 Weeks
timeFrame: From Baseline through 36 weeks
measure: sPGA 0/1 up to 36 Weeks
timeFrame: From Baseline through 36 weeks
measure: PD characterestics
timeFrame: From Baseline through 36 weeks
measure: PASI score change
timeFrame: From Baseline through 36 weeks
measure: Percent change in PASI
timeFrame: From Baseline through 36 weeks
Other outcomes:
Locations:
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical College
state: Anhui
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
state: Anhui
city: Hefei
country: China
facility: The Second Hospital of Anhui Medical University
state: Anhui
city: Wuhu
country: China
facility: The First Affiliated Hospital of Wannan Medical College
state: Anhui
city: Guangzhou
country: China
facility: Dermatology Hospital of Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Shijiazhuang
country: China
facility: The first hospital of Hebei Medical University
state: Hebei
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
state: Hunan
city: Zhenjiang
country: China
facility: Affiliated Hospital of Jiangsu University
state: Jiangsu
city: Nanchang
country: China
facility: Dermatology Hospital of Jiangxi Province
state: Jiangxi
city: Jinan
country: China
facility: Shandong Provincial Hospital Affiliated to Shandong First Medical University
state: Shandong
city: Jinan
country: China
facility: Skin Disease Hospital of Shandong First Medical University
state: Shandong
city: Yantai
country: China
facility: Yantai Yuhuangding hospital
state: Shandong
city: Hangzhou
country: China
facility: Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: The Third People's Hospital of Hangzhou
state: Zhejiang
city: Beijing
country: China
facility: Peking University People's Hospital
city: Beijing
country: China
facility: Peking University Third Hospital
city: Shanghai
country: China
facility: Shanghai Skin Disease Hospital
Study officials:
affiliation: Peking University People's Hospital
name: Jianzhong zhang
role: PRINCIPAL_INVESTIGATOR
References: