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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05531682
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Huabo Biopharm Co., Ltd.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jianzhong zhang
Principal Investigator Affiliation Peking University People's Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Not yet recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Plaque Psoriasis
Additional Details

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.

Arms & Interventions

Arms

Experimental: Experimental: HB0017 dosing regimen 1

HB0017 low dose short intervals of subcutaneous injection

Experimental: Experimental: HB0017 dosing regimen 2

HB0017 low dose long intervals of subcutaneous injection

Experimental: Experimental: HB0017 dosing regimen 3

HB0017 high dose long intervals of subcutaneous injection

Placebo Comparator: Placebo Comparator: placebo group

Placebo was subcutaneously injected into the 12 weeks turnover HB0017 subcutaneous injection

Interventions

Drug: - HB0017

HB0017 in different dosing regimens

Other: - Placebo

Subjects will receive several injections of Placebo

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Bengbu, Anhui, China

Status

Address

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui,

Site Contact

Congjun Jiang

fessor5195@163.com

010-88326666

Hefei, Anhui, China

Status

Address

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui,

Hefei, Anhui, China

Status

Address

The Second Hospital of Anhui Medical University

Hefei, Anhui,

Site Contact

Chunjun Yang, Dr.

yangchunjun9@163.com

010-88326666

Wuhu, Anhui, China

Status

Address

The First Affiliated Hospital of Wannan Medical College

Wuhu, Anhui,

Guangzhou, Guangdong, China

Status

Address

Dermatology Hospital of Southern Medical University

Guangzhou, Guangdong,

Site Contact

Guangming Han, Dr.

ghan54321@163.com

010-88326666

Guangdong Provincial People's Hospital, Guangzhou, Guangdong, China

Status

Address

Guangdong Provincial People's Hospital

Guangzhou, Guangdong,

Site Contact

Jianji Wan

wanjianji@aliyun.com

010-88326666

Shijiazhuang, Hebei, China

Status

Address

The first hospital of Hebei Medical University

Shijiazhuang, Hebei,

Site Contact

Guoqiang Zhang, Dr.

zgq810328@sina.com

010-88326666

Changsha, Hunan, China

Status

Address

The Second Xiangya Hospital of Central South University

Changsha, Hunan,

Site Contact

Rong Xiao, Dr.

xiaorong65@aliyun.com

010-88326666

Changsha, Hunan, China

Status

Address

The Third Xiangya Hospital of Central South University

Changsha, Hunan,

Site Contact

Jianyun Lu, Dr.

1010739024@qq.com

010-88326666

Changsha, Hunan, China

Status

Address

Xiangya Hospital of Central South University

Changsha, Hunan,

Site Contact

Juan Su, Dr.

540020068@qq.com

010-88326666

Zhenjiang, Jiangsu, China

Status

Address

Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu,

Site Contact

Yumei Li, Dr.

l.yumei@aliyun.com

010-88326666

Dermatology Hospital of Jiangxi Province, Nanchang, Jiangxi, China

Status

Address

Dermatology Hospital of Jiangxi Province

Nanchang, Jiangxi,

Site Contact

Fengming Hu

1262200957@qq.com

010-88326666

Jinan, Shandong, China

Status

Address

Shandong Provincial Hospital Affiliated to Shandong First Medical University

Jinan, Shandong,

Jinan, Shandong, China

Status

Address

Skin Disease Hospital of Shandong First Medical University

Jinan, Shandong,

Site Contact

Furen Zhang, Dr.

zhangfuren@hotmail.com

010-88326666

Yantai Yuhuangding hospital, Yantai, Shandong, China

Status

Address

Yantai Yuhuangding hospital

Yantai, Shandong,

Hangzhou, Zhejiang, China

Status

Address

Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang,

Site Contact

Liming Wu, Dr.

18957118053@163.com

010-88326666

Hangzhou, Zhejiang, China

Status

Address

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang,

Site Contact

Jiangjun Qiao, Dr.

qiaojianjun@126.com

010-88326666

The Third People's Hospital of Hangzhou, Hangzhou, Zhejiang, China

Status

Address

The Third People's Hospital of Hangzhou

Hangzhou, Zhejiang,

Peking University People's Hospital, Beijing, China

Status

Address

Peking University People's Hospital

Beijing, ,

Site Contact

Jianzhong Zhang

rmzjz@126.com

010-88326666

Peking University Third Hospital, Beijing, China

Status

Address

Peking University Third Hospital

Beijing, ,

Site Contact

Chunlei Zhang, Dr.

zhangchunleius@163.com

010-88326666

Shanghai Skin Disease Hospital, Shanghai, China

Status

Address

Shanghai Skin Disease Hospital

Shanghai, ,

Site Contact

Yangfeng Ding

dingyangfeng@aliyun.com

010-88326666

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