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

Plaque Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05531682
• Other study ID #: HB0017-05
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: October 2022
• Est. completion date: December 2023

Study information

• Verified date: September 2022
• Source: Huabo Biopharm Co., Ltd.
• Contact: Jianzhong zhang, Dr.
• Phone: 010-88326666
• Email: rmzjz[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: December 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• HB0017
HB0017 in different dosing regimens

Other:
• Placebo
Subjects will receive several injections of Placebo

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing
China	Peking University Third Hospital	Beijing
China	The First Affiliated Hospital of Bengbu Medical College	Bengbu	Anhui
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan
China	The Third Xiangya Hospital of Central South University	Changsha	Hunan
China	Xiangya Hospital of Central South University	Changsha	Hunan
China	Dermatology Hospital of Southern Medical University	Guangzhou	Guangdong
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong
China	Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	The First Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	The Third People's Hospital of Hangzhou	Hangzhou	Zhejiang
China	The First Affiliated Hospital of Anhui Medical University	Hefei	Anhui
China	The Second Hospital of Anhui Medical University	Hefei	Anhui
China	Shandong Provincial Hospital Affiliated to Shandong First Medical University	Jinan	Shandong
China	Skin Disease Hospital of Shandong First Medical University	Jinan	Shandong
China	Dermatology Hospital of Jiangxi Province	Nanchang	Jiangxi
China	Shanghai Skin Disease Hospital	Shanghai
China	The first hospital of Hebei Medical University	Shijiazhuang	Hebei
China	The First Affiliated Hospital of Wannan Medical College	Wuhu	Anhui
China	Yantai Yuhuangding hospital	Yantai	Shandong
China	Affiliated Hospital of Jiangsu University	Zhenjiang	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Huabo Biopharm Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects who achieve Psoriasis Area and Severity Index (PASI) 90 response or higher at week 12		Week 12
Primary	Proportion of subjects who achieve static Physician Global Assessment (sPGA) 0 or 1 at week 12		Week 12
Secondary	Proportion of subjects who achieve PASI 75 response or higher at week 12		Week 12
Secondary	Treatment Related Adverse events (TEAEs)/serious adverse events (SAEs)		From baseline through 36 weeks
Secondary	Number and proportion of subjects who developed anti-drug antibodies (ADAs) Following Study Treatment		From baseline through 36 weeks
Secondary	Population pharmacokinetics (PK), Apparent Total Clearance (CL/F) of HB0017		From Baseline through 36 weeks
Secondary	Proportion of subjects who achieve PASI 50, PASI 75, PASI 90 , PASI 100 response up to 36 weeks		From Baseline through 36 weeks
Secondary	Proportion of subjects who achieve sPGA 0 or 1 up to 36 Weeks		From Baseline through 36 weeks
Secondary	HB0017 concentrations in serum at different time points		From Baseline through 36 weeks
Secondary	change in PASI From Baseline to Week 36		From Baseline through 36 weeks
Secondary	Population pharmacokinetics (PK), Apparent Volume of Distribution (V/F) of HB0017		From Baseline through 36 weeks
Secondary	Percent change in PASI From Baseline to Week 36		From Baseline through 36 weeks