RECRUITINGPhase 3INTERVENTIONAL
Study of Efficacy and Safety of HB0017 in Patients With Moderate to Severe Plaque Psoriasis
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of HB0017 Injection in Patients With Moderate to Severe Plaque Psoriasis
About This Trial
This is a multicenter, randomized, double-blind, placebo-controlled, phase III clinical study which is designed to determine the efficacy, safety, immunogenicity and pharmacokinetics, and pharmacodynamics of HB0017 Injection in the treatment of moderate to severe plaque psoriasis in adults.
Who May Be Eligible (Plain English)
Who May Qualify:
- Male or female subjects aged 18-75 years (inclusive)
- Chronic plaque psoriasis (PSO) for at least 6 months prior to the Randomization.
- Psoriasis Area Severity Index (PASI) \>=12 and body surface area (BSA) affected by PSO \>=10% and Static Physician Global Assessment (sPGA) score \>=3.
- Subjects who are suitable for systemic treatment or phototherapy for psoriasis as judged by the investigator
- Subjects who are able to use effective contraception from the screening period to 6 months after the last dose
Key Who Should NOT Join This Trial:
- Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and/or guttate psoriasis) at screening or baseline
- Drug-induced psoriasis
- Ongoing use of prohibited treatments
- Any active infection (other than common cold) within 14 days
- Serious infection defined as requiring hospitalization or iv anti-infective(s) within 1 month prior to randomization
- Have previously received any drug that directly targets IL-17 or IL-17 receptor
- Have concurrent or recent use of any biologic agent within the following waiting period after previous treatments: etanercept \<28 days; infliximab and adalimumab \<60 days; golimumab \< 90 days; anti-IL-12/anti-IL-23 or anti-IL-23p19 antibody drugs \<6 months; or other anti-psoriatic therapy not listed herein within its 5 half-lives prior to randomization
- A history of inflammatory bowel disease or other serious autoimmune conditions (where your immune system attacks your own body)
- Previously diagnosed with serious mental illness such as anxiety, depression or suicidal tendency
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* Male or female subjects aged 18-75 years (inclusive)
* Chronic plaque psoriasis (PSO) for at least 6 months prior to the Randomization.
* Psoriasis Area Severity Index (PASI) \>=12 and body surface area (BSA) affected by PSO \>=10% and Static Physician Global Assessment (sPGA) score \>=3.
* Subjects who are suitable for systemic treatment or phototherapy for psoriasis as judged by the investigator
* Subjects who are able to use effective contraception from the screening period to 6 months after the last dose
Key Exclusion Criteria:
* Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and/or guttate psoriasis) at screening or baseline
* Drug-induced psoriasis
* Ongoing use of prohibited treatments
* Any active infection (other than common cold) within 14 days
* Serious infection defined as requiring hospitalization or iv anti-infective(s) within 1 month prior to randomization
* Have previously received any drug that directly targets IL-17 or IL-17 receptor
* Have concurrent or recent use of any biologic agent within the following washout periods: etanercept \<28 days; infliximab and adalimumab \<60 days; golimumab \< 90 days; anti-IL-12/anti-IL-23 or anti-IL-23p19 antibody drugs \<6 months; or other anti-psoriatic therapy not listed herein within its 5 half-lives prior to randomization
* A history of inflammatory bowel disease or other serious autoimmune disease
* Previously diagnosed with serious mental illness such as anxiety, depression or suicidal tendency
Treatments Being Tested
BIOLOGICAL
HB0017 Q4W
HB0017 at W0,1,2,4,8+HB0017Q4W
BIOLOGICAL
HB0017 Q8W
HB0017 at W0,1,2,4,8+HB0017Q8W
BIOLOGICAL
placebo
placebo at W0,1,2,4,8+HB0017Q4W
Locations (20)
Jiangmen Central Hospital
Jiangmen, Guangdong, China
Nanyang First People's Hospital
Nanyang, Henan, China
Beijing Friendship Hospital
Beijing, China
China-Japan Friendship hospital
Beijing, China
Peking University People's Hospital
Beijing, China
The First Affiliated Hospital of Bengbu Medical College
Bengbu, China
Jilin University Second Hospital
Changchun, China
The first hospital of Jilin University
Changchun, China
Xiangya Hospital of Central South University
Changsha, China
Affiliated Hospital of Chengde Medical University
Chengde, China
Sichuan Provincial People's Hospital
Chengdu, China
West China Hospital of Sichuan University
Chengdu, China
Chongqing Traditional Chinese Medicine Hospital
Chongqing, China
Dongguan People's Hospital
Dongguan, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, China
Dermatology Hospital of Southern Medical University
Guangzhou, China
Guangdong Provincial People's Hospital
Guangzhou, China
Hangzhou First People's Hospital
Hangzhou, China
Hangzhou Third People's Hospital
Hangzhou, China
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, China