Psoriasis
Conditions
Keywords
psoriasis; HB0017
Brief summary
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.
Interventions
BIOLOGICALHB0017 Q4W
HB0017 at W0,1,2,4,8+HB0017Q4W
BIOLOGICALHB0017 Q8W
HB0017 at W0,1,2,4,8+HB0017Q8W
BIOLOGICALplacebo
placebo at W0,1,2,4,8+HB0017Q4W
Sponsors
Huabo Biopharm Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects achieving PASI 75 response at Week 12 | Week 12 | The PASI75 response assessments are based on at least 75% improvement in PASI score from Baseline. |
| Proportion of subjects achieving sPGA 0/1 response at Week 12 | Week 12 | The sPGA is a physician's determination of the participant's psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis is assessed as clear (0), Almost clear (1), mild (2), moderate (3), severe (4). An sPGA 0/1 response was defined as a post-baseline sPGA score of 0 or 1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects achieving PASI 90 response at Week 12 | Week 12 | The PASI90 response assessments are based on at least 90% improvement in PASI score from Baseline. |
| PASI 90 response maintainance at week 52 | Week12-52 | Proportion of subjects maintaining PASI 90 response at Week 52 among those with PASI 90 response at Week 12 |
| sPGA 0/1 response maintainance at week 52 | Week 12-52 | Proportion of subjects maintaining sPGA 0/1 response at Week 52 among those with sPGA 0/1 response at Week 12. |
| PASI 75 response maintainance at week 52 | Week12-52 | Proportion of subjects maintaining PASI 75 response at Week 52 among those with PASI 75 response at Week 12. |
Countries
China
Contacts
Primary ContactJianzhong Zhang, MD
Outcome results
None listed