Plaque Psoriasis
Conditions
Keywords
HB0017, Chronic Plaque Psoriasis
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.
Interventions
OTHERPlacebo
Subjects will receive several injections of Placebo
DRUGHB0017
Subjects will receive HB0017 in different dosing regimens
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PASI 90 response | Week 12 | Proportion of subjects who achieve Psoriasis Area and Severity Index (PASI) 90 response or higher at week 12 |
| sPGA 0/1 response | Week 12 | Proportion of subjects who achieve static Physician Global Assessment (sPGA) 0 or 1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immunity | From baseline through 36 weeks | Number and proportion of subjects who developed anti-drug antibodies (ADAs) Following Study Treatment |
| PK characteristics | From Baseline through 36 weeks | Population pharmacokinetics (PK), Apparent Total Clearance (CL/F)， Apparent Volume of Distribution (V/F) of HB0017 |
| PASI responses up to 36 Weeks | From Baseline through 36 weeks | Proportion of subjects who achieve PASI 50, PASI 75, PASI 90 , PASI 100 response up to 36 weeks |
| PASI 75 response | Week 12 | Proportion of subjects who achieve PASI 75 response or higher |
| PD characterestics | From Baseline through 36 weeks | HB0017 concentrations in serum at different time points |
| PASI score change | From Baseline through 36 weeks | change in PASI From Baseline to Week 36 |
| Percent change in PASI | From Baseline through 36 weeks | Percent change in PASI From Baseline to Week 36 |
| sPGA 0/1 up to 36 Weeks | From Baseline through 36 weeks | Proportion of subjects who achieve |
| Adverse events | From baseline through 36 weeks | Treatment Related Adverse events (TEAEs)/serious adverse events (SAEs) |
Countries
China
Outcome results
None listed