A Phase 2 Study to Explore the Efficacy and Safety of HB0017 Longer Dose Interval in Psoriasis Patients
- Registration Number
- NCT06592274
- Lead Sponsor
- Huabo Biopharm Co., Ltd.
- Brief Summary
This study is a randomized, double-blind phase 2 clinical trial aimed at exploring the efficacy, safety, and immunogenicity of HB0017 injection with different dosing regimens in the treatment of moderate to severe plaque psoriasis in subjects
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental Group 3 HB0017 HB0017 low dose plus shortest dose regimen Experimental Group 1 HB0017 HB0017 higer dose plus longer dose regimen Experimental Group 2 HB0017 HB0017 higer dose plus shorter dose regimen
- Primary Outcome Measures
Name Time Method Proportion of subjects achieving PASI 90 response Week 12 The PASI75 response assessments are based on at least 90% improvement in PASI score from Baseline.
Proportion of subjects achieving sPGA 0/1 Week 12 The sPGA is a physician\&#39;s determination of the participant\&#39;s psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant\&#39;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 Outcome Measures
Name Time Method Proportion of subjects achieving PASI 75 response Week 12 The PASI75 response assessments are based on at least 75% improvement in PASI score from Baseline.
Proportion of subjects achieving PASI 100 response Week 12 The PASI100 response assessments are based on 100% improvement in PASI score from Baseline
PASI 90 response maintainance at week 48 Week12-48 Proportion of subjects maintaining PASI 90 response at Week 48 among those with PASI 90 response at Week 12
sPGA 0/1 response maintainance at week 48 Week12-48 Proportion of subjects maintaining sPGA 0/1 response at Week 48 among those with sPGA 0/1 response at Week 12.
Trial Locations
- Locations (1)
Shandong First Medical University Affiliated Dermatology Hospital
🇨🇳Jinan, Shandong, China