Clinical trial NCT06592274: A Phase 2 Study to Explore the Efficacy and Safety of HB0017 Longer Dose Interval in Psoriasis Patients
Official title: A Multicenter, Randomized, Double-blind Phase 2 Clinical Study Evaluating the Efficacy and Safety of Different Administration Regimens of HB0017 Injection in Patients With Moderate to Severe Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Psoriasis (PsO)
Keywords: HB0017
psoriasis
longer dose regimen
Lead sponsor: Huabo Biopharm Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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) \&amp;gt;=12 and body surface area (BSA) affected by PSO \&amp;gt;=10% and Static Physician Global Assessment (sPGA) score \&amp;gt;=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

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 \&lt;28 days; infliximab and adalimumab \&lt;60 days; golimumab \&lt; 90 days; anti-IL-12/anti-IL-23 or anti-IL-23p19 antibody drugs \&lt;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

Primary outcomes:
measure: Proportion of subjects achieving PASI 90 response
timeFrame: Week 12
measure: Proportion of subjects achieving sPGA 0/1
timeFrame: Week 12
Secondary outcomes:
measure: Proportion of subjects achieving PASI 75 response
timeFrame: Week 12
measure: Proportion of subjects achieving PASI 100 response
timeFrame: Week 12
measure: PASI 90 response maintainance at week 48
timeFrame: Week12-48
measure: sPGA 0/1 response maintainance at week 48
timeFrame: Week12-48
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong First Medical University Affiliated Dermatology Hospital
state: Shandong
Study officials:
References: