Status:
RECRUITING
A Phase 2 Study of HB0017 in Psoriasis Patients
Lead Sponsor:
Huabo Biopharm Co., Ltd.
Conditions:
Psoriasis (PsO)
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 moder...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 30 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06592274
Start Date
September 30 2024
End Date
January 30 2026
Last Update
September 15 2025
Active Locations (18)
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1
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
2
Southern Medical University Dermatology Hospital
Guangzhou, Guangdong, China
3
Xiangya Hospital of Central South University
Changsha, Hunan, China
4
Wuxi Second People's Hospital
Wuxi, Jiangsu, China