Study of Efficacy and Safety of HB0017 in Patients With Moderate to Severe Plaque Psoriasis
ConditionPsoriasis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHuabo Biopharm Co., Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- HB0017 Q4W
- HB0017 Q8W
- placebo
Treatment groups
400 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov