A Study to Evaluate the Efficacy and Safety of HB0017 in Patients With Moderate to Severe Plaque Psoriasis

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Huabo Biopharm Co., Ltd.

Criteria

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.