HPP737 in Adult Patients With Plaque Psoriasis
brief summary
The goal of this clinical trial is to learn if drug HPP737 works to treat moderate-to-severe plaque psoriasis in adults. It will also learn about the safety of drug HPP737. The main questions it aims to answer are: Does drug HPP737 improve psoriasis severity compared to an active control drug, as measured by the proportion of patients achieving a significant reduction in the Psoriasis Area and Severity Index (PASI) score and other standardized assessments? What medical problems do participants have when taking drug HPP737? Researchers will compare drug HPP737 to an active control drug (a positive drug comparator) to see if drug HPP737 works to treat moderate-to-severe plaque psoriasis. This is a multicenter, randomized, double-blind, double-dummy, active-controlled Phase III clinical trial. Participants will: Take drug HPP737 or an active control drug orally every day Visit the clinic regularly for checkups and tests throughout the study Have their psoriasis severity assessed using standardized scoring tools, including the Psoriasis Area and Severity Index (PASI), static Physician's Global Assessment (sPGA), and Body Surface Area (BSA) The trial plans to enroll approximately 606 participants across about 61 centers in China. Eligible participants are adults aged 18 years and older with a confirmed diagnosis of stable moderate-to-severe plaque psoriasis for at least 6 months.
detailed description
This is a multicenter, randomized, double-blind, double-dummy, active parallel-controlled Phase III clinical trial evaluating the efficacy and safety of oral HPP737 in adult patients with moderate-to-severe chronic plaque psoriasis. The study is sponsored by Newsoara Biopharma Co., Ltd. (Shanghai) and has been approved by the National Medical Products Administration (NMPA) .
HPP737 is a novel, potent, and selective oral phosphodiesterase type 4 (PDE4) inhibitor in development for the treatment of psoriasis. PDE4 is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases the production of anti-inflammatory mediators, making it a validated therapeutic target for inflammatory diseases such as psoriasis. Preclinical and early clinical data indicate that HPP737 has demonstrated potent inhibition of interleukin-23 (IL-23) and tumor necrosis factor-alpha (TNF-α) production. HPP737 is designed to preferentially inhibit PDE4B, which is associated with anti-inflammatory activity, while limiting PDE4D engagement, which is believed to drive dose-limiting side effects, such as gastrointestinal distress. In Phase I studies, HPP737 was generally well-tolerated with a favorable safety profile.
Study Design: This study consists of three periods: a Screening Period, a Treatment Period, and a Safety Follow-up Period.
Screening Period (Day -14 to Day -1): Potential participants undergo screening procedures to assess eligibility based on inclusion and exclusion criteria.
Treatment Period (Week 0 to Week 16): Eligible participants are randomized in a 2:1 ratio to receive one of the following double-blind, double-dummy treatments for 16 weeks:
HPP737 20 mg orally once daily (experimental group, n≈404) Apremilast (active comparator) orally twice daily according to its approved dosing regimen (active comparator group, n≈202) Safety Follow-up Period (14 days after last dose): Following the completion of the 16-week treatment period, participants enter a safety follow-up period. This follow-up visit occurs 14 days after the last dose of study medication.
Study Population: Approximately 606 participants are planned to be enrolled in China. Eligible participants are adults aged ≥18 years with a confirmed clinical diagnosis of stable moderate-to-severe chronic plaque psoriasis and a history of psoriasis of at least 6 months.
Primary Objectives:
official title
A Multicenter, Randomized, Double-blind, Double-dummy, Active Drug Parallel-controlled Phase III Clinical Trial Evaluating the Efficacy and Safety of Oral HPP737 in Adult Patients With Moderate to Severe Plaque Psoriasis.