HPP737 in Adult Patients With Plaque Psoriasis
NCT07712731 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 607
Last updated 2026-08-03
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.
Conditions
Interventions
- DRUG
-
HPP737
HPP737 capsules for oral administration.
- DRUG
-
Placebo matching HPP737
Placebo capsules matching HPP737 for oral administration.
- DRUG
-
Apremilast
Apremilast tablets for oral administration.
- DRUG
-
Placebo matching Apremilast
Placebo tablets matching Apremilast for oral administration.
Sponsors & Collaborators
-
Newsoara Biopharma Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Jianzhong Zhang · Peking University People's Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-04-18
- Primary Completion
- 2026-04-01
- Completion
- 2026-04-01
- FDA Drug
- Yes
Countries
- China
Study Locations
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