HPP737 in Adult Patients With Plaque Psoriasis

NCT07712731 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 607

Last updated 2026-08-03

No results posted yet for this study

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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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07712731 on ClinicalTrials.gov