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Safety and Efficacy of HPP737 in Adult Patients With Plaque Psoriasis

NCT07707141 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 123

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 placebo, as measured by the proportion of patients achieving at least a 75% improvement in the Psoriasis Area and Severity Index (PASI 75) at Day 85? What medical problems do participants have when taking drug HPP737? Researchers will compare drug HPP737 to a placebo (a look-alike substance that contains no drug) to see if drug HPP737 works to treat moderate-to-severe plaque psoriasis.

Participants will:

Take drug HPP737 or a placebo orally every day Visit the clinic regularly for checkups and tests throughout the study Have their psoriasis severity assessed using standardized scoring tools (PASI, Physician's Global Assessment (PGA), and Body Surface Area ( BSA)) This is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical trial. Eligible participants are adults aged 18 to 70 years with chronic plaque psoriasis for at least 6 months and moderate-to-severe disease at screening.

Conditions

Interventions

DRUG

HPP737 6mg and placebo

Specification: 1 mg/capsule, 5 mg/capsule; Dosage and administration: 4 capsules (including 1 mg HPP737 drug × 1 capsule, 5 mg HPP737 × 1 capsule, 2 placebo capsules), oral use, once daily for 85 consecutive days.

DRUG

HPP737 10mg and placebo

Specification: 1 mg/capsule, 5 mg/capsule; Dosage and administration: 4 capsules (including 5 mg HPP737 × 2 capsule, 2 placebo capsules), oral use, once daily for 85 consecutive days.

DRUG

HPP737 20mg

Specification: 1 mg/capsule, 5 mg/capsule; Dosage and administration: 4 capsules (including 5 mg HPP737 ×4 capsules), oral use, once daily for 85 consecutive days.

DRUG

HPP737 placebo

Specification: 1 mg/capsule, 5 mg/capsule; Dosage and administration: 4 capsules (including 4 placebo capsules), oral use, once daily for 85 consecutive days.

Sponsors & Collaborators

  • Newsoara Biopharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Heng Gu · Hospital of Dermatology, Chinese Academy of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-03
Primary Completion
2021-12-20
Completion
2021-12-20
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 NCT07707141 on ClinicalTrials.gov