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COMPLETED
NCT07707141
PHASE2

Safety and Efficacy of HPP737 in Adult Patients With Plaque Psoriasis

Sponsor: Newsoara Biopharma Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Safety and Efficacy of Oral HPP737 in Adult Patients With Moderate-to-severe Plaque Psoriasis

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

123

Start Date

2021-03-03

Completion Date

2021-12-20

Last Updated

2026-07-16

Healthy Volunteers

No

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.

Locations (8)

Beijing Friendship Hospital, Capital Medical University

Beijing, China

Beijing Tsinghua Changgung Hospital

Beijing, China

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, China

Shandong Provincial Hospital of Dermatology

Jinan, China

Lianyungang First People's Hospital

Lianyungang, China

Hospital of Dermatology, Chinese Academy of Medical Sciences

Nanjing, China

Hong Kong University Shenzhen Hospital

Shenzhen, China

Wuxi Second People's Hospital

Wuxi, China