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Safety and Efficacy of HPP737 in Adult Patients With Plaque Psoriasis
Sponsor: Newsoara Biopharma Co., Ltd.
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
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.
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.
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.
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