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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
123
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.
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.
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.
Specification: 1 mg/capsule, 5 mg/capsule; Dosage and administration: 4 capsules (including 4 placebo capsules), oral use, once daily for 85 consecutive days.
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 for Skin Diseases, Shandong First Medical University
Jinan, China
The First People's Hospital of Lianyungang
Lianyungang, China
Hospital of Dermatology, Chinese Academy of Medical Sciences
Nanjing, China
Hong Kong University Shenzhen Hospital
Shenzhen, China
Wuxi No.2 People's Hospital
Wuxi, China
Proportion of subjects achieving at least a 75% improvement in the Psoriasis Area and Severity Index (PASI 75 response) from baseline at Day 85.
Time frame: 85 days
Proportion of subjects achieving a PASI 90 response at Day 85.
Time frame: 85 days
Incidence and severity of adverse events
including evaluate abnormal findings in vital signs, physical examination, electrocardiogram (ECG) and clinical laboratory tests
Time frame: 85 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.