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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HPP737 6 mg | Experimental |
| |
| HPP737 10 mg | Experimental |
| |
| HPP737 20 mg | Experimental |
| |
| HPP737 placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HPP737 6mg and placebo | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects achieving at least a 75% improvement in the Psoriasis Area and Severity Index (PASI 75 response) from baseline at Day 85. | 85 days |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects achieving a PASI 90 response at Day 85. | 85 days | |
| Incidence and severity of adverse events | including evaluate abnormal findings in vital signs, physical examination, electrocardiogram (ECG) and clinical laboratory tests |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heng Gu | Hospital of Dermatology, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Friendship Hospital, Capital Medical University | Beijing | China | ||||
| Beijing Tsinghua Changgung Hospital |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| HPP737 10mg and placebo | Drug | 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. |
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| HPP737 20mg | Drug | 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. |
|
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| HPP737 placebo | Drug | Specification: 1 mg/capsule, 5 mg/capsule; Dosage and administration: 4 capsules (including 4 placebo capsules), oral use, once daily for 85 consecutive days. |
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| 85 days |
| 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 |