HPP737 in Adult Patients With Plaque Psoriasis
A Multicenter, Randomized, Double-blind, Double-dummy, Active Drug Parallel-controlled Phase III Clinical Trial Evaluating the Efficacy and Safety of Oral HPP737 in Adult Patients With Moderate to Severe Plaque Psoriasis.
1 other identifier
interventional
607
1 country
60
Brief 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 an active control drug, as measured by the proportion of patients achieving a significant reduction in the Psoriasis Area and Severity Index (PASI) score and other standardized assessments? What medical problems do participants have when taking drug HPP737? Researchers will compare drug HPP737 to an active control drug (a positive drug comparator) to see if drug HPP737 works to treat moderate-to-severe plaque psoriasis. This is a multicenter, randomized, double-blind, double-dummy, active-controlled Phase III clinical trial. Participants will: Take drug HPP737 or an active control drug orally every day Visit the clinic regularly for checkups and tests throughout the study Have their psoriasis severity assessed using standardized scoring tools, including the Psoriasis Area and Severity Index (PASI), static Physician's Global Assessment (sPGA), and Body Surface Area (BSA) The trial plans to enroll approximately 606 participants across about 61 centers in China. Eligible participants are adults aged 18 years and older with a confirmed diagnosis of stable moderate-to-severe plaque psoriasis for at least 6 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2025
Shorter than P25 for phase_3
60 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 18, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2026
CompletedFirst Submitted
Initial submission to the registry
July 7, 2026
CompletedFirst Posted
Study publicly available on registry
July 17, 2026
CompletedJuly 17, 2026
July 1, 2026
12 months
July 7, 2026
July 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
To evaluate proportion of subjects at Week 16 achieving at least a 75% reduction(improvement) from baseline in PASI (Psoriasis Area and Severity Index) score (PASI 75);
From enrollment to end of treatment at 16 weeks
To evaluate proportion of subjects at Week 16 achieving sPGA (Static Physician's Global Assessment) rating of "clear (score 0) or almost clear (score 1)"
From enrollment to end of treatment at 16 weeks
Secondary Outcomes (10)
To evaluate proportion of subjects achieving PASI 75 response at Week 1, 2, 4, 8, and 12;
From enrollment to end of treatment at 1, 2, 4, 8, and 12 weeks
To evaluate proportion of subjects achieving at least a 50% reduction in PASI (PASI 50) at Week 1, 2, 4, 8, 12, and 16;
From enrollment to end of treatment at 1, 2, 4, 8, 12, and 16 weeks
To evaluate proportion of subjects achieving at least a 90% reduction in PASI (PASI 90) at Week 1, 2, 4, 8, 12, and 16;
From enrollment to end of treatment at 1, 2, 4, 8, 12, and 16 weeks
To evaluate proportion of subjects achieving at least a 100% reduction in PASI (PASI 100) at Week 1, 2, 4, 8, 12, and 16;
From enrollment to end of treatment at 1, 2, 4, 8, 12, and 16 weeks.
To evaluate change from baseline in PASI score, and percent change from baseline in PASI score at Week 1, 2, 4, 8, 12, and 16;
From enrollment to end of treatment at 1, 2, 4, 8, 12, and 16 weeks
- +5 more secondary outcomes
Study Arms (2)
HPP737 20mg
EXPERIMENTALSpecification:10mg; Participants receive HPP737 20 mg orally once daily for 16 weeks.
Aprmilast 30mg Bid
ACTIVE COMPARATORParticipants receive Apremilast for 16 weeks. According to product label, 5-day dose titration is required: Day 1: 10 mg in the morning; Day 2: 10 mg in the morning and 10 mg in the evening; Day 3: 10 mg in the morning and 20 mg in the evening; Day 4: 20 mg in the morning and 20 mg in the evening; Day 5: 20 mg in the morning and 30 mg in the evening; Day 6 and thereafter: 30 mg twice daily (morning and evening, approximately 12 hours apart).
Interventions
Placebo capsules matching HPP737 for oral administration.
Placebo tablets matching Apremilast for oral administration.
Eligibility Criteria
You may qualify if:
- Subjects must voluntarily sign the informed consent form prior to the initiation of any trial-related procedures, be able to communicate effectively with the investigators, and understand and comply with the requirements of this trial;
- Age at the time of signing the informed consent form: age ≥18 years, regardless of sex;
- Clinically diagnosed patients with stable plaque psoriasis (Zhendingxing Banquzhuang Yinxie Bing), with a psoriasis history of ≥6 months before randomization;
- Diagnosed with moderate to severe plaque psoriasis and meeting the following criteria at screening: 1) PASI (Psoriasis Area and Severity Index), score ≥10; and sPGA (Static Physician's Global Assessment) score ≥3; and BSA (Body Surface Area) score ≥10%
- Body Mass Index (BMI): 18 kg/m2 ≤ BMI ≤ 35 kg/m2.
You may not qualify if:
- Presence of other forms of psoriasis (e.g., guttate psoriasis, pustular psoriasis, erythrodermic psoriasis) diagnosed at screening, in addition to chronic plaque psoriasis;
- Patients with drug-induced psoriasis (including but not limited to newly onset or exacerbated psoriasis caused by β-blockers \[beta-receptor blockers\], calcium channel blockers, or lithium preparations)
- Subjects with other skin diseases that may interfere with clinical assessment (such as severe bacterial, fungal, or viral skin infections), chronic diarrhea, severe gastrointestinal diseases (such as active peptic ulcer, gastrointestinal tract disorders, etc.), or a history of inflammatory bowel disease (Crohn's disease, ulcerative colitis, etc.), or other active autoimmune inflammatory diseases (mixed connective tissue disease, idiopathic inflammatory myopathy, etc.);
- History of congenital or acquired immunodeficiency;
- Severe infection or systemic infection within 4 weeks prior to randomization, requiring oral and/or intravenous anti-infective therapy; or hospitalization due to infection;
- History of moderate to severe heart failure (New York Heart Association \[NYHA\] functional classification ≥ Class III), or occurrence of cardiovascular or cerebrovascular events or other serious events within 3 months prior to randomization, as judged by the investigator to be unsuitable for participation in this clinical trial;
- History of malignancy in any organ system within 5 years prior to randomization, except for malignancies with low risk of metastasis and death, such as adequately treated carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin, etc.;
- History of depression and/or suicidal ideation or any suicidal behavior at screening or baseline based on Columbia-Suicide Severity Rating Scale (C-SSRS) assessment (Appendix 6). If the subject answers "Yes" to any question on the C-SSRS questionnaire, or if the investigator assesses clinical risk, these subjects will be excluded;
- Presence of clinically severe, progressive, or uncontrolled diseases during the screening period, including but not limited to the respiratory system, cardiovascular system, endocrine system, hematological system, skeletal system, and nervous system, where participation in the trial may pose unacceptable risk to the subject or interfere with interpretation of data, as assessed by the investigator;
- Use of the following psoriasis (Yinxie Bing) treatments/medications prior to randomization: 1) Within 2 weeks prior to randomization, the subject has received topical treatment for psoriasis, such as glucocorticoids, vitamin D3 derivatives, or retinoids. However, subjects are permitted to use the following topical treatments: non-medicated shampoos and emollients (i.e., those not containing glucocorticoids or vitamin D3 derivatives). Within 4 weeks prior to randomization, the subject has received phototherapy/photochemotherapy (including but not limited to psoralen and ultraviolet A (PUVA) phototherapy, ultraviolet B (UVB)) or non-biologic systemic therapies (including but not limited to systemic glucocorticoids, leflunomide, cyclophosphamide, azathioprine, methotrexate, cyclosporin, retinoids, mycophenolate mofetil, traditional Chinese medicines for the treatment of psoriasis, or other small-molecule targeted agents for the treatment of psoriasis). Tumor necrosis factor-α (TNF-α) antagonists: (1) Use of a TNF-α antagonist (e.g., adalimumab, infliximab, golimumab, etanercept, certolizumab pegol) within a specified period prior to randomization (such as within 12 weeks before randomization); (2) or history of prior use of two or more TNF-α antagonists before randomization; 4) Within 24 weeks prior to randomization, the subject has used other biologic agents, including but not limited to IL-17 inhibitors, IL-23 inhibitors, or IL-12/IL-23 inhibitor class drugs.
- Receipt of a live attenuated vaccine within 12 weeks prior to randomization, or planned receipt of a live attenuated vaccine during the trial period;
- Subjects who previously had poor efficacy with other PDE4 (phosphodiesterase-4) inhibitors (such as apremilast, Hemay005, etc.)
- Participation in and receipt of any interventional clinical trial treatment within 1 month prior to randomization;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (60)
Inner Mongolia Baogang Hospital
Baotou, China
Beijing Friendship Hospital, Capital Medical University
Beijing, China
Beijing Tongren Hospital, Capital Medical University
Beijing, China
Beijing Tsinghua Changgung Hospital
Beijing, China
Peking University People's Hospital
Beijing, China
Cangzhou People's Hospital
Cangzhou, China
The Second Hospital of Jilin University
Changchun, China
Changde First People's Hospital
Changde, China
Third Xiangya Hospital of Central South University
Changsha, China
Changzhi Second People's Hospital
Changzhi, China
Affiliated Hospital of Chengde Medical College
Chengde, China
Chengdu Second People's Hospital
Chengdu, China
Sichuan Provincial People's Hospital
Chengdu, China
First Affiliated Hospital of Chongqing Medical University
Chongqing, China
Second Affiliated Hospital of Chongqing Medical University
Chongqing, China
Dalian Dermatology Hospital
Dalian, China
Dermatology Hospital, Southern Medical University
Guangzhou, China
Guangzhou First People's Hospital
Guangzhou, China
Zhujiang Hospital of Southern Medical University
Guangzhou, China
Affiliated Hospital of Guilin Medical University
Guilin, China
Hainan Fifth People's Hospital
Haikou, China
Hangzhou First People's Hospital
Hangzhou, China
Zhejiang Provincial People's Hospital
Hangzhou, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, China
Dermatology Hospital, Shandong First Medical University
Jinan, China
Jinan Central Hospital
Jinan, China
Shandong Provincial Hospital
Jinan, China
Jingzhou Central Hospital
Jingmen, China
The First Affiliated Hospital of Kunming Medical University
Kunming, China
Lianyungang First People's Hospital
Lianyungang, China
Liaocheng People's Hospital
Liaocheng, China
Jiangxi Provincial Dermatology Hospital
Nanchang, China
Second Affiliated Hospital of Nanchang University
Nanchang, China
Hospital of Dermatology, Chinese Academy of Medical Sciences
Nanjing, China
First Affiliated Hospital of Ningbo University
Ningbo, China
Qingdao Traditional Chinese Medicine Hospital (Hai Ci Hospital)
Qingdao, China
Qujing First People's Hospital
Qujing, China
Huashan Hospital, Fudan University
Shanghai, China
Shanghai Skin Disease Hospital
Shanghai, China
Affiliated Central Hospital of Shenyang Medical College
Shengyang, China
Zhongyi Northeast International Hospital Co., Ltd.
Shengyang, China
Liaoning Provincial People's Hospital
Shenyang, China
Shenyang Hospital of Integrated Traditional Chinese and Western Medicine
Shenyang, China
Shenzhen Second People's Hospital
Shenzhen, China
The First Hospital of Hebei Medical University
Shijiazhuang, China
Shiyan People's Hospital
Shiyan, China
Suining Central Hospital
Suining, China
First Hospital of Shanxi Medical University
Taiyuan, China
Affiliated Hospital of Tianjin Academy of Traditional Chinese Medicine
Tianjin, China
Meihekou Central Hospital
Tonghua, China
First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
Wuhan First Hospital
Wuhan, China
Second Affiliated Hospital of Wannan Medical College
Wuhu, China
Affiliated Hospital of Jiangsu University
Wuxi, China
Wuxi Second People's Hospital
Wuxi, China
Xingtai People's Hospital
Xingtai, China
Affiliated Hospital of Xuzhou Medical University
Xuzhou, China
Yancheng First People's Hospital
Yancheng, China
General Hospital of Ningxia Medical University
Yinchuan, China
Affiliated Hospital of Zunyi Medical University
Zunyi, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jianzhong Zhang
Peking University People's Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 7, 2026
First Posted
July 17, 2026
Study Start
April 18, 2025
Primary Completion
April 1, 2026
Study Completion
April 1, 2026
Last Updated
July 17, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share