HPP737 in Adult Patients With Moderate-to-severe Plaque Psoriasis.

NCT07712705 | Completed Phase 3 FDA Drug

• 1 other identifier: HPP737-Psoriasis-301
• Study Type: interventional
• Target: 515
• Locations: 1 country
• Sites: 50

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 a placebo at Week 16, as measured by the proportion of patients achieving a significant reduction in the Psoriasis Area and Severity Index (PASI) score? 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. This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial. 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, including the Psoriasis Area and Severity Index (PASI), static Physician's Global Assessment (sPGA), and Body Surface Area (BSA) Eligible participants are adults aged 18 years and older with a confirmed diagnosis of chronic plaque psoriasis for at least 6 months and moderate-to-severe disease at screening.

Conditions

Psoriasis

Keywords

Moderate-to-severe plaque psoriasis

Outcome Measures

Primary Outcomes (1)

• To evaluate the proportion of subjects who achieve PASI 75 (a ≥ 75% reduction (improvement) in the Psoriasis Area and Severity Index (PASI) score ）from baseline to Week 16

  From enrollment to end of treatment at 16 weeks

Secondary Outcomes (11)

• To evaluate the proportion of subjects who achieve a static Physician's Global Assessment (sPGA) score of 0 (clear) or 1 (almost clear) and who have a reduction of ≥2 points from baseline to Week 16.

  From enrollment to end of treatment at 16 weeks

• To evaluate the proportion of subjects who achieve PASI 75 (a ≥ 75% reduction (improvement) in the Psoriasis Area and Severity Index (PASI) score ）from baseline to Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, and 52.

  From enrollment to end of treatment at 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, and 52 weeks

• To evaluate the proportion of subjects who achieve PASI 50 (a ≥ 50% reduction (improvement) in the Psoriasis Area and Severity Index (PASI) score ）at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52.

  From enrollment to end of treatment at 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 weeks.

• To evaluate the proportion of subjects who achieve PASI 90 (a ≥ 90% reduction (improvement) in the Psoriasis Area and Severity Index (PASI) score ）from baseline to Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52.

  From enrollment to end of treatment at 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 weeks.

• To evaluate the proportion of subjects who achieve PASI 100 (a ≥ 100% reduction (improvement) in the Psoriasis Area and Severity Index (PASI) score ）from baseline to Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52.

  From enrollment to end of treatment at 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 weeks.

Study Arms (3)

HPP737 10 mg

EXPERIMENTAL

Specification: 10 mg Dosage and Administration: Two capsules (one with 10 mg HPP737 and one with 10 mg placebo) are administered orally once daily for a total duration of 52 weeks.

Drug: HPP737

HPP737 20 mg

EXPERIMENTAL

Specification: 10 mg Dosage and Administration: Two capsules (two with 10 mg HPP737) are administered orally once daily for a total duration of 52 weeks.

Drug: HPP737

Placebo (cross over to HPP737 20mg at Week 17)

PLACEBO COMPARATOR

Specification: 10 mg Administration and dosage: Two capsules (two with 10 mg placebo) are administered orally once daily for a total duration of 16 weeks. Then patients will be crossed over to receive HPP737 20 mg once daily starting at Week 17 and continuing through Week 52.

Drug: HPP737; Drug: Placebo matching HPP737

Interventions

HPP737 DRUG

HPP737 capsule for oral administration

HPP737 10 mg; HPP737 20 mg; Placebo (cross over to HPP737 20mg at Week 17)

Placebo matching HPP737 DRUG

Placebo capsules matching HPP737 for oral administration

Also known as: Placebo

Placebo (cross over to HPP737 20mg at Week 17)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects voluntarily sign the informed consent form before initiation of any study-related procedures, are able to communicate effectively with investigators, and understand and comply with all requirements of this study;
• Age at signing informed consent: age ≥18 years, regardless of gender;
• Diagnosed with a history of chronic plaque psoriasis (Psoriasis vulgaris) and disease stability for ≥6 months prior to screening;
• Diagnosed with moderate to severe plaque psoriasis (Psoriasis vulgaris), and at screening meets the following requirements: 1) PASI (Psoriasis Area and Severity Index) score ≥ 12; and 2) Static Physician Global Assessment (sPGA) score ≥ 3; and 3) Body Surface Area (BSA) involvement ≥ 10%;
• Body Mass Index (BMI): 18 kg/m2 ≤ BMI ≤ 35 kg/m2

You may not qualify if:

• At screening, diagnosis of psoriasis types other than chronic plaque psoriasis (Psoriasis vulgaris), e.g., pustular psoriasis (Psoriasis pustulosa), erythrodermic psoriasis (Psoriasis erythrodermica), and guttate psoriasis (Psoriasis guttata);
• Patients with drug-induced psoriasis (including but not limited to new-onset or exacerbation of psoriasis caused by β-blockers \[beta-blockers\], calcium channel inhibitors \[calcium channel blockers\], or lithium preparations \[lithium salts\]);
• Subjects have other skin diseases that may interfere with clinical assessment (e.g., bacterial, fungal, or viral skin infections, seborrheic dermatitis), chronic diarrhea, severe digestive diseases (such as active gastric ulcer, gastrointestinal tract disorders), or history of inflammatory bowel disease (Crohn's disease, ulcerative colitis), or other active autoimmune inflammatory diseases (mixed connective tissue disease, idiopathic inflammatory myopathy); Note: Chronic diarrhea is defined as disease course \>4 weeks, or recurrent diarrhea in a 2-4 week interval. Diarrhea refers to defecation significantly exceeding usual frequency (\>3 times/day), stool consistency is loose, water content (\>85%), and stool may contain mucus, pus, blood, or undigested food.
• History of congenital or acquired immunodeficiency;
• Severe infection or systemic infection within 4 weeks prior to randomization requiring oral and/or intravenous antimicrobial treatment, or hospitalization due to infection;
• At screening, subject's history, symptoms, and examination results indicate active tuberculosis;
• History of moderate-to-severe heart failure (New York Heart Association \[NYHA\] functional classification ≥ Class 3), or occurrence of cardiovascular or cerebrovascular events or severe events within 3 months prior to randomization, such that investigators consider these subjects 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 mortality, such as adequately treated carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin;
• Subjects with a history of depression and/or, as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) during the screening and baseline period, with ideation or any behavior (see Appendix 6). Subjects who answer "yes" to any question on the C-SSRS questionnaire, or those deemed at risk by the investigator's clinical judgment, will be excluded;
• Presence of clinically significant, progressive, or uncontrolled disease during the screening period, including but not limited to respiratory, cardiovascular, endocrine, hematologic, skeletal, or neurologic systems, as assessed by the investigator to pose unacceptable risk for participation or interfere with data interpretation;
• Prior to screening, use of the following psoriasis treatment modalities/drugs: 1) Received topical treatment for psoriasis within 2 weeks prior to randomization, such as glucocorticoids, vitamin D3 derivatives, retinoids, etc.; however, the subject is permitted to use the following topical treatments: non-medicated shampoos and emollients (i.e., those not containing glucocorticoids or vitamin D3 derivatives); Received phototherapy/photochemotherapy (including but not limited to psoralen plus ultraviolet A \[PUVA\] therapy, ultraviolet B \[UVB\]), or non-biological systemic therapy (including but not limited to systemic glucocorticoids, leflunomide, cyclophosphamide, azathioprine, methotrexate, cyclosporine, retinoids, mycophenolate mofetil, traditional Chinese medicine for the treatment of psoriasis, or other small-molecule targeted agents for the treatment of psoriasis) within 4 weeks prior to randomization; Tumor necrosis factor-alpha (TNF-α) antagonist: (1) The patient has used at least one TNF-α antagonist within the specified time period prior to randomization (for example, adalimumab, infliximab, golimumab, etanercept, or certolizumab pegol within 12 weeks prior to randomization); (2) or the patient has used two or more TNF-α antagonists prior to randomization; 4) Used other biologic agents within 24 weeks prior to randomization, including but not limited to anti-interleukin-17 (anti-IL-17) inhibitors, anti-interleukin-23 (anti-IL-23) inhibitors, anti-interleukin-12/interleukin-23 (anti-IL-12/23) inhibitors, and related agents;
• Receipt of live attenuated vaccines within 12 weeks prior to randomization, or planned vaccination with live attenuated vaccines during the study period;
• Subjects who have previously used other PDE4 inhibitors (such as apremilast, Hemay005, etc.);

Sponsors & Collaborators

• Newsoara Biopharma Co., Ltd.: lead

Study Sites (50)

Beijing Friendship Hospital, Capital Medical University

Beijing, China

Location

Beijing Tongren Hospital, Capital Medical University

Beijing, China

Location

Peking University People's Hospital

Beijing, China

Location

The First Affiliated Hospital of Bengbu Medical College

Bengbu, China

Location

Cangzhou People's Hospital

Cangzhou, China

Location

The Second Hospital of Jilin University

Changchun, China

Location

The Second Xiangya Hospital of Central South University

Changsha, China

Location

The Third Xiangya Hospital of Central South University

Changsha, China

Location

Xiangya Hospital, Central South University

Changsha, China

Location

Affiliated Hospital of Chengde Medical College

Chengde, China

Location

Chengdu Second People's Hospital

Chengdu, China

Location

Dongguan First People's Hospital

Dongguan, China

Location

Shengli Oilfield Central Hospital

Dongying, China

Location

The First Affiliated Hospital of Gannan Medical University

Gannan, China

Location

Dermatology Hospital, Southern Medical University

Guangzhou, China

Location

Guangdong Provincial People's Hospital

Guangzhou, China

Location

The Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, China

Location

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, China

Location

Affiliated Hospital of Guilin Medical University

Guilin, China

Location

Shandong Provincial Hospital of Dermatology

Guiyang, China

Location

Hangzhou First People's Hospital

Hangzhou, China

Location

Hangzhou Third People's Hospital

Hangzhou, China

Location

Zhejiang Provincial People's Hospital

Hangzhou, China

Location

The Second Affiliated Hospital of Harbin Medical University

Harbin, China

Location

Jiaxing First Hospital

Jiaxing, China

Location

Jinan Central Hospital

Jinan, China

Location

Shandong Provincial Hospital of Dermatology

Jinan, China

Location

Shandong Provincial Hospital

Jinan, China

Location

The First Affiliated Hospital of Kunming Medical University

Kunming, China

Location

Lianyungang First People's Hospital

Lianyungang, China

Location

Jiangxi Provincial Dermatology Hospital

Nanchang, China

Location

Nanyang Central Hospital

Nanyang, China

Location

Nanyang First People's Hospital

Nanyang, China

Location

Shanghai Skin Disease Hospital

Shanghai, China

Location

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of TCM

Shanghai, China

Location

The First Hospital of Hebei Medical University

Shijiazhuang, China

Location

Shiyan People's Hospital

Shiyan, China

Location

Suining Central Hospital

Suining, China

Location

Affiliated Hospital of Tianjin Academy of Traditional Chinese Medicine

Tianjin, China

Location

Wuhan First Hospital

Wuhan, China

Location

Yijishan Hospital of Wannan Medical College

Wuhu, China

Location

Jiangyin Hospital of Traditional Chinese Medicine

Wuxi, China

Location

Wuxi Second People's Hospital

Wuxi, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

Location

The Second Affiliated Hospital of Xiamen Medical College

Xiamen, China

Location

Xianyang Hospital of Yan'an University

Xianyang, China

Location

Yancheng First People's Hospital

Yancheng, China

Location

Yantai Yuhuangding Hospital

Yantai, China

Location

General Hospital of Ningxia Medical University

Yinchuan, China

Location

Affiliated Hospital of Jiangsu University

Zhenjiang, China

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jianzhong Zhang

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

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 20, 2023
• Primary Completion: September 29, 2023
• Study Completion: February 20, 2025
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (50)