New oral pill HPP737 aims to clear psoriasis in phase 3 trial

NCT ID NCT07712705

Disease control Sponsor: Newsoara Biopharma Co., Ltd. Source: ClinicalTrials.gov ↗

First seen Jul 17, 2026 · Last updated Aug 04, 2026 · Updated 2 times

Summary

This Phase 3 trial tests whether an oral drug called HPP737 can safely improve moderate-to-severe plaque psoriasis in adults. Participants take HPP737 or a placebo daily for 16 weeks, with doctors measuring skin clearance using standard scores like PASI. The study aims to see if HPP737 helps more people achieve significant skin improvement compared to a placebo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: an experimental oral drug called HPP737
What this could lead to: If successful, HPP737 could offer a new oral treatment option for people with moderate-to-severe plaque psoriasis, potentially improving skin clearance and quality of life.
What could go wrong: This is a Phase 3 trial, but results may not confirm benefit over placebo. Side effects are possible, and the drug may not work for everyone or may have safety issues.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

515 people

The number who actually took part.

Started

Apr 2023

Finished

Feb 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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.);

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Conditions

The condition(s) this trial relates to.

psoriasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Psoriasis

Contacts and locations

Locations

Affiliated Hospital of Chengde Medical College

Chengde, China
Affiliated Hospital of Guilin Medical University

Guilin, China
Affiliated Hospital of Jiangsu University

Zhenjiang, China
Affiliated Hospital of Tianjin Academy of Traditional Chinese Medicine

Tianjin, China
Beijing Friendship Hospital, Capital Medical University

Beijing, China
Beijing Tongren Hospital, Capital Medical University

Beijing, China
Cangzhou People's Hospital

Cangzhou, China
Chengdu Second People's Hospital

Chengdu, China
Dermatology Hospital, Southern Medical University

Guangzhou, China
Dongguan First People's Hospital

Dongguan, China
General Hospital of Ningxia Medical University

Yinchuan, China
Guangdong Provincial People's Hospital

Guangzhou, China
Hangzhou First People's Hospital

Hangzhou, China
Hangzhou Third People's Hospital

Hangzhou, China
Jiangxi Provincial Dermatology Hospital

Nanchang, China
Jiangyin Hospital of Traditional Chinese Medicine

Wuxi, China
Jiaxing First Hospital

Jiaxing, China
Jinan Central Hospital

Jinan, China
Nanyang Central Hospital

Nanyang, China
Nanyang First People's Hospital

Nanyang, China
Peking University People's Hospital

Beijing, China
Shandong Provincial Hospital

Jinan, China
Shandong Provincial Hospital of Dermatology

Guiyang, China
Shandong Provincial Hospital of Dermatology

Jinan, China
Shanghai Skin Disease Hospital

Shanghai, China
Shengli Oilfield Central Hospital

Dongying, China
Shiyan People's Hospital

Shiyan, China
Suining Central Hospital

Suining, China
The First Affiliated Hospital of Bengbu Medical College

Bengbu, China
The First Affiliated Hospital of Gannan Medical University

Gannan, China
The First Affiliated Hospital of Kunming Medical University

Kunming, China
The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China
The First Hospital of Hebei Medical University

Shijiazhuang, China
The First People's Hospital of Lianyungang

Lianyungang, China
The Second Affiliated Hospital of Harbin Medical University

Harbin, China
The Second Affiliated Hospital of Xiamen Medical College

Xiamen, China
The Second Hospital of Jilin University

Changchun, China
The Second Xiangya Hospital of Central South University

Changsha, China
The Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, China
The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, China
The Third Xiangya Hospital of Central South University

Changsha, China
Wuhan First Hospital

Wuhan, China
Wuxi Second People's Hospital

Wuxi, China
Xiangya Hospital, Central South University

Changsha, China
Xianyang Hospital of Yan'an University

Xianyang, China
Yancheng No.1 People's Hospital

Yancheng, China
Yantai Yuhuangding Hospital

Yantai, China
Yijishan Hospital of Wannan Medical College

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

Shanghai, China
Zhejiang Provincial People's Hospital

Hangzhou, China

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