New oral pill HPP737 takes on psoriasis in Head-to-Head trial

NCT ID NCT07712731

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 experimental oral drug, HPP737, can reduce psoriasis severity in adults with moderate-to-severe plaque psoriasis. Participants take HPP737 or an active control drug daily for 16 weeks. Researchers measure skin clearance using standard scores like PASI and sPGA to compare effectiveness and monitor safety.

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.
What could go wrong: This is a Phase 3 trial, but results may not show superiority over existing treatments. Side effects and long-term safety are still being evaluated.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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

607 people

The number who actually took part.

Started

Apr 2025

Finished

Apr 2026

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 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. Exclusion Criteria: * 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; * Medical history, symptoms, and examination results during screening indicating that the subject has active tuberculosis (TB); Note: Subjects with a negative T-cell test for Mycobacterium tuberculosis infection (T-SPOT test) during the screening period are eligible for inclusion in this study. Subjects with a positive T-SPOT result during the screening period are required to undergo TB-related clinical evaluation (TB-related clinical evaluations conducted within 12 weeks prior to randomization may be directly utilized for assessment). If the TB-related clinical evaluation confirms active tuberculosis, the subject shall not be enrolled in this study; if the evaluation confirms non-active tuberculosis, the subject may be included. If the study center is unable to perform the T-SPOT test, an interferon-gamma release assay (IGRA) may also be used for TB screening, and the handling of IGRA results should follow the same procedures as for the T-SPOT test. * 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;

Get updates

Get notified about this study

Our safety recommendation!

By submitting, you agree to our Terms of use

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 Central Hospital of Shenyang Medical College

Shengyang, China
Affiliated Hospital of Chengde Medical College

Chengde, China
Affiliated Hospital of Guilin Medical University

Guilin, China
Affiliated Hospital of Jiangsu University

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

Tianjin, China
Affiliated Hospital of Zunyi Medical University

Zunyi, China
Beijing Friendship Hospital, Capital Medical University

Beijing, China
Beijing Tongren Hospital, Capital Medical University

Beijing, China
Beijing Tsinghua Changgung Hospital

Beijing, China
Cangzhou People's Hospital

Cangzhou, China
Changde First People's Hospital

Changde, China
Chengdu Second People's Hospital

Chengdu, China
Dalian Dermatology Hospital

Dalian, China
Dermatology Hospital, Shandong First Medical University

Jinan, China
Dermatology Hospital, Southern Medical University

Guangzhou, China
First Affiliated Hospital of Chongqing Medical University

Chongqing, China
First Affiliated Hospital of Ningbo University

Ningbo, China
First Affiliated Hospital of Wenzhou Medical University

Wenzhou, China
First Hospital of Shanxi Medical University

Taiyuan, China
General Hospital of Ningxia Medical University

Yinchuan, China
Guangzhou First People's Hospital

Guangzhou, China
Hainan Fifth People's Hospital

Haikou, China
Hangzhou First People's Hospital

Hangzhou, China
Hospital of Dermatology, Chinese Academy of Medical Sciences

Nanjing, China
Huashan Hospital, Fudan University

Shanghai, China
Inner Mongolia Baogang Hospital

Baotou, China
Jiangxi Provincial Dermatology Hospital

Nanchang, China
Jinan Central Hospital

Jinan, China
Jingzhou Central Hospital

Jingmen, China
Lianyungang First People's Hospital

Lianyungang, China
Liaocheng People's Hospital

Liaocheng, China
Liaoning Provincial People's Hospital

Shenyang, China
Meihekou Central Hospital

Tonghua, China
Peking University People's Hospital

Beijing, China
Qingdao Traditional Chinese Medicine Hospital (Hai Ci Hospital)

Qingdao, China
Qujing First People's Hospital

Qujing, China
Second Affiliated Hospital of Chongqing Medical University

Chongqing, China
Second Affiliated Hospital of Nanchang University

Nanchang, China
Second Affiliated Hospital of Wannan Medical College

Wuhu, China
Shandong Provincial Hospital

Jinan, China
Shanghai Skin Disease Hospital

Shanghai, China
Shenyang Hospital of Integrated Traditional Chinese and Western Medicine

Shenyang, China
Shenzhen Second People's Hospital

Shenzhen, China
Shiyan People's Hospital

Shiyan, China
Sichuan Provincial People's Hospital

Chengdu, China
Suining Central Hospital

Suining, China
The Affiliated Hospital of Xuzhou Medical University

Xuzhou, China
The First Affiliated Hospital of Kunming Medical University

Kunming, China
The First Hospital of Hebei Medical University

Shijiazhuang, China
The Second Affiliated Hospital of Harbin Medical University

Harbin, China
The Second Hospital of Jilin University

Changchun, China
The Second People's Hospital of Changzhi

Changzhi, China
Third Xiangya Hospital of Central South University

Changsha, China
Wuhan No.1 hospital

Wuhan, China
Wuxi Second People's Hospital

Wuxi, China
Xingtai People's Hospital

Xingtai, China
Yancheng First People's Hospital

Yancheng, China
Zhejiang Provincial People's Hospital

Hangzhou, China
Zhongyi Northeast International Hospital Co., Ltd.

Shengyang, China
Zhujiang Hospital of Southern Medical University

Guangzhou, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.