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PsoriasisPhase 3NCT07712705

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

A Phase 3 study testing HPP737 in people with Psoriasis, run by Newsoara Biopharma Co., Ltd. at 50 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psoriasis
What is being tested?
HPP737
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
515 participants
Where
50 sitesChina
Study dates
20 Apr 2023to 20 Feb 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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;
Show all 13Show fewer
  • 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.);

Trial locations and contacts

50 sites in 1 country.

50 sites in 1 country

China50 sites

  • Beijing Friendship Hospital, Capital Medical University

    Beijing

  • Beijing Tongren Hospital, Capital Medical University

    Beijing

  • Peking University People's Hospital

    Beijing

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu

  • Cangzhou People's Hospital

    Cangzhou

  • The Second Hospital of Jilin University

    Changchun

  • The Second Xiangya Hospital of Central South University

    Changsha

  • The Third Xiangya Hospital of Central South University

    Changsha

  • Xiangya Hospital, Central South University

    Changsha

  • Affiliated Hospital of Chengde Medical College

    Chengde

  • Chengdu Second People's Hospital

    Chengdu

  • Dongguan First People's Hospital

    Dongguan

  • Shengli Oilfield Central Hospital

    Dongying

  • The First Affiliated Hospital of Gannan Medical University

    Gannan

  • Dermatology Hospital, Southern Medical University

    Guangzhou

  • Guangdong Provincial People's Hospital

    Guangzhou

  • The Sixth Affiliated Hospital of Sun Yat-sen University

    Guangzhou

  • The Third Affiliated Hospital of Sun Yat-sen University

    Guangzhou

  • Affiliated Hospital of Guilin Medical University

    Guilin

  • Shandong Provincial Hospital of Dermatology

    Guiyang

  • Hangzhou First People's Hospital

    Hangzhou

  • Hangzhou Third People's Hospital

    Hangzhou

  • Zhejiang Provincial People's Hospital

    Hangzhou

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin

  • Jiaxing First Hospital

    Jiaxing

  • Jinan Central Hospital

    Jinan

  • Shandong Provincial Hospital of Dermatology

    Jinan

  • Shandong Provincial Hospital

    Jinan

  • The First Affiliated Hospital of Kunming Medical University

    Kunming

  • The First People's Hospital of Lianyungang

    Lianyungang

  • Jiangxi Provincial Dermatology Hospital

    Nanchang

  • Nanyang Central Hospital

    Nanyang

  • Nanyang First People's Hospital

    Nanyang

  • Shanghai Skin Disease Hospital

    Shanghai

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

    Shanghai

  • The First Hospital of Hebei Medical University

    Shijiazhuang

  • Shiyan People's Hospital

    Shiyan

  • Suining Central Hospital

    Suining

  • Affiliated Hospital of Tianjin Academy of Traditional Chinese Medicine

    Tianjin

  • Wuhan First Hospital

    Wuhan

  • Yijishan Hospital of Wannan Medical College

    Wuhu

  • Jiangyin Hospital of Traditional Chinese Medicine

    Wuxi

  • Wuxi Second People's Hospital

    Wuxi

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an

  • The Second Affiliated Hospital of Xiamen Medical College

    Xiamen

  • Xianyang Hospital of Yan'an University

    Xianyang

  • Yancheng No.1 People's Hospital

    Yancheng

  • Yantai Yuhuangding Hospital

    Yantai

  • General Hospital of Ningxia Medical University

    Yinchuan

  • Affiliated Hospital of Jiangsu University

    Zhenjiang

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of Oral HPP737 in Adult Patients With Moderate-to-severe Plaque Psoriasis.

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.

Read more

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.

Read the detailed description

HPP737-Psoriasis-301 is a phase III, multicenter, randomized, double-blind, parallel-group, placebo-controlled trial designed to evaluate the efficacy and safety of oral HPP737 in adult patients with moderate-to-severe plaque psoriasis. The study is sponsored by Newsoara Biopharma Co., Ltd. The trial involves approximately 504 patients across multiple centers nationwide.

HPP737 is a novel, potent, orally administered, and selective phosphodiesterase type 4 (PDE4) inhibitor. PDE4 is a validated therapeutic target for inflammatory diseases including psoriasis. By inhibiting PDE4, HPP737 raises intracellular cyclic adenosine monophosphate (cAMP) levels, thereby exerting broad anti-inflammatory effects. Preclinical and clinical data have demonstrated that HPP737 potently inhibits interleukin-23 (IL-23) and tumor necrosis factor alpha (TNF-α) production both in vitro and in vivo. Notably, HPP737 has shown a favorable safety and tolerability profile in phase I studies, with no dose-limiting gastrointestinal side effects-such as nausea, vomiting, or diarrhea-commonly associated with other PDE4 inhibitors.

This is a randomized, double-blind, placebo-controlled, parallel-group trial. Eligible patients are adults aged ≥18 years with a confirmed diagnosis of stable chronic plaque psoriasis for ≥6 months and moderate-to-severe disease at screening, defined by Psoriasis Area and Severity Index (PASI) score ≥12, static Physician's Global Assessment (sPGA) score ≥3, and body surface area (BSA) involvement ≥10%. Patients are randomized in a 1:1:1 ratio to one of three treatment arms: HPP737 10 mg once daily, HPP737 20 mg once daily, or placebo.

The total treatment duration is 52 weeks, divided into two phases:

Core Phase (Weeks 0-16): Patients receive double-blind treatment with HPP737 10 mg, HPP737 20 mg, or placebo.

Extension Phase (Weeks 16-52): Patients who complete the core phase enter the extension phase. Those originally assigned to placebo are switched to HPP737 20 mg; patients in the HPP737 10 mg and 20 mg groups continue on their assigned doses without adjustment.

The primary objective is to evaluate the efficacy of HPP737 compared with placebo at Week 16 in patients with moderate-to-severe plaque psoriasis. Secondary objectives include: (1) evaluation of additional efficacy characteristics of HPP737 versus placebo; (2) assessment of the safety of HPP737 in patients with moderate-to-severe chronic plaque psoriasis; and (3) evaluation of population pharmacokinetic (PPK) characteristics of HPP737 in this patient population.

The study is conducted in accordance with Good Clinical Practice guidelines and the Declaration of Helsinki.

Conditions
Psoriasis
Being tested
HPP737, Placebo matching HPP737
Keywords
Moderate-to-severe plaque psoriasis
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HPP737Drug

    HPP737 capsule for oral administration

  • Placebo matching HPP737Drug

    Also called Placebo

    Placebo capsules matching HPP737 for oral administration

Study groups in NCT07712705
Study groupRoleWhat they receive
HPP737 10 mgExperimentalSpecification: 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.
Receives: Drug: HPP737
HPP737 20 mgExperimentalSpecification: 10 mg Dosage and Administration: Two capsules (two with 10 mg HPP737) are administered orally once daily for a total duration of 52 weeks.
Receives: Drug: HPP737
Placebo (cross over to HPP737 20mg at Week 17)Placebo comparatorSpecification: 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.
Receives: Drug: HPP737; Drug: Placebo matching HPP737

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: From enrollment to end of treatment at 16 weeks

Secondary outcomes (11)

  1. 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.

    Measured: From enrollment to end of treatment at 16 weeks

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. To evaluate the change from baseline in PASI(Psoriasis Area and Severity Index) score and the percent change from baseline at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52.

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

  7. To evaluate the proportion of subjects who achieve a sPGA score of 0 (clear) or 1 (almost clear) and who have a reduction of ≥2 points from baseline at Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, and 52.

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

  8. To evaluate the change from baseline in BSA and the percent change from baseline at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52.

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

  9. To evaluate the change from baseline in DLQI and the percent change from baseline at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52.

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

  10. To evaluate the incidence and severity of adverse events.

    Number and percentage of participants with treatment-emergent adverse events (TEAEs), graded by severity according to CTCAE 5.0.

    Measured: From ICF signed to end of study follow-up (at 54 weeks).

  11. To evaluate the pharmacokinetic profile (including plasma concentrations and derived parameters) over time at Weeks 0, 2, 4, 8, and 12.

    Measured: From enrollment to end of treatment at 2,4,8,12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2026
  2. Study start20 Apr 2023
  3. Primary completion29 Sep 2023
  4. Study completion20 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
515 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07712705
Sponsor's protocol ID
HPP737-Psoriasis-301
Status last verified
Jul 2026
First submitted
7 Jul 2026
Last updated
3 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HPP737 in people with Psoriasis, run by Newsoara Biopharma Co., Ltd. at 50 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: From enrollment to end of treatment at 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07712705.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.

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