PsoriasisPhase 3NCT07712731
HPP737 in Adult Patients With Plaque Psoriasis
A Phase 3 study testing HPP737 and Apremilast in people with Psoriasis, run by Newsoara Biopharma Co., Ltd. at 60 sites in China.
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 an active control drug, 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 and Apremilast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 607 participants
- Where
- 60 sitesChina
- Study dates
- 18 Apr 2025to 1 Apr 2026
- 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 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.
Who cannot join
- 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.
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- 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;
Trial locations and contacts
60 sites in 1 country.
60 sites in 1 country
China60 sites
Inner Mongolia Baogang Hospital
Baotou
Beijing Friendship Hospital, Capital Medical University
Beijing
Beijing Tongren Hospital, Capital Medical University
Beijing
Beijing Tsinghua Changgung Hospital
Beijing
Peking University People's Hospital
Beijing
Cangzhou People's Hospital
Cangzhou
The Second Hospital of Jilin University
Changchun
Changde First People's Hospital
Changde
Third Xiangya Hospital of Central South University
Changsha
The Second People's Hospital of Changzhi
Changzhi
Affiliated Hospital of Chengde Medical College
Chengde
Chengdu Second People's Hospital
Chengdu
Sichuan Provincial People's Hospital
Chengdu
First Affiliated Hospital of Chongqing Medical University
Chongqing
Second Affiliated Hospital of Chongqing Medical University
Chongqing
Dalian Dermatology Hospital
Dalian
Dermatology Hospital, Southern Medical University
Guangzhou
Guangzhou First People's Hospital
Guangzhou
Zhujiang Hospital of Southern Medical University
Guangzhou
Affiliated Hospital of Guilin Medical University
Guilin
Hainan Fifth People's Hospital
Haikou
Hangzhou First People's Hospital
Hangzhou
Zhejiang Provincial People's Hospital
Hangzhou
The Second Affiliated Hospital of Harbin Medical University
Harbin
Dermatology Hospital, Shandong First Medical University
Jinan
Jinan Central Hospital
Jinan
Shandong Provincial Hospital
Jinan
Jingzhou Central Hospital
Jingmen
The First Affiliated Hospital of Kunming Medical University
Kunming
Lianyungang First People's Hospital
Lianyungang
Liaocheng People's Hospital
Liaocheng
Jiangxi Provincial Dermatology Hospital
Nanchang
Second Affiliated Hospital of Nanchang University
Nanchang
Hospital of Dermatology, Chinese Academy of Medical Sciences
Nanjing
First Affiliated Hospital of Ningbo University
Ningbo
Qingdao Traditional Chinese Medicine Hospital (Hai Ci Hospital)
Qingdao
Qujing First People's Hospital
Qujing
Huashan Hospital, Fudan University
Shanghai
Shanghai Skin Disease Hospital
Shanghai
Affiliated Central Hospital of Shenyang Medical College
Shengyang
Zhongyi Northeast International Hospital Co., Ltd.
Shengyang
Liaoning Provincial People's Hospital
Shenyang
Shenyang Hospital of Integrated Traditional Chinese and Western Medicine
Shenyang
Shenzhen Second People's Hospital
Shenzhen
The First Hospital of Hebei Medical University
Shijiazhuang
Shiyan People's Hospital
Shiyan
Suining Central Hospital
Suining
First Hospital of Shanxi Medical University
Taiyuan
Affiliated Hospital of Tianjin Academy of Traditional Chinese Medicine
Tianjin
Meihekou Central Hospital
Tonghua
First Affiliated Hospital of Wenzhou Medical University
Wenzhou
Wuhan No.1 hospital
Wuhan
Second Affiliated Hospital of Wannan Medical College
Wuhu
Affiliated Hospital of Jiangsu University
Wuxi
Wuxi Second People's Hospital
Wuxi
Xingtai People's Hospital
Xingtai
The Affiliated Hospital of Xuzhou Medical University
Xuzhou
Yancheng First People's Hospital
Yancheng
General Hospital of Ningxia Medical University
Yinchuan
Affiliated Hospital of Zunyi Medical University
Zunyi
About this study
Official title: 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.
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.
Read more
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.
Read the detailed description
This is a multicenter, randomized, double-blind, double-dummy, active parallel-controlled Phase III clinical trial evaluating the efficacy and safety of oral HPP737 in adult patients with moderate-to-severe chronic plaque psoriasis. The study is sponsored by Newsoara Biopharma Co., Ltd. (Shanghai) and has been approved by the National Medical Products Administration (NMPA) .
HPP737 is a novel, potent, and selective oral phosphodiesterase type 4 (PDE4) inhibitor in development for the treatment of psoriasis. PDE4 is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases the production of anti-inflammatory mediators, making it a validated therapeutic target for inflammatory diseases such as psoriasis. Preclinical and early clinical data indicate that HPP737 has demonstrated potent inhibition of interleukin-23 (IL-23) and tumor necrosis factor-alpha (TNF-α) production. HPP737 is designed to preferentially inhibit PDE4B, which is associated with anti-inflammatory activity, while limiting PDE4D engagement, which is believed to drive dose-limiting side effects, such as gastrointestinal distress. In Phase I studies, HPP737 was generally well-tolerated with a favorable safety profile.
Study Design: This study consists of three periods: a Screening Period, a Treatment Period, and a Safety Follow-up Period.
Screening Period (Day -14 to Day -1): Potential participants undergo screening procedures to assess eligibility based on inclusion and exclusion criteria.
Treatment Period (Week 0 to Week 16): Eligible participants are randomized in a 2:1 ratio to receive one of the following double-blind, double-dummy treatments for 16 weeks:
HPP737 20 mg orally once daily (experimental group, n≈404) Apremilast (active comparator) orally twice daily according to its approved dosing regimen (active comparator group, n≈202) Safety Follow-up Period (14 days after last dose): Following the completion of the 16-week treatment period, participants enter a safety follow-up period. This follow-up visit occurs 14 days after the last dose of study medication.
Study Population: Approximately 606 participants are planned to be enrolled in China. Eligible participants are adults aged ≥18 years with a confirmed clinical diagnosis of stable moderate-to-severe chronic plaque psoriasis and a history of psoriasis of at least 6 months.
Primary Objectives:
- To evaluate the efficacy of HPP737 20 mg compared with apremilast in patients with moderate-to-severe chronic plaque psoriasis, as measured by the proportion of participants achieving at least of a reduction of 75% in Psoriasis Area and Severity Index (PASI) (PASI 75) at Week 16.
- To evaluate the efficacy of HPP737 20 mg compared with apremilast in patients with moderate-to-severe chronic plaque psoriasis, as measured by the proportion of participants achieving a static Physician's Global Assessment (sPGA) score of "clear" (0) or "almost clear" (1) at Week 16.
The study is conducted in accordance with Good Clinical Practice guidelines and the Declaration of Helsinki. The protocol has been reviewed and approved by the institutional review boards or ethics committees of all participating sites.
- Conditions
- Psoriasis
- Being tested
- HPP737, Placebo matching HPP737, Apremilast, Placebo matching Apremilast
- 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 capsules for oral administration.
Placebo matching HPP737Drug
Also called Placebo
Placebo capsules matching HPP737 for oral administration.
ApremilastDrug
Also called Otezla
Apremilast tablets for oral administration.
Placebo matching ApremilastDrug
Also called Placebo
Placebo tablets matching Apremilast for oral administration.
| Study group | Role | What they receive |
|---|---|---|
| HPP737 20mg | Experimental | Specification:10mg; Participants receive HPP737 20 mg orally once daily for 16 weeks. Receives: Drug: HPP737; Drug: Placebo matching Apremilast |
| Aprmilast 30mg Bid | Active comparator | Participants 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). Receives: Drug: Placebo matching HPP737; Drug: Apremilast |
What is being measured
The primary outcome is the main question the study is designed to answer.
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);
Measured: 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)"
Measured: 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;
Measured: 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;
Measured: 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;
Measured: 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;
Measured: 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;
Measured: From enrollment to end of treatment at 1, 2, 4, 8, 12, and 16 weeks
To evaluate proportion of subjects achieving sPGA (Static Physician's Global Assessment) rating of "clear (score 0) or almost clear (score 1)" at week 1, 2, 4, 8, and 12;
Measured: From enrollment to end of treatment at 1, 2, 4, 8, and 12 weeks
To evaluate change from baseline in Body Surface Area (BSA) score, and percent change from baseline in BSA score at Week 1, 2, 4, 8, 12, and 16;
Measured: From enrollment to end of treatment at 1, 2, 4, 8, 12, and 16 weeks
To evaluate change from baseline in Dermatology Life Quality Index (DLQI) score, and percent change from baseline in DLQI score Week 1, 2, 4, 8, 12, and 16.
Measured: From enrollment to end of treatment at 1, 2, 4, 8, 12, and 16 weeks.
To evaluate incidence and severity of adverse events
Measured: From ICF signed to end of study follow-up at 18 weeks.
To evaluate pharmacokinetic characteristics of subjects at Week 0, Week 4, Week 8, and Week 16
Measured: From enrollment (Week 0) to end of treatment at 4,8,16 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start18 Apr 2025
- Primary completion1 Apr 2026
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 607 participants (actual)
Sponsor and investigators
- Lead sponsor
- Newsoara Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianzhong Zhang, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07712731
- Sponsor's protocol ID
- HPP737-Psoriasis-302
- 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07712731
- Acronym / sponsor ID
- HPP737-Psoriasis-302
- Conditions
- Psoriasis
- Keywords
- Moderate to severe plaque psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 607 participants (actual)
- Lead sponsor
- Newsoara Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Apr 2025 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 17 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a multicenter, randomized, double-blind, double-dummy, active parallel-controlled Phase III clinical trial evaluating the efficacy and safety of oral HPP737 in adult patients with moderate-to-severe chronic plaque psoriasis. The study is sponsored by Newsoara Biopharma Co., Ltd. (Shanghai) and has been approved by the National Medical Products Administration (NMPA) .
HPP737 is a novel, potent, and selective oral phosphodiesterase type 4 (PDE4) inhibitor in development for the treatment of psoriasis. PDE4 is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases the production of anti-inflammatory mediators, making it a validated therapeutic target for inflammatory diseases such as psoriasis. Preclinical and early clinical data indicate that HPP737 has demonstrated potent inhibition of interleukin-23 (IL-23) and tumor necrosis factor-alpha (TNF-α) production. HPP737 is designed to preferentially inhibit PDE4B, which is associated with anti-inflammatory activity, while limiting PDE4D engagement, which is believed to drive dose-limiting side effects, such as gastrointestinal distress. In Phase I studies, HPP737 was generally well-tolerated with a favorable safety profile.
Study Design: This study consists of three periods: a Screening Period, a Treatment Period, and a Safety Follow-up Period.
Screening Period (Day -14 to Day -1): Potential participants undergo screening procedures to assess eligibility based on inclusion and exclusion criteria.
Treatment Period (Week 0 to Week 16): Eligible participants are randomized in a 2:1 ratio to receive one of the following double-blind, double-dummy treatments for 16 weeks:
HPP737 20 mg orally once daily (experimental group, n≈404) Apremilast (active comparator) orally twice daily according to its approved dosing regimen (active comparator group, n≈202) Safety Follow-up Period (14 days after last dose): Following the completion of the 16-week treatment period, participants enter a safety follow-up period. This follow-up visit occurs 14 days after the last dose of study medication.
Study Population: Approximately 606 participants are planned to be enrolled in China. Eligible participants are adults aged ≥18 years with a confirmed clinical diagnosis of stable moderate-to-severe chronic plaque psoriasis and a history of psoriasis of at least 6 months.
Primary Objectives:
- To evaluate the efficacy of HPP737 20 mg compared with apremilast in patients with moderate-to-severe chronic plaque psoriasis, as measured by the proportion of participants achieving at least of a reduction of 75% in Psoriasis Area and Severity Index (PASI) (PASI 75) at Week 16.
- To evaluate the efficacy of HPP737 20 mg compared with apremilast in patients with moderate-to-severe chronic plaque psoriasis, as measured by the proportion of participants achieving a static Physician's Global Assessment (sPGA) score of "clear" (0) or "almost clear" (1) at Week 16.
The study is conducted in accordance with Good Clinical Practice guidelines and the Declaration of Helsinki. The protocol has been reviewed and approved by the institutional review boards or ethics committees of all participating sites.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HPP737 20mg | Experimental | Drug: HPP737, Drug: Placebo matching ApremilastSpecification:10mg; Participants receive HPP737 20 mg orally once daily for 16 weeks. |
| Aprmilast 30mg Bid | Active comparator | Drug: Placebo matching HPP737, Drug: ApremilastParticipants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HPP737HPP737 capsules for oral administration. | Drug | HPP737 20mg |
| Placebo matching HPP737Also: PlaceboPlacebo capsules matching HPP737 for oral administration. | Drug | Aprmilast 30mg Bid |
| ApremilastAlso: OtezlaApremilast tablets for oral administration. | Drug | Aprmilast 30mg Bid |
| Placebo matching ApremilastAlso: PlaceboPlacebo tablets matching Apremilast for oral administration. | Drug | HPP737 20mg |
Primary outcome
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);
Time frame: 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)"
Time frame: From enrollment to end of treatment at 16 weeks
10 secondary outcomes
To evaluate proportion of subjects achieving PASI 75 response at Week 1, 2, 4, 8, and 12;
Time frame: 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;
Time frame: 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;
Time frame: 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;
Time frame: 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;
Time frame: From enrollment to end of treatment at 1, 2, 4, 8, 12, and 16 weeks
To evaluate proportion of subjects achieving sPGA (Static Physician's Global Assessment) rating of "clear (score 0) or almost clear (score 1)" at week 1, 2, 4, 8, and 12;
Time frame: From enrollment to end of treatment at 1, 2, 4, 8, and 12 weeks
To evaluate change from baseline in Body Surface Area (BSA) score, and percent change from baseline in BSA score at Week 1, 2, 4, 8, 12, and 16;
Time frame: From enrollment to end of treatment at 1, 2, 4, 8, 12, and 16 weeks
To evaluate change from baseline in Dermatology Life Quality Index (DLQI) score, and percent change from baseline in DLQI score Week 1, 2, 4, 8, 12, and 16.
Time frame: From enrollment to end of treatment at 1, 2, 4, 8, 12, and 16 weeks.
To evaluate incidence and severity of adverse events
Time frame: From ICF signed to end of study follow-up at 18 weeks.
To evaluate pharmacokinetic characteristics of subjects at Week 0, Week 4, Week 8, and Week 16
Time frame: From enrollment (Week 0) to end of treatment at 4,8,16 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianzhong Zhang principal investigator
Peking University People's Hospital
60 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HPP737 and Apremilast in people with Psoriasis, run by Newsoara Biopharma Co., Ltd. at 60 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 14 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 60 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. 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 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); (time frame: From enrollment to end of treatment at 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.