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PsoriasisPhase 2NCT07707141

Safety and Efficacy of HPP737 in Adult Patients With Plaque Psoriasis

A Phase 2 study testing HPP737 20mg in people with Psoriasis, run by Newsoara Biopharma Co., Ltd. at 8 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 placebo, as measured by the proportion of… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Psoriasis
What is being tested?
HPP737 20mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
123 participants
Where
8 sitesChina
Study dates
3 Mar 2021to 20 Dec 2021
Phase
Phase 2
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must voluntarily sign informed consent before any study-related procedures are initiated, be able to communicate effectively with the investigator, and be able to understand and comply with the requirements of this trial.
  • Age at the time of signing the informed consent: 18 years ≤ age ≤ 70 years, regardless of gender.
  • A documented history of chronic plaque psoriasis for ≥ 6 months.
  • Moderate-to-severe plaque psoriasis meeting all of the following criteria: a) PASI (Psoriasis Area and Severity Index) score ≥12; and b) PGA (Physician's Global Assessment) score ≥3; and c) BSA (Body Surface Area) score ≥10%.
  • Subjects are considered suitable for systemic therapy and/or phototherapy and/or photochemotherapy for psoriasis by the investigator.
  • Body Mass Index (BMI): 18 kg/m2 ≤ BMI ≤ 35 kg/m2.

Who cannot join

  • At screening, diagnosis of psoriasis is not chronic plaque-type psoriasis (e.g., pustular psoriasis, erythrodermic psoriasis, or guttate psoriasis).
  • Patients with drug-induced psoriasis (triggered by medications such as β-blockers [beta-receptor blocking agents], calcium channel inhibitors [calcium channel blockers], or lithium) are included.
  • Had a serious or systemic infection within 8 weeks before baseline that required intravenous anti-infective treatment or hospitalization due to infection.
  • Presence of other dermatological conditions considered by the investigator to interfere with psoriasis assessment (e.g., skin bacterial, fungal, or viral infections; seborrheic dermatitis).
  • History of inflammatory bowel disease or concurrent other active autoimmune diseases.
  • History or symptoms of malignancy in any organ system within 5 years prior to screening, whether or not treated, and regardless of evidence of recurrence or metastasis.
Show all 13Show fewer
  • Subjects with a history of depression and/or who exhibit suicidal ideation or any suicidal behavior during the screening period and at baseline as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS, Posner K et al, 2011) will be excluded. If a subject answers "Yes" to any item on the C-SSRS questionnaire, or if the investigator clinically determines the subject to be at risk, the subject will be excluded from the study.
  • Donation of blood or blood loss ≥400 mL within 8 weeks prior to baseline and/or planned blood donation during the study period.
  • History of moderate-to-severe heart failure (New York Heart Association [NYHA] functional classification ≥Class 3), cardiovascular or cerebrovascular event, or other severe adverse events within 3 months prior to screening, and the investigator determines that such subjects are not suitable for participation in this clinical study.
  • Any clinical condition that, in the opinion of the investigator, makes the subject unsuitable for participation in this clinical trial.
  • Known allergy to any component or excipient of the investigational product, or hypersensitivity to other biological agents.
  • Concomitant use of any of the following psoriasis treatments/medications: a) Tumor necrosis factor alpha (TNF-α) antagonist: ① Prior use of a single TNF-α antagonist (for example: use of adalimumab or infliximab within 60 days prior to baseline; use of golimumab within 90 days prior to baseline; use of etanercept within 28 days prior to baseline); ② or prior use of two or more TNF-α antagonists before screening. b) History of the use of other biologic agents prior to screening: including but not limited to anti-interleukin 17 (IL-17) agents, anti-IL-17 receptor agents, anti-IL-12/IL-23 class of drugs; c) Phototherapy/photochemotherapy (including psoralen plus ultraviolet A [PUVA] therapy, ultraviolet B [UVB], or systemic therapies [e.g., methotrexate, cyclosporine, cyclophosphamide, etc.]) within 4 weeks prior to baseline; d) Within 2 weeks prior to baseline, subjects received topical treatment for psoriasis, such as medium to high-potency corticosteroids, vitamin D3 derivatives, or retinoids; however, the following topical treatments are permitted: low-potency corticosteroids (potency classes 6-7), non-medicated shampoos (i.e., those not containing corticosteroids, vitamin D3 derivatives, calcineurin inhibitors, etc.), and emollients without α- or β-hydroxy acids. Received traditional Chinese medicine (TCM) therapy for psoriasis within 2 weeks before baseline.
  • Use of oral or injectable glucocorticoids within 2 weeks before baseline.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

China8 sites

  • Beijing Friendship Hospital, Capital Medical University

    Beijing

  • Beijing Tsinghua Changgung Hospital

    Beijing

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou

  • Shandong Provincial Hospital for Skin Diseases, Shandong First Medical University

    Jinan

  • The First People's Hospital of Lianyungang

    Lianyungang

  • Hospital of Dermatology, Chinese Academy of Medical Sciences

    Nanjing

  • Hong Kong University Shenzhen Hospital

    Shenzhen

  • Wuxi No.2 People's Hospital

    Wuxi

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Safety and Efficacy 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 placebo, as measured by the proportion of patients achieving at least a 75% improvement in the Psoriasis Area and Severity Index (PASI 75) at Day 85? 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

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 (PASI, Physician's Global Assessment (PGA), and Body Surface Area ( BSA)) This is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical trial. Eligible participants are adults aged 18 to 70 years with chronic plaque psoriasis for at least 6 months and moderate-to-severe disease at screening.

Conditions
Psoriasis
Being tested
HPP737 6mg and placebo, HPP737 10mg and placebo, HPP737 20mg, HPP737 placebo
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.

  • HPP737 6mg and placeboDrug

    Also called Prifemilast

    Specification: 1 mg/capsule, 5 mg/capsule; Dosage and administration: 4 capsules (including 1 mg HPP737 drug × 1 capsule, 5 mg HPP737 × 1 capsule, 2 placebo capsules), oral use, once daily for 85 consecutive days.

  • HPP737 10mg and placeboDrug

    Also called Prifemilast

    Specification: 1 mg/capsule, 5 mg/capsule; Dosage and administration: 4 capsules (including 5 mg HPP737 × 2 capsule, 2 placebo capsules), oral use, once daily for 85 consecutive days.

  • HPP737 20mgDrug

    Also called Prifemilast

    Specification: 1 mg/capsule, 5 mg/capsule; Dosage and administration: 4 capsules (including 5 mg HPP737 ×4 capsules), oral use, once daily for 85 consecutive days.

  • HPP737 placeboDrug

    Also called Prifemilast

    Specification: 1 mg/capsule, 5 mg/capsule; Dosage and administration: 4 capsules (including 4 placebo capsules), oral use, once daily for 85 consecutive days.

Study groups in NCT07707141
Study groupRoleWhat they receive
HPP737 6 mgExperimentalNot described
Receives: Drug: HPP737 6mg and placebo
HPP737 10 mgExperimentalNot described
Receives: Drug: HPP737 10mg and placebo
HPP737 20 mgExperimentalNot described
Receives: Drug: HPP737 20mg
HPP737 placeboPlacebo comparatorNot described
Receives: Drug: HPP737 placebo

What is being measured

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

  1. Proportion of subjects achieving at least a 75% improvement in the Psoriasis Area and Severity Index (PASI 75 response) from baseline at Day 85.

    Measured: 85 days

Secondary outcomes (2)

  1. Proportion of subjects achieving a PASI 90 response at Day 85.

    Measured: 85 days

  2. Incidence and severity of adverse events

    including evaluate abnormal findings in vital signs, physical examination, electrocardiogram (ECG) and clinical laboratory tests

    Measured: 85 days

Timeline

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

  1. First posted16 Jul 2026
  2. Study start3 Mar 2021
  3. Primary completion20 Dec 2021
  4. Study completion20 Dec 2021

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
123 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07707141
Sponsor's protocol ID
HPP737-Psoriasis-201
Status last verified
Jul 2026
First submitted
6 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 2 study testing HPP737 20mg in people with Psoriasis, run by Newsoara Biopharma Co., Ltd. at 8 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 6 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 8 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Proportion of subjects achieving at least a 75% improvement in the Psoriasis Area and Severity Index (PASI 75 response) from baseline at Day 85. (time frame: 85 days). 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 NCT07707141.

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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