CompletedPhase 3

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

China515 participantsStarted 2023-04-20

Plain-language 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 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. 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: From enrollment to end of treatment at 16 weeks

Trial details

NCT IDNCT07712705

SponsorNewsoara Biopharma Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-09-29

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