Safety and Efficacy of HPP737 in Adult Patients With Plaque Psoriasis (NCT07707141) | Clinical Trial Compass
CompletedPhase 2
Safety and Efficacy of HPP737 in Adult Patients With Plaque Psoriasis
China123 participantsStarted 2021-03-03
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 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.
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.
Who can participate
Age range
18 Years – 70 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 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.
Exclusion Criteria:
* 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 bac…
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
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.