Evaluating the Efficacy and Safety of of HSK44459 in Patients With Behçet's Disease (NCT06902428) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Evaluating the Efficacy and Safety of of HSK44459 in Patients With Behçet's Disease
120 participantsStarted 2025-03-24
Plain-language summary
This is a phase 2, multi-center, randomised, double-blind, placebo-controlled study with an equal randomization among the HSK44459 dose 1, dose 2 and placebo treatment groups. The main objective is to evaluate of the efficacy and the secondary objective is to evaluate the safety and pharmacokinetic.
Who can participate
Age range
18 Years – 75 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
. Male and female subjects aged between 18 and 75 years (inclusive) at the time of signing the informed consent document.
. Diagnosed with Behçet's disease (BD) meeting the International Criteria for Behçet's Disease (ICBD, ICBD-2013) criteria.
. Suffered from at least 3 episodes of oral ulcers within 12 months prior to randomization.
. Had at least 2 oral ulcers present during the Screening Phase.
. Had received drug treatment for Behçet's disease.
. Eligible for systemic treatment of oral ulcers.
. Consented to participate in this trial, and voluntarily signed the informed consent form.
Exclusion criteria
. Active involvement of major organs related to Behçet's disease - pulmonary (eg, pulmonary artery aneurysms), vascular (eg, thrombophlebitis), gastrointestinal (eg, gastrointestinal ulcers), and central nervous system (eg, meningoencephalitis) manifestations, and ocular lesions (eg, uveitis) requiring immunosuppressive treatment.
. Subjects who have received the following immunomodulatory treatments, including:
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.
1Since HSK44459 is being tested in a Phase 2 trial, what does that mean for how much is already known about its safety and effectiveness in people with Behçet's disease — and how does that uncertainty compare to treatments I could get right now?
2The trial is measuring the total burden of oral ulcers over the treatment period rather than just counting them at one point in time — can you help me understand why that matters, and whether that matches what's been bothering me most about my symptoms?
3The trial isn't recruiting yet — do you have a sense of when it might open, and is it worth waiting to see if I qualify, or should we start a standard treatment plan now?
4What is HSK44459 and how does it work differently from the Behçet's treatments you'd normally consider for me — is there a reason this approach might or might not be a good fit for my specific situation?
5If I were to eventually enroll in a study like this, what would participation actually look like day-to-day — things like clinic visits, monitoring, or restrictions — and would that be realistic given my current life and health?
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
Area Under the Curve for the Number of Oral Ulcers From Baseline Through treatment period.