ClinicalTrials.gov record NCT06902428
Evaluating the Efficacy and Safety of of HSK44459 in Patients With Behçet's Disease
A Multi-center, Randomised, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of HSK44459 Tablets in Patients With Behçet's Disease
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This phase 2, randomized, double-blind, placebo-controlled study will compare two doses of HSK44459 with placebo in about 120 people with Behçet's disease who have oral ulcers. Study treatment is oral tablets taken twice daily for 12 weeks, following a screening period of up to 6 weeks and followed by a 4-week safety follow-up. The study measures oral‑ulcer counts over 12 weeks and collects safety and drug-level (pharmacokinetic) data.
What it is studying. The study tests HSK44459 tablets versus placebo to see how they affect oral and genital ulcers and overall disease activity in Behçet's disease, while also measuring safety and the drug's pharmacokinetics.
What the researchers hope to learn. To evaluate the efficacy of HSK44459 on oral-ulcer burden (primary measure: oral-ulcer counts over 12 weeks), to assess complete response rates for oral and genital ulcers, to measure changes in ulcer pain, disease activity scores, and quality of life, to record adverse events, and to characterize pharmacokinetic parameters (Cmax, elimination half-life, AUC).
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Drug
- HSK44459
- Placebo
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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:
- Hydroxychloroquine was used within 5 days prior to randomization;
- Colchicine was used within 7 days prior to randomization;
- Azathioprine, mycophenolate mofetil, baricitinib, or tofacitinib was used within 10 days prior to randomization;
- Cyclosporine, methotrexate, cyclophosphamide, thalidomide, or dapsone was used within 4 weeks (28 days) prior to randomization;
- Biological agents were used within 5 half-lives prior to randomization;
- Subjects who have received systemic corticosteroid treatment prior to randomization;
- Subjects who have used traditional Chinese patent medicines with immunomodulatory effects within 2 weeks prior to randomization; those who have taken traditional Chinese patent medicines that may affect the efficacy within 2 weeks prior to randomization;
- Patients who have previously received systemic treatment with phosphodiesterase 4 (PDE4) inhibitors;
- Patients who have used a strong CYP3A4 inhibitor or inducer within 14 days prior to randomization or within 5 pharmacokinetic half-lives (whichever is longer); and patients who insist on taking a strong CYP3A4 inhibitor or inducer during the study period;
- Subjects who have used any investigational medicinal product within 4 weeks prior to randomization or within 5 pharmacokinetic half-lives (whichever is longer);
- Laboratory tests during the screening period:
- Hemoglobin ≤ 90g/L;
- White blood cell count < 3.0×10⁹/L or white blood cell count > 14×10⁹/L;
- Platelets < 100×10⁹/L;
- Estimated Glomerular Filtration Rate (eGFR) ≤ 45 ml/min/1.73 m²;
- Total bilirubin > 1.5×ULN;
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) are both > 1.5×ULN;
- Subjects with clinically significant abnormalities in chest X-ray or CT examination at the time of screening, and as judged by the investigator, may place the subject at safety risk;
- Subjects with a history of active or recurrent bacterial, viral, fungal, mycobacterial, or other infections (including but not limited to tuberculosis and atypical mycobacteriosis, hepatitis B and C, and herpes zoster, but excluding onychomycosis) at the time of screening, or any episode of severe infection within 4 weeks prior to screening that required hospitalization or treatment with intravenous or oral antibiotics;
- Subjects with other autoimmune diseases or immune-related chronic inflammatory diseases at the time of screening, such as rheumatic fever, rheumatoid arthritis, systemic lupus erythematosus, etc.;
- Subjects who have undergone or plan to undergo major surgery (evaluated as major surgery by the investigator) within 3 months prior to screening or during the study period;
- Subjects whose blood pressure was still not controlled after treatment with antihypertensive drugs within 3 months prior to screening, and whose blood pressure was ≥ 160/100 mmHg during the screening period;
- Subjects who had a thromboembolic event (including stroke and transient ischemic attack) within 6 months prior to screening;
- Subjects who had any clinically significant heart disease (such as but not limited to unstable ischemic heart disease, NYHA class III/IV left ventricular failure, or myocardial infarction) discovered within 6 months prior to screening or those with clinically significant 12-lead electrocardiogram abnormalities, and as judged by the investigator, may place the subject at safety risk or may interfere with the study evaluation;
- Subjects with a history of attempted suicide within 2 years prior to screening, or a history of major psychiatric illness requiring hospitalization within 3 years prior to screening;
- Subjects with a history of malignant tumor within 5 years prior to screening (except for patients with treated basal cell carcinoma of the skin, in situ squamous cell carcinoma of the skin, or in situ cervical cancer);
- History of gastrointestinal surgery or diseases (excluding appendectomy or simple hernia repair) that may interfere with the pharmacokinetics (PK) of the investigational drug;
- Subjects with active hepatitis B (positive for hepatitis B surface antigen (HBsAg) and hepatitis B virus DNA (HBV-DNA) higher than the upper limit of the normal range), positive for hepatitis C antibody, syphilis infection (positive for anti-TP test), or human immunodeficiency virus (HIV) infection (positive for anti-HIV) during the screening period;
- Subjects with a history of drug abuse, drug use, or excessive alcohol consumption within 3 months prior to screening. Excessive alcohol consumption means an average daily alcohol intake of > 2 units of alcohol;
- Subjects with a history of severe drug allergy or those allergic to the investigational medicinal product specified in the protocol;
- Pregnant and lactating women, or women who plan to become pregnant or breastfeed during the study period;
- Subjects whom the investigator deems to have any other factors that make them unsuitable for participating in this clinical study.
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Detailed description from the registry
This study is a phase 2, multi-center, randomized, double - blind, placebo - controlled study designed to evaluate the efficacy and safety of HSK44459 in the treatment of patients with Behçet Disease (BD). Approximately 120 subjects will be randomized into this study. The entire study will consist of 3 phases: a screening phase, a 12-week treatment phase, and a 4-week follow-up phase. Screening: All subjects will undergo a screening period of up to 6 weeks before the first dose (Visit 3, Day 1). Treatment phase: Eligible BD patients will be randomly assigned to the HSK44459 dose 1 group, the HSK44459 dose 2 group, or the placebo group. During the treatment period, HSK44459 or placebo will be administered twice daily for 12 weeks. Follow-up phase: Subjects in the study (including those who withdraw from treatment for any reason) will have an additional 4 - week follow-up after the end of the last administration.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
After a screening period (up to 6 weeks) to check eligibility, participants are randomized (double‑blind) to take either one of two doses of HSK44459 or matching placebo tablets twice daily for 12 weeks. Study activities include regular clinic visits for safety checks, blood tests (including drug level sampling and routine labs), imaging or chest X‑ray/CT as needed, and completion of questionnaires on symptoms, pain (visual analog scales), disease activity, and quality of life. All participants have a 4‑week safety follow-up after the last dose; adverse events and any new health changes are recorded throughout. Specific participant services or supports are not described in the registry record.
How the study is structured. Interventional Phase 2 trial with equal randomization into three parallel groups (higher dose, lower dose, and placebo). The study is double-blind (participants, investigators, care providers, and outcome assessors are masked). About 120 participants will take study tablets twice daily for 12 weeks; there is a screening period up to 6 weeks and a 4-week post-treatment follow-up.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- Some participants receive a placebo. How is that decided, and what happens for placebo-group participants when the study ends?
- The registry says recruitment has not started. When is it expected to open, and can I register interest now?
- No sites are listed on the registry yet. Where will the study take place?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on Behçet's disease
Important dates
- Study start
- Mar 24, 2025 (estimated)
- Primary completion
- Jun 5, 2026 (estimated)
- Study completion
- Jul 3, 2026 (estimated)
- Target enrollment
- 120 participants (estimated)
- Last updated on registry
- Mar 30, 2025
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Participating sites
Study locations have not been posted on ClinicalTrials.gov yet. This study is not yet recruiting, so sites may be added when recruitment begins.
Terms used on this page · explanations by MedicalUpdates.ai
- randomised
- Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
- double-blind
- Two types of people involved in the study do not know which intervention a participant is receiving. The ClinicalTrials.gov record specifies who is masked, for example participants, care providers, investigators or outcome assessors.
- placebo-controlled
- A study design in which one group receives a placebo so that the study treatment's effects can be compared with no active treatment.
- placebo
- A treatment that looks like the study treatment but contains no active ingredient. Some participants receive it instead of the study treatment, usually without knowing which they got.
- secondary objective
- An additional result the study measures alongside the primary outcome, for example quality of life or a laboratory value.
- pharmacokinetic
- How the body absorbs, distributes, breaks down and removes a drug. It is studied by measuring drug levels or related substances at set times after a dose.
- informed consent
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- immunosuppressive
- A medicine that reduces the activity of the immune system. Studies of autoimmune conditions often require a stable dose, a prior failure, or a washout of such medicines.
- Hydroxychloroquine
- A medicine used for some autoimmune conditions. It appears in eligibility criteria when a study requires or excludes its use.
- 5 half-lives
- The time it takes for the amount of a drug in the body to fall by half. 'Five half-lives' is often used as the point at which a previous drug has essentially left the body.
- corticosteroid
- Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
- investigational
- A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
- screening period
- The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
- Estimated Glomerular Filtration Rate
- A blood-test estimate of how well the kidneys are filtering. Lower numbers mean reduced kidney function; many studies set a minimum value.
- ULN
- The highest value of a blood test that a laboratory considers normal. Criteria such as '≤ 3 × ULN' mean the result must be no more than three times that value.
- CT
- An X-ray scan that builds detailed cross-section images of the body. 'High-resolution' CT (HRCT) is used to look closely at the lungs.
- electrocardiogram
- A recording of the heart's electrical activity. QTc is one measurement from it; some drugs are avoided if it is prolonged.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- follow-up
- The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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