Status:
NOT_YET_RECRUITING
Evaluating the Efficacy and Safety of of HSK44459 in Patients With Behçet's Disease
Lead Sponsor:
Haisco Pharmaceutical Group Co., Ltd.
Conditions:
Behcet's Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 24 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 3 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06902428
Start Date
March 24 2025
End Date
July 3 2026
Last Update
March 30 2025
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