EUCTR2020-004767-77-PL进行中（未招募）1 期
A Phase 2, Randomized, Double-blinded, Placebo-controlled, 5 Parallel-group Study of BMS-986166 or Branebrutinib for the Treatment of Patients with Moderate to Severe Atopic Dermatitis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Females or males 18 (or local age of majority)-65 years inclusive
- •Dx of AD of at least 24 months duration
- •Screening EASI = 12 and = 16 at baseline
- •vIGA = 3 at screening and baseline
- •documented history of inadequate control of AD by a stable regimen (= 4 weeks) of topical corticosteroids, calcineurin inhibitors or biologics, within 6 months of randomization or inappropriateness of tx dur to side effects or safety risks.
- •Documentation of positive VZV Ig antibody status or complete VZV vaccination within 90 days of first dosing.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 230
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Any major illness, condition, infection, cancer or hx of cancer or lymphoproliferative disease, including prelymphoma
- •Pregnancy, lactation, or plans for either
- •Clinically relevant cardiovascular or pulmonary conditions (including severe sleep apnea)
- •History of significant ocular disease
- •History of diabetes mellitus Type 1 or uncontrolled diabetes mellitus Type 2 with hemoglobin ALC > 8% or diabetic patients with significant comorbidities like retinopathy or nephropathy
- •History of testicular disease or epididymal disease/disorder except uncomplicated epididymitis successfully treated with antibiotics
- •Serum creatinine and total bilirubin > 2mg/dL
- •eGFR < 60mL/min/1.73 m2
- •ALT/AST > 1.5x ULN
- •Hemoglobin < 10 g/dL
- •Abnormal OCT test suggestive of macular or choroidal pathology
- •Surgery within the past 30 days before first dose or planned surgery during the study
- •History of TB
- •Positive result for Hepatitis B, Hepatitis C, HIV infection
- •History of congenital or acquired immunodeficiency
- •Presence of COVID-19 symptoms, COVID (suspected or confirmed) within 12 weeks of screening, at screening, or on Day 1, known or suspected sequelae of any sort following a prior episode of COVID, COVID vaccination within 14 days of screening (or plans to receive COVID vaccine during the study)
- •High likelihood (based on subject history) of requiring rescue therapy in < 4 weeks of randomization
- •Evidence of acute AD flare between screening and baseline/randomization
- •Treatment with anticoagulant or antiplatelet therapies (including aspirin for cardioprotection within 2 weeks prior to randomization
- •AD-related prescription or OTC skin barrier treatments within 2 weeks of randomization
- •Use of strong or moderate inhibitors or inducers of CYP2C8 or 3A4 within 5 half-lives or 14 days prior to randomization (inhibitors) or within 3 weeks prior to randomization (inducers)
- •Use of systemic immunosuppressive drugs or oral herbal immunomodulatory medications within 8 weeks of randomization
- •IV immunoglobulin within 8 weeks of randomization or during the study
- •Use of biologics within 8 weeks to 6 months (depending on type) prior to randomization
- •Prior exposure to BTK inhibitors or S1PR modulators
- •Use of any immunomodulator or investigational drug within the longer of 5 PK half-lives or 5 PD half-lives or within 6 months prior to randomization
- •WBC < 3000/µL or > 14,000/µL
- •ANC < the lower of either LLN or 1500/µL
- •ALC < 1000/µL
- •Platelet count < 100,000/µL
研究者
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