EUCTR2020-004767-77-DE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), vaccination with live attenuated vaccines 90 days prior to treatment, during the study, and for 60 days after end of treatment
- •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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