A Phase 2A, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential, Dose-Ascending Study Of CC-220 In Subjects With Chronic Cutaneous Sarcoidosis
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- Celgene
- 主要终点
- Number of participants with adverse events (AEs)
研究概览
简要总结
This study will evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of oral CC-220 in adult subjects with chronic cutaneous sarcoidosis.
详细描述
This is a Phase 2a, multicenter, randomized, double-blind, placebo-controlled, sequential, dose-ascending, safety and tolerability study in subjects with chronic cutaneous sarcoidosis.
Two dose cohorts of CC-220 (Cohort 1: 0.3 mg by mouth (PO) every day (QD) or matching placebo and Cohort 2: 0.6 mg PO QD or matching placebo) will be evaluated using a sequential, dose-ascending design
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females aged ≥ 18 years at the time of consent.
- •Have chronic cutaneous sacrcoidosis (CCS) prior to consent
- •Have active cutaneous sarcoidosis lesion(s) at screening
- •Forced vital capacity of ≥ 45% of predicted normal value at screening.
- •Estimated Glomerular Filtration Rate (eGFR) ≥ 60 mL/min.
- •Females of childbearing potential must have negative pregnancy tests prior to starting study therapy and agree to either commit to true abstinence or use effective contraception.
- •Male subjects must practice true abstinence or agree to use a condom even if he has undergone a successful vasectomy
排除标准
- •Positive tuberculosis test at screening.
- •History of inadequately treated tuberculosis
- •History of Human Immunodeficiency Virus (HIV) and/or Common Variable Immunodeficiency Disease.
- •History of alcohol or drug abuse
- •History or current peripheral neuropathy
- •Current uveitis or any other clinically significant ophthalmological finding
- •Currently require therapy for precapillary pulmonary hypertension.
研究组 & 干预措施
CC-220 0.3mg
CC-220 0.3 mg capsules by mouth (PO) daily for 12 weeks
干预措施: CC-220 0.3 mg Daily (Drug)
CC-220 0.6mg
CC-220 0.6mg capsules by PO daily for 12 weeks
干预措施: CC-220 0.6mg Daily (Drug)
Placebo
Identically matching placebo PO daily for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with adverse events (AEs)
时间窗: Up to 12 weeks
An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health.
次要结局
- Pharmacokinetics- Maximum Plasma Concentration (Cmax) of CC-220 After Single and Multiple Doses(Day 1 and Day 29 at predose, 1, 2, 3, 4, 6, 8, and 24 hours post-dose)
- Improvement in lesion induration(Week 12)
- Pharmacokinetics - Apparent Total Clearance of CC-220 (CL/F) After Single and Multiple Doses(Day 1 and Day 29 at predose, 1, 2, 3, 4, 6, 8, and 24 hours post-dose)
- Pharmacokinetics - Time to Maximum Plasma Concentration (Tmax) After Single and Multiple Doses(Day 1 and Day 29 at predose, 1, 2, 3, 4, 6, 8, and 24 hours post-dose)
- Improvement in sarcoidosis disease markers(Weeks 4, 8, 12)
- Pharmacokinetics - Area Under the Plasma Concentration-time Curve From Time Zero to Infinity After Single and Multiple Doses (AUC0-inf)(Day 1 and Day 29 at predose, 1, 2, 3, 4, 6, 8, and 24 hours post-dose)
- Pharmacokinetics - Terminal Phase Half-life (t1/2) After Single and Multiple Doses(Day 1 and Day 29 at predose, 1, 2, 3, 4, 6, 8, and 24 hours post-dose)
- Improvement in modified Sarcoidosis Activity and Severity Index(Week 4, 8 and 12)
- Pharmacokinetics - Apparent Volume of Distribution (Vz/f) After Single and Multiple Doses(Day 1 and Day 29 at predose, 1, 2, 3, 4, 6, 8, and 24 hours post-dose)
- Pharmacokinetics - Area Under the Plasma Concentration Time Curve From Time Zero to the Last Quantifiable Time Point After Single and Multiple Doses (AUC 0-t)(Day 1 and Day 29 at predose, 1, 2, 3, 4, 6, 8, and 24 hours post-dose)