NCT01809275已完成1 期
A Phase 1/2 Randomized, Placebo-Controlled, Double-Blind Study of the Induction of Clinical Response and Remission by QBECO in Subjects With Moderate to Severe Crohn's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 4
- 主要终点
- Clinical improvement
研究概览
简要总结
The purpose of this study is to evaluate the safety profile and to obtain an indication as to the therapeutic effect of QBECO induction treatment on clinical improvement in moderate to severe Crohn's Disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, 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
- •An adult, age 18 and above
- •Diagnosed with Crohn's disease AT LEAST six (6) months prior to screening
- •Crohn's disease diagnosis was verified by one of these procedures: 1) Colonoscopy 2) Capsule endoscopy 3) Computed Tomography (CT) scan 4) Magnetic Resonance Imaging (MRI) 5) Ultrasound
- •Active Crohn's disease at the time of screening
- •Female participants: Agree to practice two effective methods of contraception, at the same time, from the time of signing the informed consent form, during the entire study treatment and for two (2) months after taking the last dose of study treatment.
- •Male participants: Agree to practice effective barrier contraception during the entire study treatment period and for two (2) months after taking the last dose of study treatment.
排除标准
- •Currently pregnant or breastfeeding
- •Have known or suspected hypersensitivity to any component of the product
- •Had more than three (3) small bowel resections or diagnosis of short bowel syndrome
- •Currently anticipate undergoing any major surgical intervention for Crohn's disease during the next six (6) months
- •Previously been treated with any Qu Biologics' Site Specific Immunomodulators (SSIs) for any disease
- •Diagnosed with chronic (i.e., long term) hepatitis B or C infection
- •Diagnosed with congenital (i.e., existing at or before birth) or acquired immunodeficiency (i.e., lack of body defense system). For example, human immunodeficiency virus (HIV) infection, organ transplantation (i.e., specifically received an organ from a donor), etc.
- •Daily use of narcotic drugs containing opiates (such as morphine, codeine, etc.) for pain control
- •Have a current or recent history (within the past 12 months) of alcohol dependence or illicit drug use, with the exception of medicinal marijuana prescribed by a physician
- •Have a history of cancer within the last five (5) years. Exceptions may apply for cervical cancer and some forms of skin cancer
研究组 & 干预措施
QBECO
Experimental
Individualized maintenance dose ranging from 0.01 - 0.2 mL, administered subcutaneously, every other day for a maximum of 16 weeks
干预措施: QBECO (Drug)
Placebo
Placebo Comparator
Individualized maintenance dose ranging from 0.01 - 0.2 mL, administered subcutaneously, every other day for a maximum of 16 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Clinical improvement
时间窗: 8 weeks
Assessing the change in Crohn's Disease Activity Index (CDAI) from baseline
Safety
时间窗: 8 weeks
Assessing adverse events, concomitant therapies, clinical chemistry, hematology, urinalysis chemistry
次要结局
- Intestinal inflammation(8 weeks)
- Systemic inflammation(8 weeks)
- Clinical remission(8 weeks)
- Clinical response(8 weeks)
研究者
研究点 (4)
Loading locations...
相似试验
终止
2 期
Randomized, Controlled Trial of Extended-Release Niacin (Niaspan®) to Augment Subacute Ischemic Stroke RecoveryIschemic StrokeNCT00796887Henry Ford Health System27
已完成
2 期
Efficacy and Safety Study of MP-513 in Patients With Type 2 DiabetesType 2 DiabetesNCT00628212Tanabe Pharma Corporation324
已完成
2 期
Proof of Concept and Dose-ranging Study of INDV-2000 in Individuals With Moderate to Severe Opioid Use DisorderOpioid Use DisorderNCT06384157Indivior Inc.300
已完成
1 期
A Study of CNTO 3157 in Healthy Normal and Asthmatic Participants Inoculated With Human Rhinovirus Type 16Healthy Volunteers and AsthmaNCT01704040Janssen Research & Development, LLC76
已完成
2 期
A Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Participants With Moderate to Severe Ulcerative ColitisColitis, UlcerativeNCT04613518Bristol-Myers Squibb38