A Double-Blind, Placebo Controlled, Gluten Challenge Trial of the Efficacy, Safety and Tolerability of 6-weeks Treatment of Latiglutenase (IMGX003) Administration in Patients With Well-Controlled Celiac Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Histologic Protection
研究概览
简要总结
Single Center, Randomized, Double-Blind, Placebo Controlled, Gluten Challenge Trial in Patients with Well-Controlled Celiac Disease
详细描述
This is a phase 2, single-center, prospective, randomized, double-blind, placebo-controlled, study in patients with well-controlled celiac disease. Patients with confirmed CD diagnosis (biopsy) will be recruited to participate in the study. Informed consent must be obtained prior to performing any screening procedures. Patients who meet Visit 1 protocol enrollment criteria will be enrolled and begin the screening period. Patients that fail to meet screening period eligibility will be discontinued from study participation at Visit 2. At Visit 2, eligibility will be confirmed, adverse events will be documented at Visit 2. Patients who continue to meet eligibility requirements at Visit 3 will begin the next treatment phase. During the treatment phase patients will self-administer treatment and gluten daily with their evening meal. At the end of the treatment period, Visit 4, patient eligibility will be confirmed and adverse events will be documented. The final visit, Visit 5, will be a safety follow-up visit.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy confirmed CD diagnosis
- •Self-reported adherence to a gluten-free diet for ≥ 12 months
- •Agree to maintain dosing of approved prescribed and OTC medications
- •Willing to take study treatment with evening meal during any single day
- •Willing to take gluten foodstuff with evening meal during any single day
- •Willing to maintain GFD for entire study duration
- •Willing to agree to minimal ingestion outside of three main daily meals
- •Willing and able to comply with all study procedures
- •Access to the internet via smartphone, tablet, computer or equivalent to facilitate daily symptom reporting
- •Must sign informed consent
排除标准
- •Active dermatitis herpetiformis at the time of screening
- •IBS (Irritable Bowel Syndrome)
- •History of any form of colitis
- •Received any systemic biologics (such as monoclonal antibodies or other protein therapeutics where the half-life overlaps with the study start) within 6 months prior to study start
- •Taking any oral probiotic supplements (not including probiotics contained in commercially available food preparations) 6 months prior to entry
- •Use of any immunosuppressive medications (i.e., for chronic treatment of autoimmune disease or transplant-rejection prophylaxis) 6 months prior to entry
- •History of alcohol abuse, illegal drug use
- •Unwilling to practice highly effective birth control (unless surgically sterilized or post-menopausal)
- •Received any experimental drug within 30 days of randomization, in the case of experimental biologics at least 6 months prior to randomization
- •Uncontrolled complications of celiac disease, which, in the opinion of the investigator, could affect immune response or pose an increased risk to the patient
- •Inability to give informed consent
- •Any medical condition, other than celiac disease, which, in the opinion of the investigator, could adversely affect the patient's participation in the trial.
研究组 & 干预措施
Latiglutenase
IMGX003
干预措施: Latiglutenase (Drug)
Placebo
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Histologic Protection
时间窗: 6 weeks
The primary efficacy endpoint of this study is histologic protection as measured by EGD (Vh:Cd), such that PBO\>Latiglutenase
次要结局
- Symptom Severity(6 weeks)