A Phase 2 Randomized, Double-blind, Placebo-controlled Study in HLA-DQ2.5+ Adults With Celiac Disease to Assess the Effect of Nexvax2 on Symptoms After Masked Gluten Food Challenge
试验速览
- 阶段
- 2 期
- 入组人数
- 146
- 试验地点
- 80
- 主要终点
- Efficacy of Nexvax2 compared to placebo in reducing Celiac Disease (CeD) associated GI symptoms.
研究概览
简要总结
A randomized, double-blind, placebo-controlled clinical study in human leukocyte antigen (HLA)-DQ 2.5+ adults with celiac disease (CeD).
详细描述
A phase 2, randomized, double-blind, placebo-controlled clinical study of Nexvax2, in adults subjects with confirmed CeD who have been following a gluten free diet for at least 12 consecutive months prior to screening. This study will evaluate efficacy of Nexvax2 administered subcutaneously. The study plan consists of 3 periods: a screening period of 6 weeks, an approximately 16 week treatment period, and a 4 week post-treatment observational follow-up.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 18 to 70 years of age (inclusive)
- •History of medically diagnosed celiac disease (CeD) that included duodenal biopsy
- •Maintenance of gluten free diet (GFD) for at least 12 consecutive months prior to screening.
- •Willingness to consume a moderate amount of gluten
- •Able to read and understand English
- •Worsening of GI symptoms in response to an oral gluten challenge
- •HLA DQ 2.5 positive
排除标准
- •Unwilling or unable to perform self-injections
- •History of inflammatory bowel disease and/or microscopic colitis.
- •Any medical condition or lab abnormality that in the opinion of the investigator may interfere with study conduct or would impact the immune response (other than CeD), confound interpretation of study results, or pose an increased risk to the subject.
- •Use of immunomodulatory or immune-suppressing medical treatment during the 6 months prior to screening
- •Use of oral or parenteral immunomodulatory corticosteroids, within the 6 weeks prior to screening. Topical or inhaled corticosteroids are acceptable.
- •Receipt of any investigational drug or participation in another clinical study within 6 months prior to screening.
- •Females who are lactating or pregnant
- •Receipt of any vaccine within 1 week prior to planned first day of the treatment period.
研究组 & 干预措施
Nexvax2
干预措施: Nexvax2 (Biological)
Placebo
干预措施: Placebo (Biological)
结局指标
主要结局
Efficacy of Nexvax2 compared to placebo in reducing Celiac Disease (CeD) associated GI symptoms.
时间窗: 79 to 93 days after baseline
Measured by the CeD Patient Reported Outcome (CeD PRO) between baseline and day of the first masked food challenge (MFC) containing gluten. The CeD PRO captures patient ratings for a number of CeD-associated symptoms, on a 0 to 10 scale, with 0 being absent or no symptoms, and 10 being the most severe symptoms. The Total GI domain score is calculated as an average of summed average and individual symptom scores relevant to the GI tract, to yield a value of 0 to 10.
次要结局
- Evaluate efficacy of Nexvax 2 compared with placebo on immune-system activation after the first MFC containing gluten.(79 to 93 days after baseline)
- Evaluate efficacy of Nexvax2 compared with placebo in reducing CeD associated GI symptom sub-domains.(79 to 93 days after baseline)
- Evaluate efficacy of Nexvax2 compared with placebo in reducing individual GI symptoms.(79 to 93 days after baseline)
- Incidence of Treatment-Emergent Adverse Events (TEAEs) in assessing safety and tolerability of Nexvax2.(Study Duration: 21 weeks)