A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of PRV-015 in Adult Patients With Non-Responsive Celiac Disease as an Adjunct to a Gluten-free Diet
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 388
- 试验地点
- 2
- 主要终点
- Absolute Change From Baseline in Celiac Disease Patient-Reported Outcome Abdominal Symptoms Domain Score Through Week 24
研究概览
简要总结
This study will evaluate the efficacy and safety of PRV-015 in adult patients with non-responsive celiac disease (NRCD) who are on a gluten-free diet (GFD).
详细描述
PRV-015-002b is a Phase 2b, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 3 dose regimens of PRV-015 in adult patients with NRCD who are on a GFD.
Eligible subjects include male or female adults, 18 to 70 years of age, with a diagnosis of celiac disease and have followed a GFD for at least 12 consecutive months, yet continue to experience symptoms.
Study drug (1 of the 3 doses of PRV-015 or placebo) will be administered in a double-blind fashion, followed by a safety follow-up period.
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
- •A diagnosis of celiac disease by intestinal biopsy
- •Following a GFD for at least 12 consecutive months
- •Must have detectable (above the lower limit of detection) serum celiac-related antibodies
- •Must have human leukocyte antigen DQ (HLA-DQ) typing consistent with celiac disease (DQ2 and/or DQ8)
- •Subjects must have had at least one of the following symptoms at least once per week during the month before screening: diarrhea, loose stools, abdominal pain, abdominal cramping, bloating, or gas.
- •Body weight between 35 and 120 kg
排除标准
- •Current diagnosis of any severe complication of celiac disease, such as refractory celiac disease type 1 (RCD-I) or RCD-II, enteropathy-associated T-cell lymphoma (EATL), ulcerative jejunitis, or gastrointestinal (GI) perforation
- •Diagnosis of any chronic, active GI disease other than celiac disease
- •Presence of any active infection
- •Selective immunoglobulin A (IgA) deficiency, defined as having undetectable levels of IgA
- •Known or suspected exposure to coronavirus disease 2019 (COVID-19) infection in the 4 weeks before screening
- •Administration of a live vaccine within 14 days prior to randomization and the first administration of study drug
- •History or presence of any clinically significant disease that, in the opinion of the Investigator, may confound the subject's participation and follow-up in the clinical trial or put the subject at unnecessary risk
- •Females who are pregnant or planning to become pregnant during the study period, or who are currently breastfeeding
研究组 & 干预措施
PRV-015 Low Dose
PRV-015 Low Dose, sterile solution for subcutaneous administration
干预措施: PRV-015 (Biological)
PRV-015 Medium Dose
PRV-015 Medium Dose, sterile solution for subcutaneous administration
干预措施: PRV-015 (Biological)
PRV-015 High Dose
PRV-015 High Dose, sterile solution for subcutaneous administration
干预措施: PRV-015 (Biological)
Placebo
Placebo, sterile solution for subcutaneous administration
干预措施: Placebo (Other)
结局指标
主要结局
Absolute Change From Baseline in Celiac Disease Patient-Reported Outcome Abdominal Symptoms Domain Score Through Week 24
时间窗: Baseline (average of Day -7 to Day -1) up to Week 24
The CeD PRO questionnaire was captured daily in the eDiary. The questionnaire included 9 items: abdominal cramping, abdominal pain, bloating, gas, diarrhea, loose stool, nausea, headache and tiredness. Participants were asked to rate their symptom severity on an 11-point scale and scores range from 0 (not experiencing the symptom) to 10 (the worst possible symptom experience). Abdominal Symptoms domain included abdominal cramping, abdominal pain, bloating and gas. Total score for abdominal symptoms domain range from 0 to 40. Higher scores indicated worse outcome. Baseline abdominal symptoms domain score was defined as the average of the daily scores for the last week of the placebo run-in period.
次要结局
- Absolute Change From Baseline in Celiac Disease Patient-Reported Outcome Diarrhea and Loose Stool Domain Score Through Week 24(Baseline (average of Day -7 to Day -1) up to Week 24)
- Absolute Change From Baseline in Celiac Disease Patient-Reported Outcome Total Gastrointestinal (GI) Score Through Week 24(Baseline (average of Day -7 to Day -1) up to Week 24)
- Number of Participants With Potentially Clinically Important Changes in Urinalysis(From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days)
- Absolute Change From Baseline in Intraepithelial Lymphocyte (IEL) Density at Week 24(Baseline to Week 24)
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs) and Treatment-Emergent Adverse Events of Special Interest (AESIs)(From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days)
- Number of Participants With Potentially Clinically Important Changes in Hematology(From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days)
- Number of Participants With Potentially Clinically Important Changes in Clinical Chemistry(From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days)
- Number of Participants With Potentially Clinically Important Changes in Vital Signs and Body Weight(From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days)
- Number of Participants With Anti-PRV-015 Antibodies(Baseline (Day 1) and Weeks 2, 4, 12, 22, 24 and 28)
- Minimum Serum Concentrations (Cmin) of PRV-015(Pre-dose on Day 1 and Weeks 2, 4, 8, 12, 16, 20, 22, 24 and 28)