NCT05831176进行中（未招募）2 期
A Phase 2, 2-Part, Open-Label, Single-Arm Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Gastritis With or Without Eosinophilic Duodenitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 22
- 试验地点
- 87
- 主要终点
- Percent change in peak gastric eosinophil count eosinophils/high power field (eos/hpf)
研究概览
简要总结
This study is researching an experimental drug called dupilumab. The study is focused on participants with active eosinophilic gastritis (EoG) with or without eosinophilic duodenitis (EoD). Participants with EoD only are not eligible for enrollment. EoG and EoD are uncommon, persistent, allergic/immune diseases in which eosinophils (a type of white blood cell) gather in large numbers in the stomach and small intestine and cause inflammation and damage.
The aim of the study is to evaluate the effect of dupilumab on relieving EoG (with or without EoD) symptoms and reducing inflammation in the stomach and, if applicable, small intestine in adults and adolescents aged 12 years and older after at least 24 weeks (about 6 months) and up to 52 weeks (1 year) of treatment.
The study is looking at several other research questions, including:
- What side effects may happen from taking the study drug
- How much study drug is in the blood at different times
- Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
详细描述
This study has 2 parts and a 12-week (about 3 months) Follow-up Period for all participants
- Part A is an open-label treatment period lasting up to 24 weeks (up to 6 months). "Open-label" means that you and the study doctors and the staff staff will know that you are taking the study drug
- Part C is an open-label extended treatment period lasting up to 28 weeks (about 7 months). "Extended Treatment Period" means that you will take the study drug for an additional 28 weeks after finishing Part A if you are eligible to take part in this part of the study
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescent participants will only be enrolled at study sites in countries/regions as permitted by local regulatory authorities and ethic committees (ECs)
- •Documented endoscopic biopsy supporting a pathologic diagnosis of Eosinophilic gastritis (EoG) at least 3 months prior to screening
- •Screening endoscopic biopsies with a demonstration of eosinophilic infiltration for a diagnosis of EoG, as defined in the protocol
- •Completed at least 11 of 14 days of EoG/EoD-SQ eDiary data entry in the 2 weeks prior to the baseline visit
- •History (by participant report) of at least 2 episodes of EoG (with or without EoD) symptoms per week in 8 weeks before screening, as defined in the protocol
- •An average TSS of ≥ 20 calculated using data collected via the EoG/EoD-SQ eDiary per week for the 2 weeks prior to baseline. An average severity score of ≥4 (on a scale of 0-10) per week for the 2 weeks prior to baseline for at least 2 of the 6 symptoms, as defined in the protocol.
排除标准
- •Body weight less than 40 kg at screening
- •Prior participation in a dupilumab clinical trial, or past or current treatment with dupilumab
- •Helicobacter pylori infection
- •Any esophageal stricture unable to be passed with a standard, diagnostic, upper endoscope or any critical esophageal stricture that requires dilation at screening
- •History of achalasia, Crohn's disease, eosinophilic colitis, ulcerative colitis, celiac disease, and prior gastric or duodenal surgery, as defined in the protocol
- •Other causes of gastric and, if applicable, duodenal eosinophilia or the following conditions: eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome) or hyper-eosinophilic syndrome
- •History of bleeding disorders, esophageal or gastric varices that, in the opinion of the investigator, would put the participant at undue risk for significant complications from an endoscopy procedure
- •Initiation or change of a food-elimination diet regimen or re-introduction of a previously eliminated food group in the 4 weeks prior to the screening visit. Participants on a food-elimination diet must remain on the same diet throughout the study
- •Planned or anticipated use of any prohibited medications and procedures during the study
- •Planned or anticipated major surgical procedure during the study
- •Receiving tube feeding or parenteral nutritional at screening
- •NOTE: Other Protocol Defined Inclusion / Exclusion Criteria Apply
研究组 & 干预措施
Dupilumab
Experimental
Part A: Treatment Period Part C: Extended Treatment Period
Eligible participants from Part A will enter Part C
干预措施: Dupilumab (Drug)
结局指标
主要结局
Percent change in peak gastric eosinophil count eosinophils/high power field (eos/hpf)
时间窗: Baseline up to 24 Weeks
次要结局
- Percent change in peak duodenal tissue eosinophil count (eos/hpf)(Baseline up to 52 Weeks)
- Absolute change in EoG scores from the EoG Histology Scoring System (EoGHSS)(Baseline up to 52 Weeks)
- Percent change in peak gastric eosinophil count eosinophils/high power field (eos/hpf)(Baseline up to 52 Weeks)
- Proportion of participants achieving a peak gastric eosinophil count of ≤20 eos/hpf(Up to 52 Weeks)
- Proportion of participants achieving a peak gastric eosinophil count of ≤30 eos/hpf(Up to 52 Weeks)
- Proportion of participants achieving both a peak gastric eosinophil count of ≤20 eos/hpf and a peak duodenal eosinophil count of ≤30 eos/hpf(Up to 52 Weeks)
- Proportion of participants achieving a peak duodenal eosinophil count of ≤30 eos/hpf(Up to 52 Weeks)
- Absolute change in the EoG/EoD-SQ Total Symptom Score (TSS)(Baseline up to 52 Weeks)
- Percent change in the EoG/EoD-SQ TSS(Baseline up to 52 Weeks)
- Change in frequency of diarrhea episodes(Baseline up to 52 Weeks)
- Change in frequency of vomiting episodes(Baseline up to 52 Weeks)
- Change in the Normalized Enrichment Scores (NES) for the type 2 inflammation transcriptome signature(Baseline up to 52 Weeks)
- Change in the NES for the type 2 inflammation transcriptome signature(Baseline up to 52 Weeks)
- Change in the NES for the EoG disease (EoG diagnostic panel (EGDP]) transcriptome signature(Baseline up to 52 Weeks)
- Proportion of participants who receive rescue medications or procedures(Up to 52 Weeks)
- Incidence of treatment-emergent adverse events (TEAEs)(Up to 52 Weeks)
- Incidence of treatment-emergent serious adverse events (SAEs)(Up to 52 Weeks)
- Incidence of treatment-emergent adverse events of special interest (AESIs)(Up to 52 Weeks)
- Incidence of TEAEs leading to permanent discontinuation of study treatment(Up to 52 Weeks)
- Incidence of anti-drug antibody (ADA)(Up to 52 Weeks)
- Titer of ADA(Up to 52 Weeks)
- Incidence of neutralizing antibody (NAb) to dupilumab(Up to 52 Weeks)
- Concentrations of functional dupilumab in serum at each assessment time point(Baseline up to 64 Weeks)
研究者
研究点 (87)
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