EUCTR2020-002701-26-IT进行中（未招募）1 期
A Phase 2a Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Proof-of-Concept Clinical Study to Evaluate the Safety and Efficacy of JNJ-64304500 as Add-on Therapy to Standard of Care Biologic Therapy with Anti-Tumor Necrosis Factor Alpha or Anti-Interleukin 12/23 in Responder Not Remitter Participants with Active Crohn's Disease - DUET
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Each potential participant must satisfy all of the following criteria to be enrolled in the study:
- •1. male or female, 18 to 65 years old (inclusive).
- •2. have confirmed clinical diagnosis of Crohn's disease or fistulizing Crohn's disease of at least 3 months' duration.
- •3. initiated SOC biologic therapy
- •- Adalimumab (including HUMIRA or an equivalent biosimilar which could include: HULIO, HYRIMOZ, IMRALDI, or AMGEVITA) at maintenance dose of 40 mg SC q2w
- •- Ustekinumab at maintenance dose of 90 mg SC q8w
- •4. have healthcare provider documentation of suboptimal response to SOC biologic therapy with no documented deterioration or clinical remission during current treatment.
- •5. do not have clinically relevant immunogenicity to participant's current SOC biologic therapy at screening.
- •Please refer to protocol for all inclusion criteria.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 63
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 7
排除标准
- •Any potential participant who meets any of the following criteria will be excluded from participating in the study:
- •1. has complications of Crohn's disease that could confound the effect of treatment.
- •2. currently has or is suspected to have abscess
- •3. has had any kind of bowel resection within 6 months or any other intra-abdominal surgery within 3 months before baseline
- •4. has a draining, stoma or ostomy.
- •5. has had a central line within 12 weeks before first dose
- •Please refer to protocol for all the exclusion criteria.
研究者
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