NL-OMON49704招募中2 期
A Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo-Controlled Study of LY3074828 in Subjects with Active Crohn*s Disease (Serenity) - SERENITY (I6T-MC-AMAG)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Eli Lilly
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Subjects will be eligible for the study only if they meet all of the following criteria within the screening period, which is <=28 days prior to the start of study treatment, unless specifically defined:
- •Type of Subject and Disease Characteristics
- •have had a diagnosis of Crohn*s disease for >=3 months before baseline
- •have active Crohn*s disease as defined absolute SF >=4 (loose and waterystools defined as Bristol Stool Scale Category 6 or 7) and/or AP >=2 at baseline
- •have a SES-CD score >=7 (centrally read) for subjects with ileal-colonic or >=4 for subjects with isolated ileal disease within 14 days before the first dose ofstudy treatment
- •Prior IBD Treatment
- •must have received prior treatment for Crohn*s disease (according to the criteria below):
- •have received treatment with >=1 biologic agents (such as TNF antagonists, vedolizumab, experimental biologic Crohn*s disease therapeutics) with or without documented history of failure to respond to or tolerate suchtreatment:
- •o The treatment must have been discontinued according to the followingtimeline:
- •* anti-TNF therapy at least 8 weeks before baseline
- •* vedolizumab treatment at least 12 weeks before baseline
- •* experimental biologic Crohn*s disease therapy at least 8 weeks beforebaseline.
- •may be receiving a therapeutic dosage of the following drugs:
- •Oral 5-aminosalicylic (ASA) compounds: if the prescribed dose has been stablefor at least 3 weeks before screening colonoscopy or stopped treatment at least 3 weeks prior to screening colonoscopy.
- •Oral corticosteroids must be at a prednisone-equivalent dose of <=20 mg/day, or <=9 mg/day of budesonide, and have been at a stable dose for at least 3 weeks prior to the screening colonoscopy. If stopping oral corticosteroid treatment prior to baseline, they must be stopped at least 3 weeks prior to screening colonoscopy.
- •AZA, 6-MP, or methotrexate (MTX): if the prescribed dose has been stable for at least 4 weeks before screening endoscopy. Subjects who have discontinued therapy with AZA, 6-MP, or MTX must have stopped the medication at least 4 weeks prior to screening endoscopy to be considered eligible for enrollment.
- •Crohn*s disease-specific antibiotics: if the prescribed dose has been stable 4 weeks prior to baseline or stopped treatment at least 3 weeks prior to screening endoscopy.;A complete list of inclusion criteria can be found in the protocol (section 6.1)
排除标准
- •Subjects will be excluded from study enrollment if they meet any of the following criteria within the screening period, which is <=28 days prior to the start of study treatment, unless specifically defined:
- •Study Disease Conditions or Treatments
- •have complications of Crohn*s disease such as strictures, stenoses, or any other manifestation for which surgery might be indicated or could confoundthe evaluation of efficacy
- •diagnosis of conditions affecting the digestive tract, such as UC, indeterminate colitis, fistulizing disease, abdominal or perianal abscess, adenomatous colonic polyps not excised, colonic mucosal dysplasia, and short bowelsyndrome
- •have had any kind of bowel resection, diversion, or placement of a stoma within 6 months or any other intra-abdominal surgery within 3 months prior toscreening
- •have received any of the following for treatment of Crohn*s disease:
- •6-thioguanine (6-TG), cyclosporine, tacrolimus, sirolimus, pentoxifylline, or mycophenolate mofetil within 8 weeks prior to baseline
- •corticosteroid enemas, IV corticosteroids, corticosteroid suppositories, or topical treatment within 3 weeks prior to screening colonoscopy
- •rectal 5-ASA within 3 weeks prior to screening colonoscopy
- •have used apheresis (for example, Adacolumn apheresis) <=2 weeks prior to screening.
- •have previous exposure to any biologic therapy targeting IL-23 p19 eitherlicensed or investigational, or prior exposure to ustekinumab
- •have received natalizumab or agents that deplete B or T cells (for example, rituximab, alemtuzumab, or visilizumab) within 12 months of screening, or, if after receiving these agents, evidence is available at screening of persistentdepletion of the targeted lymphocyte population
- •have been treated with any investigational drug for Crohn*s disease within8 weeks prior to baseline or 5 half-lives of the drug (whichever is longer), OR
- •with interferon therapy within 8 weeks before baseline;A complete list of exclusion criteria can be found in the protocol (section 6.2)
研究者
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