NCT04882007已完成2 期
Randomized, Double-blind, Phase 2 Study to Evaluate the Efficacy and the Safety of OSE-127 Versus Placebo in Subjects With Moderate to Severe Active Ulcerative Colitis Who Have Failed or Are Intolerant to Previous Treatment(s)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 67
- 主要终点
- Change in modified Mayo Score
研究概览
简要总结
This is a phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group study in patients with moderate to severe active ulcerative colitis.
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)
盲法说明
During the Double-blind phase all participants will be blinded to treatment assignment.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent document indicating that the patient has been informed of all the pertinent aspects of the trial prior to enrollment
- •Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
- •Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks after last dose
- •Male or female 18 to 75 years of age, inclusive
- •Diagnosis of moderate to severe active UC made at least 3 months before the screening visit. The diagnosis of UC must have been confirmed by endoscopy, with a minimal extent of 15 cm from anal margin and histology (Moderate to severe active UC is defined by a modified Mayo score between 4 and 9, inclusive. The modified Mayo score is defined by the addition of the rectal bleeding subscore, the stool frequency sub-score, and the endoscopic sub-score. Thus, to be included, a patient must have the following:
- •a rectal bleeding score ≥ 1,
- •a stool frequency score ≥ 1 (sub-score calculated before bowel preparation), and
- •an endoscopic sub-score ≥ 2
- •No previous biologic therapy (i.e., TNF antagonists, vedolizumab or ustekinumab) and prior or current UC documented medication history that includes at least 1 of the following:
- •Corticosteroids
- •Immunosuppressive agents
- •Previous or current biologic therapy
排除标准
- •Stoma, proctocolectomy, or subtotal colectomy
- •Physician judgment that patient is likely to require any surgery for UC during the study duration, or double-blind phase duration at least
- •Evidence of fulminant colitis, toxic megacolon, or perforation
- •Current or recent (within 4 weeks prior to screening) hospitalization for UC care and/or treatment with IV steroids
- •The following laboratory results at screening:
- •Elevation at screening of aminotransferase (AST), alanine aminotransferase (ALT) > 3 × the upper limit of normal (ULN) or total bilirubin > 2 × ULN (unless due to Gilbert's disease) or evidence of chronic liver disease
- •Platelet count < 100,000/mm3
- •Hemoglobin (Hgb) < 8.5 g/dL
- •Neutrophils < 1500/mm3
- •Lymphocytes < 800/mm3
- •Absolute white blood cell (WBC) count < 3000/mm3
- •Crohn's disease or indeterminate colitis or any other diagnosis not consisting with UC
- •History or evidence of incompletely resected colonic dysplasia or unconventional lesion at risk of colonic adenocarcinoma
- •Stool culture or other examination positive for enteric pathogen, including Clostridium difficile (C. diff) toxin. If positive, the patient should be treated and rescreening is allowed.
- •Men or women with childbearing potential not willing to use adequate birth control during the study. Adequate birth control includes surgical sterilization, intrauterine device, oral contraceptive, contraceptive patch, long-acting injectable contraceptive, partner's vasectomy, double-barrier method (condom, diaphragm with spermicide), or abstinence during study and 30 days following the last follow-up visit. Women of childbearing potential will enter the study after a negative pregnancy test.
- •Breastfeeding
- •Chronic use of nonsteroidal anti-inflammatory drugs (NSAIDs) from screening through the end of the study
- •Use of topical steroids and/or topical 5-aminosalicylic acid preparations within 2 weeks before the screening visit (all such medications should be withdrawn at least 2 weeks prior to the screening visit)
- •Use of antidiarrheals within 2 weeks before the screening visit (all such medications should be withdrawn at least 2 weeks prior to the screening visit)
- •Treatment with azathioprine, 6-MP, methotrexate (MTX), cyclosporin, tacrolimus, sirolimus, leflunomide and/or mycophenolate mofetil within 4 weeks before the screening visit (all such medications should be withdrawn at least 4 weeks prior to the screening visit)
研究组 & 干预措施
OSE-127 High dose induction phase
Experimental
OSE-127 mAb antagonist to CD127 receptor (or IL-7Rα) intravenous infusion 3 total infusions, weeks 0, 2, and 6
干预措施: OSE-127 (Drug)
OSE-127 Low dose induction phase
Experimental
OSE-127 mAb antagonist to CD127 receptor (or IL-7Rα) intravenous infusion 3 total infusions, weeks 0, 2, and 6
干预措施: OSE-127 (Drug)
Placebo induction phase
Placebo Comparator
Normal saline intravenous infusion 3 total infusions, weeks 0, 2, and 6
干预措施: Placebo (Drug)
OSE-127 High dose optional extension phase
Experimental
OSE-127 mAb antagonist to CD127 receptor (or IL-7Rα) intravenous infusion 7 total infusions, weeks 10, 14, 18, 22, 26, 30, and 34
干预措施: OSE-127 (Drug)
结局指标
主要结局
Change in modified Mayo Score
时间窗: Baseline and Week 10
Change in modified Mayo Score between baseline and Week 10 clinical symptoms (stool frequency and rectal bleeding sub-scores) additionally to the endoscopic sub-score
次要结局
- Clinical Remission(Week 10)
- Clinical efficacy of OSE-127 vs placebo(Week 10)
- Efficacy of OSE-127 vs placebo on endoscopic remission(Week 10)
- Efficacy of OSE-127 vs placebo on endoscopic improvement(Week 10)
- Overall safety and tolerability of OSE-127 in patients with moderate to severe UC(Week 0 to Week 22 for patients not participating in the optional extension, and Week 0 to Week 50 for patients participating in the optional extension)
研究者
研究点 (67)
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