NL-OMON36532已完成3 期
A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn's Disease - C13011_MLN0002 for patients with Crohn's Disease
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 6
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
- •Inclusion Criteria
- •1. Age 18 to 80.
- •2. Male or female patient who is voluntarily able to give informed consent.
- •3. Female patients who:
- •Are postmenopausal for at least 1 year before screening, OR
- •Are surgically sterile, OR
- •If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form (ICF) through 6 months after the last dose of study drug, OR agree to completely abstain from heterosexual intercourse.
- •Male patients, even if surgically sterilized (ie, status postvasectomy), who:
- •Agree to practice effective barrier contraception during the entire study treatment period and through 6 months after the last dose of study drug, OR
- •Agree to completely abstain from heterosexual intercourse.
- •4. Diagnosis of CD established at least 3 months before enrollment by clinical and endoscopic evidence and corroborated by a histopathology report. Cases of CD established at least 6 months before enrollment for which a histopathology report is not available will be considered based on the weight of the evidence supporting the diagnosis and excluding other potential diagnoses, and must be discussed with the sponsor*s (or designee*s) medical monitor on a case-by-case basis before enrollment.
- •5. Moderately to severely active CD as determined by a CDAI score of 220 to 400 within 7 days before enrollment and 1 of the following:
- •a. CRP level > 2.87 mg/L during the Screening period, OR
- •b. Ileocolonoscopy with photographic documentation of a minimum of 3 nonanastomotic ulcerations (each > 0.5 cm in diameter) or 10 aphthous ulcerations (involving a minimum of 10 contiguous cm of intestine) consistent with CD, within 4 months before enrollment, OR
- •c. Fecal calprotectin > 250 ug/g stool during the Screening period in conjunction with computed tomography (CT) enterography, magnetic resonance (MR) enterography, contrast-enhanced small bowel radiography, or wireless capsule endoscopy revealing Crohn*s ulcerations (aphthae not sufficient), within 4 months before screening. (Patients with evidence of fixed stenosis or small bowel stenosis with prestenotic dilation should not be included.)
- •6. CD involvement of the ileum and/or colon, at a minimum.
- •7. Patients with extensive colitis or pancolitis of > 8 years duration or limited colitis of > 12 years duration must have documented evidence that a surveillance colonoscopy was performed within 12 months before enrollment (may be performed during screening).
- •8. Patients with a family history of colorectal cancer, personal history of increased colorectal cancer risk, age > 50 years, or other known risk factor must be up-to-date on colorectal cancer surveillance (may be performed during screening).
- •9. Demonstrated, over the previous 5-year period, an inadequate response to, loss of response to, or intolerance of at least 1of the following agents as defined below:
- •Immunomodulators
- •o Signs and symptoms of persistently active disease despite a history of at least one 8-week regimen of oral azathioprine (>= 1.5 mg/kg) or 6 MP (>= 0.75 mg/kg), OR
- •o Signs and symptoms of persistently active disease despite a history of at least one 8-week regimen of methotrexate (>= 12.5 mg/week), OR
- •o History of intolerance of at least 1 immunomodulator (including, but not limited to, nausea/vomiting, abdominal pain, pancreatitis, liver function test
排除标准
- •Exclusion Criteria
- •Gastrointestinal Exclusion Criteria
- •1. Evidence of abdominal abscess during screening
- •2. Extensive colonic resection or subtotal or total colectomy
- •3. History of > 3 small bowel resections or diagnosis of short bowel syndrome
- •4. Have received tube feeding, defined formula diets, or parenteral alimentation within 21 days before enrollment
- •5. Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine
- •6. Within 30 days before enrollment, have received any of the following for the treatment of underlying disease:
- •a. Nonbiologic therapies (eg, cyclosporine, thalidomide) other than those specifically listed in Section 6.2.1 of the full protocol
- •b. A nonbiologic investigational therapy
- •c. An approved nonbiologic therapy in an investigational protocol
- •d. Adalimumab
- •7. Within 60 days before enrollment, have received any of the following:
- •a. Infliximab
- •b. Certolizumab pegol
- •c. Any other investigational or approved biological agent, other than local administration for non-IBD conditions (eg, intra-ocular injections)
- •8. Any prior exposure to natalizumab, efalizumab, or rituximab
- •9. Use of topical (rectal) treatment with 5-ASA or corticosteroid enemas/suppositories within 2 weeks before enrollment
- •10. Evidence of or treatment for C. difficile infection or other intestinal pathogen within 28 days before enrollment
- •11. Currently require or are anticipated to require major surgical intervention for CD (eg, bowel resection) during the study. (Minor surgical procedures to treat complications of CD [eg, fistulotomy] are acceptable.)
- •12. History or evidence of adenomatous colonic polyps that have not been removed
- •13. History or evidence of colonic mucosal dysplasia
- •14. Diagnosis of ulcerative colitis or indeterminate colitis
- •Infectious Disease Exclusion Criteria
- •1. Chronic hepatitis B or C infection
- •2. Active or latent tuberculosis, regardless of treatment history, as evidenced by any of the following:
- •a. History of tuberculosis
- •b. A positive diagnostic TB test defined as:
- •i. A positive QuantiFERON* test or 2 successive indeterminate QuantiFERON* tests within 1 month before enrollment, OR
- •ii. A tuberculin skin test reaction > 10 mm ( > 5 mm in patients receiving the equivalent of > 15 mg/day prednisone) within 3 months before enrollment
- •c. Chest X-ray within 3 months before enrollment in which active or latent pulmonary TB cannot be excluded
- •3. Any identified congenital or acquired immunodeficiency (eg, common variable immunodeficiency, human immunodeficiency virus [HIV] infection, organ transplantation)
- •4. Any live vaccinations within 30 days before enrollment except for the influenza vaccine
- •5. Clinically significant extra-intestinal infection (eg, pneumonia, pyelonephritis) within 30 days before screening or during screening
- •General Exclusion Criteria
- •1. Previous exposure to MLN0002.
- •2. Female patients who are lactating or have a positive serum pregnancy test during the Screening period or a positive urine pregnancy test on Day 1 before enrollment.
- •3. Any unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal, GI, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder that, in the opinion of the investigator, would confound the study results or compromise patient safety.
- •4. Had any surgical procedure requi
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