NL-OMON37627撤回2 期
A phase IIb, Double Blind, Randomized, placebo- controlled, Double-Dummy, Dose Rangining Study To Evaluate the Clinical Efficacy and Safety of Induction and Maintenance therapy with BMS- 945429 in subjects with Moderate to Severe Crohn's Disease. - IM133-005
Bristol-Myers Squibb0 个研究点目标入组 12 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 12
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) Signed Written Informed Consent
- •a) Subject is willing to participate in the study, able to provide written informed consent, and has signed the informed consent.;2) Target Population
- •a) Subject must have had Crohn*s Disease for at least 3 months from the time of
- •initial diagnosis. Diagnosis of Crohn*s Disease must have been confirmed by
- •radiologic, endoscopic or histologic evidence within the past 12 months.
- •b) Moderate to severe CD as measured by a CDAI score >= 220 and <= 450
- •c) hsCRP >= 5 mg/L or fecal calprotectin > 250 µg/g or evidence of active disease on
- •screening MRE
- •d) Subjects must satisfy at least one of the following criteria:;i) INADEQUATE RESPONDERS:;In the past, had an inadequate response to one or more of the following treatments:
- •Oral prednisone >= 40 mg/day (or equivalent) or budesonide >= 9 mg/day for at least 2 weeks and/or
- •Immunosuppressants (azathioprine >= 2 mg/kg/day or 6-mercaptopurine >= 1.0 mg/kg/day, [or documentation of a therapeutic concentration of 6-thioguanine nucleotide] or methotrexate >= 15 mg/week) for at least 12 weeks and/or
- •An approved anti-TNF agent at an approved labeled dose for at least 8
- •weeks. The study will include a maximum of approximately 50% subjects
- •who have had prior anti-TNF experience. Upon reaching the maximum
- •number of allowed anti-TNF-experienced subjects, subjects who have had
- •prior anti-TNF experience will no longer be allowed to enter the study.;AND/OR;ii) INTOLERANCE:
- •In the past, experienced intolerance to one or more of the above mentioned
- •treatments (e.g., unable to achieve doses or treatment durations because of
- •dose limiting side effects [e.g. leucopenia, psychosis, uncontrolled diabetes,
- •elevated liver enzymes]).;AND/OR;iii) DEPENDENCE;Currently receiving one or more of the following treatments:
- •Oral Prednisone >= 20 mg/day (or equivalent) or budesonide >= 3 mg/day
- •for at least 4 weeks
- •Immunosuppressants [azathioprine >= 2 mg/kg/day or 6-mercaptopurine
- •>= 1.0 mg/kg/day, (or documentation of a therapeutic concentration of
- •6-thioguanine nucleotide)] for at least 12 weeks.
- •Subjects currently receiving and tolerating the above mentioned treatments
- •(with the exception of anti-TNF agents and methotrexate; see section 3.3.2; Item #4)
- •should continue their treatment.
- •e) Drug stabilization requirements (for subjects entering the study on one or more of
- •these medications)
- •i. Oral corticosteroid treatment must have been the equivalent of <= 30 mg
- •prednisone or <= 9 mg budesonide daily at a stable dose for at least 2 weeks
- •prior to entry into the Induction Period (IP-1)
- •ii. Oral aminosalicylates should be at a stable dose for at least 2 weeks prior to
- •entry into the Induction Period (IP-1)
- •iii. Azathioprine, and 6-mercaptopurine should be at a stable dose for at least 8
- •weeks prior to entry into the Induction Period (IP-1)
- •3) Age and Reproductive Status
- •a) Men and women, >= 18 years of age
- •b) Women of childbearing potential (WOCBP) must use highly effective methods of
- •birth control for up to 24 weeks after the last dose of investigational product to
- •minimize the risk of pregnancy. WOCBP must follow instructions for birth
- •control for the entire duration of the study including a minimum of 24 weeks after
- •dosing has been completed. Acceptable methods of highly effective birth c
排除标准
- •Exclusion Criteria
- •1) Target Disease Exceptions
- •a) Current diagnosis of Ulcerative Colitis or Indeterminate Colitis or clinical findings suggestive of Ulcerative Colitis;b) CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic or ileal involvement
- •c) Subjects with history of diverticulitis or intestinal and/or upper GI perforation
- •d) Active intra-abdominal/perianal abscesses or subclinical diverticulitis and intraabdominal
- •or perianal abscesses diagnosed at screening with MRE.
- •e) Known strictures or stenosis (without inflammatory component) leading to symptoms of obstruction
- •f) Current stoma or current need for colostomy or ileostomy.
- •g) Previous total proctocolectomy or subtotal colectomy with ileorectal anastomosis
- •h) Surgical bowel resection within 6 months before screening
- •i) Extensive small bowel resection (> 100 cm) or known short bowel syndrome
- •j) History of primary sclerosing cholangitis (PSC) or diagnosed at screening
- •k) Currently receiving total parenteral nutrition;2) Medical History and Concurrent Diseases
- •a) Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, pulmonary, cardiac, neurological, ophthalmologic or cerebral disease. Concomitant medical conditions that in the opinion of the Investigator might place the subject at unacceptable risk for participation in this study
- •b) Current evidence of colonic dysplasia or past evidence colonic dysplasia that has
- •not been definitively treated
- •c) Have present or previous malignancies, except history of cured squamous or basal
- •skin cell carcinoma or cured breast or cervical cancer for >= 5 years without evidence of recurrence
- •d) Subjects who are scheduled or anticipate the need for surgery, aside from dermatologic procedures
- •e) Subjects with a history of (within 12 months of signing the consent), or known current problems with drug or alcohol abuse or known cirrhosis including alcoholic cirrhosis.
- •f) Concomitant illness that in the opinion of the Investigator, is likely to require parenteral glucocorticosteroid therapy during the study (e.g. moderate to severe asthma)
- •g) Subjects with a clinically significant abnormal chest x-ray at screening;h) Subjects at risk for tuberculosis (TB).
研究者
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