A Phase IIb Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Ulcerative Colitis (UC) - IM129-005

Bristol-Myers Squibb0 个研究点目标入组 12 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

暂无简介。

•1. Signed Written Consent
•2. Have had ulcerative colitis (UC) for at least 6 months from the time of initial diagnosis.
•3. In the past have failed or intolerant t at least one convential therapy or currently receiveing at least one convential therapy
•*Inadequate response and/or intolerant response
•-Oral aminosalicylates for at least 6 weeks
•- Prednisone * 40 mg/day for at least 2 weeks
•- Immunosuppressants for at least 12 weeks
•- Intravenous hydrocortisone * 400 mg/day for at least 1 week
•- Approved anti-TNF agent for at least 8 weeks.
•*Currently receiving:
•- Oral aminosalicylates for at least 6 weeks
•- Prednisone * 20 mg/day for at least 4 weeks
•- Immunosuppressants for at least 12 weeks.
•4. Mayo score * 6 with an endoscopic subscore of * 2
•5. Drug Stabilization Requirements
•- Oral corticosteroid treatment must have been * 30 mg/day prednisone at a stable dose for at least 2 weeks prior to randomization into the Induction Period
•-Oral aminosalicylates should be at a stable dose for at least 2 weeks prior to randomization into the Induction Period
•- Azathioprine or 6-mercaptopurine should be at a stable dose for at least 8 weeks prior to randomization into the Induction Period
•6. Men and women * 18 years of age
•7. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test

•1. Diagnosis of Crohn*s Disease or Indeterminate Colitis
•2. Diagnosis of ulcerative colitis that is limited to the rectum
•3. Current evidence of fulminant colitis, toxic megacolon or bowel perforation
•4. Current need for colostomy or ileostomy
•5. Previous total or subtotal colectomy or any surgical resection for UC
•6. Surgical bowel resection within 6 months before screening for any reason other than UC
•7. Primary sclerosing cholangitis (PSC)
•8. Current evidence of colonic dysplasia or past evidence of definite colonic dysplasia that has not been definitively treated
•9. 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
•10. Subjects with a history of or current evidence of malignancies
•11. Subjects at risk for active tuberculosis (TB).
•12. Subjects with any serious bacterial infection within the last 3 months
•13. Subject who have received any live vaccines within 3 months of the anticipated first dose of study medication or who will have need of a live vaccine at any time following randomization into the study

发起方

Bristol-Myers Squibb