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)

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 12

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Compare the proportion of the subjects with clinical remission (defined as Mayo<br /><br>score * 2 points with no individual subscore > 1 point) of BMS-936557 with that<br /><br>of the placebo at IP-50 (Week 7).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Compare the proportion of the subjects with clinical response (defined as<br /><br>reduction from baseline in Mayo score * 3 points and * 30%, and decrease from<br /><br>baseline in rectal bleeding subscore * 1 point or absolute rectal bleeding<br /><br>subscore * 1 point) of BMS-936557 with that of the placebo at IP-50 (Week 7)<br /><br>* Compare the proportion of subjects with mucosal healing (defined as endoscopy<br /><br>subscore of * 1 point) of BMS-936557 with that of the placebo at IP-50 (Week<br /><br>7).</p><br>

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