Colitis, Ulcerative
Conditions
Brief summary
The purpose of this study is to determine whether BMS-936557 is effective in the treatment of moderate to severely active ulcerative colitis in patients who have had insufficient response and/or intolerance to other medical therapy for ulcerative colitis
Interventions
DRUGPlacebo
Normal Saline, Intravenous, 0mg, Once a week for the first two weeks and every other week thereafter, 7 Weeks
DRUGAnti-IP-10 Antibody
Solution for IV administration, Intravenous, 15 mg/kg, Once a week for the first two weeks and every other week thereafter, 7 weeks
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of moderate to severe UC confirmed by endoscopic and histologic evidence * Mayo score ≥6 with an endoscopic subscore of ≥2 * Inadequate response and/or intolerance to one or more conventional therapy (i.e. oral aminosalicylates, immunosuppressants, corticosteroids, and/or TNF antagonist)
Exclusion criteria
* Diagnosis of Crohn's Disease or Indeterminate Colitis * Diagnosis of UC that is limited to the rectum * Evidence of fulminant colitis, toxic megacolon, or bowel perforation * Current need for a colostomy or ileostomy * Previous total or subtotal colectomy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of the subjects with clinical remission (defined as Mayo score ≤ 2 points with no individual subscore > 1 point) of BMS-936557 with that of the placebo | End of Induction [Week 11, Induction Period-78 (IP-78)] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of the subjects with clinical response of BMS-936557 with that of the placebo | IP-78 (Week 11) | Defined as a reduction from baseline in Mayo score ≥3 points and ≥30% and decrease from baseline in rectal bleeding subscore ≥1 point or absolute rectal bleeding subscore ≤1 point |
| Proportion of subjects with mucosal healing (defined as endoscopy subscore of ≤1 point) of BMS-936557 with that of the placebo | IP-78 (Week 11) | — |
| Proportion of subjects reporting Adverse event (AE), Serious adverse events (SAEs), AEs leading to discontinuation, and markedly abnormal laboratory values | IP-78 (Week 11) | — |
| Mean change from baseline at Inflammatory Bowel Disease Questionnaire (IBDQ) of subjects treated with BMS-936557 and placebo | Baseline (IP-1, Week 1) and IP-78 (Week 11) | — |
Countries
Australia, Austria, Belgium, Brazil, Canada, France, Germany, Hungary, Italy, Mexico, Netherlands, Poland, South Africa, United States
Outcome results
None listed