BI655130 (SPESOLIMAB) Induction Treatment in Patients With Moderate-to-severe Ulcerative Colitis

Launched by BOEHRINGER INGELHEIM · Mar 28, 2018

Keywords

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 18 - 75 years, at date of signing informed consent, males or females
• • Diagnosis of ulcerative colitis ≥ 3 months prior to screening by clinical and endoscopic evidence corroborated by a histopathology report
• • Moderate to severe activity (total MCS 6 to 12 with a RBS ≥ 1 AND an SFS ≥ 1 AND mESS ≥ 2 within 7-28 days prior to first dose)
• • Endoscopic activity extending proximal to the rectum (≥ 15 cm from anal verge)
• • Well-documented demonstration of inadequate response or loss of response or have had unacceptable side effects with approved doses of TNFɑ antagonists (infliximab, adalimumab, golimumab) and/or vedolizumab in the past (screening of both TNFɑ antagonists-AND-Vedolizumab failure patients will be capped once 48 randomized patients in Part 1 and 117 randomized patients in Part 2 meet this criterion; patients who have already been screened at the time of the cap will continue to be randomized into the study)
• • Further inclusion criteria apply
• Exclusion Criteria:
• • Evidence of abdominal abscess at screening
• • Evidence of fulminant colitis or toxic megacolon at screening
• • Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine
• • Further exclusion criteria apply