Status:
COMPLETED
BI655130 (SPESOLIMAB) Induction Treatment in Patients With Moderate-to-severe Ulcerative Colitis
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Colitis, Ulcerative
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
Brief Summary
This trial has two sequentially enrolling parts with different objectives. The primary objectives of this trial are * to prove the concept of clinical activity of BI655130 (SPESOLIMAB) in patients wi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 18 2020
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT03482635
Start Date
March 27 2018
End Date
May 18 2020
Last Update
October 16 2025
Active Locations (54)
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1
Medical Research Center of Connecticut, LLC
Hamden, Connecticut, United States, 06518
2
University of Miami
Miami, Florida, United States, 33136
3
AdventHealth Orlando
Orlando, Florida, United States, 32803
4
Emory University
Atlanta, Georgia, United States, 30322