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

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Colitis, Ulcerative

In brief

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 with moderate-to-severely active ulcerative colitis who have failed previous biologic treatments and to identify efficacious and safe dose regimens in Part 1 (Phase II) * to confirm efficacy and safety of BI655130 (SPESOLIMAB) in patients with moderate-to-severely active ulcerative colitis who have failed previous biologic treatments in Part 2 (Phase III) * To provide, along with induction study 1368-0018 and the run-in cohort of 1368-0020, the target population to be evaluated in study 1368-0020.

Key facts

Study ID

NCT03482635

Run by

Boehringer Ingelheim

People needed

98

Starts

2018-03-27

Expected to finish

2020-05-18

Last updated by the study team

2025-10-16

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Miami — Miami, Florida, United States
• AdventHealth Orlando — Orlando, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Atlanta Center for Gastroenterology, P.C. — Decatur, Georgia, United States
• University of Chicago — Chicago, Illinois, United States
• Columbia University Medical Center-New York Presbyterian Hospital — New York, New York, United States
• University Hospitals of Cleveland — Cleveland, Ohio, United States
• Digestive Disease Specialists Inc — Oklahoma City, Oklahoma, United States
• Baylor College of Medicine — Houston, Texas, United States
• Southern Star Research Institute, LLC — San Antonio, Texas, United States
• Texas Digestive Disease Consultants - Southlake — Southlake, Texas, United States
• Hunter Holmes McGuire VA Medical Center — Richmond, Virginia, United States
• Ordensklinikum Linz GmbH - Barmherzige Schwestern — Linz, Austria
• AKH - Medical University of Vienna — Vienna, Austria
• UZ Leuven — Leuven, Belgium
• Centre Hospitalier Universitaire de Liège — Liège, Belgium
• University of Manitoba - Health Sciences Centre — Winnipeg, Manitoba, Canada
• Victoria Hospital (LHSC) — London, Ontario, Canada
• Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada
• Universitätsklinikum Aachen, AöR — Aachen, Germany
• Universitätsklinikum Erlangen — Erlangen, Germany
• Universitätsklinikum Essen AöR — Essen, Germany
• Klinikum Esslingen GmbH — Esslingen am Neckar, Germany
• Medizinische Hochschule Hannover — Hanover, Germany
• Medical Research Center of Connecticut, LLC — Hamden, Connecticut, United States

Full record on ClinicalTrials.gov

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