for people ages 18-75 (full criteria)
at San Diego, California and other locations
study started
estimated completion



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.

Official Title

A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI655130 (SPESOLIMAB) Induction Therapy in Patients With Moderate-to-severely Active Ulcerative Colitis Who Have Failed Previous Biologics Therapy


Colitis, Ulcerative Colitis Ulcer Spesolimab


You can join if…

Open to people ages 18-75

  • 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 CAN'T join 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


  • University of California San Diego accepting new patients
    San Diego California 92037 United States
  • University of Utah Health Sciences Center accepting new patients
    Salt Lake City Utah 84132 United States


accepting new patients
Start Date
Completion Date
Boehringer Ingelheim
Phase 2/3
Study Type
Last Updated