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

Purpose

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.

Condition

  • Colitis, Ulcerative

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Group 1- Placebo Group
  • Drug: Placebo
    Solution for infusion
Experimental
Group 2- Small Dose Group
  • Drug: Spesolimab
    Solution for infusion
Experimental
Group 3- Medium Dose Group
  • Drug: Spesolimab
    Solution for infusion
Experimental
Group 4 - High Dose Group
  • Drug: Spesolimab
    Solution for infusion

More Details

Status
Completed
Sponsor
Boehringer Ingelheim

Study Contact