BI 655130 Induction Treatment in Patients With Moderate-to-severe Ulcerative Colitis

  • Interventional
  • Recruiting
  • NCT03482635
Eligibility Details Visit Clinicaltrials.gov

A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 Induction Therapy in Patients With Moderate-to-severely Active Ulcerative Colitis Who Have Failed Previous Biologics Therapy

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 BI 655130 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 BI 655130 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.

Gender
All

Age Group
18 Years to 75 Years

Accepting 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 agonists (infliximab, adalimumab, golimumab) and/or vedolizumab in the past

         - 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

At a Glance

National Government IDNCT03482635

IRB#IRB18-0201

Lead SponsorBoehringer Ingelheim

Lead PhysicianRussell D. Cohen

Collaborator(s)N/A

EligibilityAll
18 Years to 75 Years
Recruiting