NCT03482635

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

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Colitis, Ulcerative

Interventions

Type	Name	Description
DRUG	Spesolimab	Solution for infusion
DRUG	Placebo	Solution for infusion

Timeline

• Start date: 2018-03-27
• Primary completion: 2020-05-18
• Completion: 2020-05-18
• First posted: 2018-03-29
• Last updated: 2025-10-16
• Results posted: 2021-06-11

Locations

54 sites across 12 countries: United States, Austria, Belgium, Canada, Germany, Italy, Japan, Poland, Russia, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study