NCT03648541

BI 655130 Long-term Treatment in Patients With moderate-to Severe Ulcerative Colitis

An Open Label, Long Term Safety Trial of BI 655130 (SPESOLIMAB) Treatment in Patients With Moderate to Severely Active Ulcerative Colitis Who Have Completed Previous BI 655130 Trials

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the long-term safety of BI 655130 (SPESOLIMAB) in patients with moderate to severely active ulcerative colitis, who have completed treatment in previous trials To evaluate the long-term efficacy of BI 655130 (SPESOLIMAB) in patients with moderate to severely active ulcerative colitis, who have completed treatment in previous trials

Conditions

• Colitis, Ulcerative

Interventions

Type	Name	Description
DRUG	Spesolimab	Solution

Timeline

• Start date: 2018-10-29
• Primary completion: 2023-05-03
• Completion: 2023-05-03
• First posted: 2018-08-27
• Last updated: 2025-10-20
• Results posted: 2024-07-03

Locations

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

Regulatory

• FDA-regulated drug study