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

NCT03648541 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2025-10-17

Study results available
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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

DRUG

Spesolimab

Solution

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-29
Primary Completion
2023-05-03
Completion
2023-05-03
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Belgium
  • Canada
  • Germany
  • Italy
  • Japan
  • Poland
  • Russia
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03648541 on ClinicalTrials.gov