BI655130 (SPESOLIMAB) Induction Treatment in Patients With Moderate-to-severe Ulcerative Colitis
Public ClinicalTrials.gov record NCT03482635. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03482635
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 98 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 26, 2018
- Primary completion
- May 17, 2020
- Completion
- May 17, 2020
- Last update posted
- Oct 15, 2025
2018 – 2020
United States locations
- U.S. sites
- 13
- U.S. states
- 9
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Medical Research Center of Connecticut, LLC | Hamden | Connecticut | 06518 | — |
| University of Miami | Miami | Florida | 33136 | — |
| AdventHealth Orlando | Orlando | Florida | 32803 | — |
| Emory University | Atlanta | Georgia | 30322 | — |
| Atlanta Center for Gastroenterology, P.C. | Decatur | Georgia | 30033 | — |
| University of Chicago | Chicago | Illinois | 60637 | — |
| Columbia University Medical Center-New York Presbyterian Hospital | New York | New York | 10032 | — |
| University Hospitals of Cleveland | Cleveland | Ohio | 44106 | — |
| Digestive Disease Specialists Inc | Oklahoma City | Oklahoma | 73112 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| Southern Star Research Institute, LLC | San Antonio | Texas | 78229 | — |
| Texas Digestive Disease Consultants - Southlake | Southlake | Texas | 76092 | — |
| Hunter Holmes McGuire VA Medical Center | Richmond | Virginia | 23249 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 41 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03482635, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 15, 2025 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03482635 live on ClinicalTrials.gov.