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NCT03648541 · ClinicalTrials.gov registry record · Phase 2
BI 655130 Long-term Treatment in Patients With moderate-to Severe Ulcerative Colitis
A Phase 2 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 2
- Development phase
- 79
- Enrollment target
NCT03648541: Completed Phase 2 study, sponsored by Boehringer Ingelheim.
NCT03648541 is a Phase 2 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 79 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03648541, a Phase 2 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 79 participants
- Enrollment target
Study 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
Primary Outcome
Exposure adjusted rate of participants reporting a treatment emergent adverse event (TEAE). The exposure adjusted incidence rate (per 100 subject years) of a selected treatment emergent adverse event is defined as the number of subjects experiencing the adverse event per treatment group during time at risk divided by the total time of subjects at risk in that treatment group to contribute the event to the analysis multiplied by 100 (per 100 subject years). Only participants receiving maintenan
Interventions
- DRUG Spesolimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 79 participants |
| Start Date | 2018-10-29 |
| Est. Completion | 2023-05-03 |
| Phase | Phase 2 |
What the finished NCT03648541 record still lists
NCT03648541 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 79 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% lower).
The record links to 0 conditions, and to 1 intervention - of which Spesolimab is the first listed.
NCT03648541 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03648541 about?
NCT03648541 is a clinical study titled "BI 655130 Long-term Treatment in Patients With moderate-to Severe Ulcerative Colitis". 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, w...
What is the current status of trial NCT03648541?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 79 participants. The study started on 2018-10-29. Estimated completion is 2023-05-03.
What interventions are being tested in trial NCT03648541?
The interventions under investigation include: Spesolimab (DRUG).
Who is sponsoring clinical trial NCT03648541?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03648541's enrollment target sits among peer trials
79 884th of 2000 higher than 1,117 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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