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NCT03482635 · ClinicalTrials.gov registry record · Phase 2
BI655130 (SPESOLIMAB) Induction Treatment in Patients With Moderate-to-severe Ulcerative Colitis
A Phase 2 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 2
- Development phase
- 98
- Enrollment target
NCT03482635 is a Phase 2 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 98 participants.
The verdict
NCT03482635, a Phase 2 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 98 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG Spesolimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2018-03-27 |
| Est. Completion | 2020-05-18 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03482635
The ClinicalTrials.gov registry entry for NCT03482635 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 98 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03482635 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03482635 about?
NCT03482635 is a clinical study titled "BI655130 (SPESOLIMAB) Induction Treatment in Patients With Moderate-to-severe Ulcerative Colitis". 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 t...
What is the current status of trial NCT03482635?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 98 participants. The study started on 2018-03-27. Estimated completion is 2020-05-18.
What interventions are being tested in trial NCT03482635?
The interventions under investigation include: Placebo (DRUG), Spesolimab (DRUG).
Who is sponsoring clinical trial NCT03482635?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
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