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NCT04978493 · ClinicalTrials.gov registry record · Phase 2
A Study to Test Whether BI 706321 Combined With Ustekinumab Helps People With Crohn's Disease
A Phase 2 study, sponsored by Boehringer Ingelheim.
- Terminated
- Registry status
- Phase 2
- Development phase
- 49
- Enrollment target
NCT04978493 is a Phase 2 study that was terminated before completion, run by Boehringer Ingelheim. The registered enrollment target is 49 participants.
The verdict
NCT04978493, a Phase 2 study, was terminated before completion, sponsored by Boehringer Ingelheim.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 49 participants
- Enrollment target
Study Summary
This study is open to adults, aged 18-75 years, with moderate to severe Crohn's disease. The purpose of this study is to find out whether BI 706321 combined with ustekinumab helps people with Crohn's disease. BI 706321 is a medicine being developed to treat Crohn's disease. Ustekinumab is a medicine already used to treat Crohn's disease. Participants are put into 2 groups randomly, which means by chance. One group gets BI 706321 and ustekinumab. The other group gets placebo and ustekinumab. Participants take BI 706321 or placebo as tablets every day. Placebo tablets look like BI 706321 tablets but do not contain any medicine. Ustekinumab is given as an infusion into a vein once at the beginning of the study. After that, ustekinumab is given as an injection under the skin every 2 months. Participants take BI 706321 or placebo in combination with ustekinumab for 3 months. After that, participants receive only ustekinumab for another 9 months. Participants are in the study for about 1 year. During this time, they visit the study site about 13 times. At 3 of the visits, doctors do a colonoscopy to examine the bowel. The results from the colonoscopies are compared between the 2 groups. The doctors also regularly check participants' health and take note of any unwanted effects.
Interventions
- DRUG Placebo
- DRUG Ustekinumab
- DRUG BI 706321
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2021-12-02 |
| Est. Completion | 2024-08-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04978493
The ClinicalTrials.gov registry entry for NCT04978493 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 49 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 3 interventions - of which Placebo is the first listed.
NCT04978493 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04978493 about?
NCT04978493 is a clinical study titled "A Study to Test Whether BI 706321 Combined With Ustekinumab Helps People With Crohn's Disease". This study is open to adults, aged 18-75 years, with moderate to severe Crohn's disease. The purpose of this study is to find out whether BI 706321 combined with ustekinumab helps people with Crohn's disease. BI 706321 is a medicine being developed to treat Crohn's disease. Ustekinumab is a medicin...
What is the current status of trial NCT04978493?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 49 participants. The study started on 2021-12-02. Estimated completion is 2024-08-08.
What interventions are being tested in trial NCT04978493?
The interventions under investigation include: Placebo (DRUG), Ustekinumab (DRUG), BI 706321 (DRUG).
Who is sponsoring clinical trial NCT04978493?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
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