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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: Clinical Trial Phase 2 study, sponsored by Boehringer Ingelheim.
NCT04978493 is a Phase 2 study that was terminated before completion, run by Boehringer Ingelheim. The registered enrollment target is 49 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Absolute change from baseline in Simple Endoscopic Score for Crohn's disease (SES-CD) at Week 12 is reported. The SES-CD is a numerical grading system composed of 4 variables (presence of ulcers, ulcerated surface, affected surface, presence of narrowings) recorded sequentially in 5 segments: rectum, left colon, transverse colon, right colon, ileum. Each variable is assigned a value from 0 to 3, and the total score, ranging from 0 to 56, is obtained by adding each variable. Higher values indicat
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 |
Why NCT04978493 stopped before completion
NCT04978493 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04978493 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04978493's enrollment target sits among peer trials
49 1261st of 2000 higher than 736 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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