A Study to Test Whether BI 706321 Combined With Ustekinumab Helps People With Crohn's Disease
Public ClinicalTrials.gov record NCT04978493. 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 IIa, Randomised, Double-blind, Placebo-controlled Trial to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of BI 706321 Orally Administered for 12 Weeks in Patients With Crohn's Disease (CD) Receiving Ustekinumab Induction Treatment
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04978493
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 49 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
- Dec 2, 2021 (Actual)
- Primary completion
- Jul 8, 2024 (Actual)
- Completion
- Aug 8, 2024 (Actual)
- Last update posted
- Sep 4, 2025
2021 – 2024
United States locations
- U.S. sites
- 15
- U.S. states
- 10
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| California Medical Research Associates Inc. | Northridge | California | 91324 | — |
| Sweet Hope Research Specialty Inc | Hialeah | Florida | 33016 | — |
| Nature Coast Clinical Research | Inverness | Florida | 34452 | — |
| I.H.S Health, LLC | Kissimmee | Florida | 34741 | — |
| Advanced Research Institute, Inc. | Orlando | Florida | 32825 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Indiana University | Indianapolis | Indiana | 46202 | — |
| Gastroenterology Associates of Western Michigan | Wyoming | Michigan | 49519 | — |
| BVL Clinical Research | Liberty | Missouri | 64068 | — |
| Carolina Digestive Diseases | Greenville | North Carolina | 27834 | — |
| Houston Methodist Hospital | Houston | Texas | 77030 | — |
| Southern Star Research Institute, LLC | San Antonio | Texas | 78229 | — |
| GI Alliance | Southlake | Texas | 76092 | — |
| University of Utah Health Sciences Center | Salt Lake City | Utah | 84132 | — |
| University of Washington | Seattle | Washington | 98195 | — |
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 34 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04978493, 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 Sep 4, 2025 · Synced Oct 29, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04978493 live on ClinicalTrials.gov.