Study Summary
This trial is testing a new medication, BI 706321, to see if it helps adults with Crohn's disease, in combination with ustekinumab. Participants will take the medication daily for 3 months, then receive ustekinumab injections every 2 months for 9 months.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 7 Secondary · Reporting Duration: Up to 104 days
At week 12
Absolute change from baseline in Simple Endoscopic Score for Crohn's disease (SES-CD) at week 12
Clinical response
Percent change in Simple Endoscopic Score for Crohn's disease (SES-CD) from baseline at Week 12
At week 48
Biological remission
Clinical remission
Endoscopic remission
Endoscopic response
Up to 104 days
Number of patients with treatment-emergent adverse event (TEAE) through end of treatment (EoT) and the REP period
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
2 Treatment Groups
BI 706321 + ustekinumab
1 of 2
Placebo + ustekinumab
1 of 2
Experimental Treatment
Non-Treatment Group
50 Total Participants · 2 Treatment Groups
Primary Treatment: ustekinumab · Has Placebo Group · Phase 2
BI 706321 + ustekinumabExperimental Group · 2 Interventions: ustekinumab, BI 706321 · Intervention Types: Drug, Drug
Placebo + ustekinumabPlaceboComparator Group · 2 Interventions: ustekinumab, Placebo · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ustekinumab
FDA approved
BI 706321
2021
Completed Phase 1
~80
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 104 days
Who is running the clinical trial?
Boehringer IngelheimLead Sponsor
2,385 Previous Clinical Trials
9,803,899 Total Patients Enrolled
Eligibility Criteria
Age 18 - 75 · All Participants · 8 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have active Crohn's disease.
You have been diagnosed with Crohn Disease (CD) for at least 3 months prior to visit 1, as confirmed at any time in the past by endoscopy and/or radiology, and supported by histology.
You are a woman of childbearing potential.
You have a SES-CD score ≥ 7 (for patients with isolated ileitis ≥4).
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Conditions
Cancer Related
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