ustekinumab for Crohn's Disease

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Crohn's Diseaseustekinumab - Drug
Eligibility
18 - 75
All Sexes
What conditions do you have?
Select

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

1 of 3

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

2 of 3
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).