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BI 706321 + Ustekinumab for Crohn's Disease

Phase 2

Recruiting

Research Sponsored by Boehringer Ingelheim

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Symptomatic CD defined as Crohn's Disease Activity Index (CDAI) ≥150.

Presence of mucosal ulcers in at least one segment of the ileum or colon and a Simple Endoscopic Score for Crohn's disease (SES-CD) score ≥ 7 (for patients with isolated ileitis ≥4).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 104 days

Awards & highlights

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.

Who is the study for?

Adults aged 18-75 with moderate to severe Crohn's disease can join this trial. They must have a confirmed diagnosis for at least 3 months, active symptoms, and certain inflammation markers. Stable doses of specific medications are required, and women must use effective birth control. Exclusions include recent surgeries, other IBD diagnoses, untreated abscesses or infections like HIV or COVID-19.Check my eligibility

What is being tested?

The study tests if BI 706321 combined with ustekinumab is beneficial for Crohn's disease treatment compared to ustekinumab alone. Participants will take BI 706321 or placebo tablets daily plus an initial infusion followed by injections of ustekinumab every two months over a year.See study design

What are the potential side effects?

Potential side effects may include reactions related to the immune system due to ustekinumab (like skin reactions), as well as any new side effects from BI 706321 since it's under development. Regular health checks will monitor for unwanted effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My Crohn's disease is active, with a CDAI score of 150 or more.

Select...

I have Crohn's disease with ulcers in my intestines and a high severity score.

Select...

I am on a stable dose of oral corticosteroids for my condition, not exceeding the specified limits.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 104 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 104 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 104 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Absolute change from baseline in Simple Endoscopic Score for Crohn's disease (SES-CD) at week 12

Secondary outcome measures

Biological remission

Clinical remission

Clinical response

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: BI 706321 + ustekinumabExperimental Treatment2 Interventions

Group II: Placebo + ustekinumabPlacebo Group2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BI 706321

2021

Completed Phase 1

~80

ustekinumab

2016

Completed Phase 3

~4290

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor

2,507 Previous Clinical Trials

11,340,524 Total Patients Enrolled

Media Library

BI 706321 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04978493 — Phase 2

Crohn's Disease Research Study Groups: BI 706321 + ustekinumab, Placebo + ustekinumab

Crohn's Disease Clinical Trial 2023: BI 706321 Highlights & Side Effects. Trial Name: NCT04978493 — Phase 2

BI 706321 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04978493 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I qualify to participate in this medical experiment?

"In order to be considered for this project, potential enrollees should have ileocolitis and be between 18-75 years old. Currently, the clinical trial is recruiting approximately 50 participants."

Answered by AI

What other research has been undertaken to further explore the efficacy of ustekinumab?

"Presently, there are 34 active clinical trials researching ustekinumab. Of those studies, 17 have entered the final Phase 3 stage. Most of these investigations are occurring in Gdansk, Pomorskie but 2820 medical centres worldwide carry out experiments for this medication."

Answered by AI

Is there an open call for participants in this research?

"Clinicaltrials.gov reveals that this clinical investigation is actively recruiting volunteers, with the original post date being October 4th 2021 and the most recent update occurring on November 17th 2022."

Answered by AI

Are there any Canadian medical centers conducting this research project?

"Southern Start Research Institute, LLC in San Antonio, Options Health Research in Tulsa and Atlanta Center for Gastroenterology, P.C. in Decatur are just some of the 19 available sites that are partaking in this study."

Answered by AI

Under what conditions is ustekinumab typically prescribed?

"Ustekinumab is generally administered to treat adrenal cortex hormones, but can be employed to manage an inadequate response to one or more tnf antagonist therapies, psoriasis and severe active Crohn´s disease."

Answered by AI

Is there a cap on the number of individuals enrolled in this research?

"The trial's sponsor, Boehringer Ingelheim, must enrol 50 suitable participants from various sites such as Southern Star Research Institute, LLC in San Antonio and Options Health Research in Tulsa."

Answered by AI

Has the Federal Drug Administration given its seal of approval to ustekinumab?

"Despite being in Phase 2, the safety of ustekinumab has been assessed and given a score of 2 on Power's scale. As this is an early stage trial there is still no evidence to support its efficacy."

Answered by AI

Can minors participate in this scientific investigation?

"The parameters of this clinical trial include people aged 18 to 75, but we have 80 trials open for minors and 220 studies that are only available to elderly patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Test Whether BI 706321 Combined With Ustekinumab Helps People With Crohn's Disease

2021. "A Study to Test Whether BI 706321 Combined With Ustekinumab Helps People With Crohn's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04978493.

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