What is the mechanism of action of this treatment?

Common treatments for Crohn's Disease, such as the investigational drug BI 706321 and ustekinumab, work by modulating the immune response to reduce inflammation. BI 706321 potentially targets inflammatory pathways, while ustekinumab is a monoclonal antibody that inhibits interleukin-12 (IL-12) and interleukin-23 (IL-23). These cytokines play a key role in the inflammatory process of Crohn's Disease. By targeting these pathways, these treatments aim to decrease inflammation, promote mucosal healing, and maintain remission, which is crucial for improving the quality of life and reducing the need for surgical interventions in Crohn's Disease patients.

What side effects are associated with this type of intervention?

Common treatments for Crohn's Disease, such as ustekinumab, can cause side effects including infections (e.g., nasopharyngitis), headache, and injection site reactions. Serious infections are less common but possible. Investigational drugs like BI 706321, which target inflammatory pathways, may have similar side effects, including risks of infection and immune-related reactions. Combining these treatments could potentially increase the risk of these side effects.

What prior FDA approvals exist?

Ustekinumab, a monoclonal antibody targeting IL-12 and IL-23, has been FDA-approved for the treatment of Crohn's Disease. It is used both for induction and maintenance therapy, showing efficacy in patients who have not responded to anti-TNF therapy. Other related drugs targeting inflammatory pathways include anti-TNF agents like infliximab and adalimumab, and integrin inhibitors like vedolizumab. These treatments aim to reduce inflammation and achieve clinical remission in patients with moderate to severe Crohn's Disease.

What other types of research exist?

Promising novel alternatives for Crohn's Disease treatment in 2024 include anti-IL-23 agents such as Mirikizumab, Risankizumab, Brazikumab, and Guselkumab. These agents have demonstrated efficacy in clinical trials for other inflammatory conditions and are being investigated for Crohn's Disease. Additionally, Janus kinase (JAK) inhibitors like Tofacitinib and Tyrosine kinase 2 (TYK2) inhibitors are also emerging as potential treatments due to their role in modulating inflammatory pathways.

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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).

Must not have

Patient with an inflammatory bowel disease (IBD) diagnosis other than CD.

Have had any kind of bowel resection or diversion within 4 months or any other intra-abdominal surgery within 3 months prior to visit 1. Patients with current ileostomy, colostomy, or ileorectal anastomosis are excluded.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 104 days

Summary

This trial is for adults with moderate to severe Crohn's disease. It tests if a new medicine, BI 706321, combined with ustekinumab, can help reduce symptoms. Participants take daily pills and receive regular injections, and their health is closely monitored. Ustekinumab is approved for the treatment of Crohn's disease and ulcerative colitis.

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.

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.

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

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

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with an inflammatory bowel disease that is not Crohn's disease.

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I have not had recent major abdominal surgery or currently have a stoma.

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I have been treated with ustekinumab before.

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I have not taken experimental drugs for Crohn's disease.

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I have had severe colon issues or growths, unless they were successfully removed.

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I have not received any live vaccines in the last 4 weeks.

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My heart's electrical activity (QT interval) is longer than normal.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Crohn's Disease, such as the investigational drug BI 706321 and ustekinumab, work by modulating the immune response to reduce inflammation. BI 706321 potentially targets inflammatory pathways, while ustekinumab is a monoclonal antibody that inhibits interleukin-12 (IL-12) and interleukin-23 (IL-23). These cytokines play a key role in the inflammatory process of Crohn's Disease. By targeting these pathways, these treatments aim to decrease inflammation, promote mucosal healing, and maintain remission, which is crucial for improving the quality of life and reducing the need for surgical interventions in Crohn's Disease patients.

Phenome-driven disease genetics prediction toward drug discovery.