BI 1291583 for Bronchiectasis

Recruiting in Palo Alto (17 mi)

+109 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Boehringer Ingelheim

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This study is open to adults aged 18 years and older with bronchiectasis. People can join the study if they were previously enrolled in another study with BI 1291583 (1397-0012: Airleafᵀᴹ or 1397-0013 Clairaflyᵀᴹ). The purpose of this study is to find out whether a medicine called BI 1291583 helps people with bronchiectasis, an inflammatory lung condition. The investigators also want to know how well people with this condition can tolerate BI 1291583 in the long term. Participants take a low, medium, or high dose of BI 1291583 as a tablet once a day for up to 1 year. Participants who were taking placebo in the AirleafTM or ClairaflyTM study are put into the BI 1291583 dosage groups randomly, which means by chance. Placebo tablets look like BI1291583 but do not contain any medicine. Participants who were taking BI 1291583 in the AirleafTM or ClairaflyTM study continue to take the same dose. Participants visit the study site 10 times and get 4 phone calls from the site staff. During the visits, the doctors collect information on any health problems of the participants. The doctors also check whether BI 1291583 helps reduce the symptoms of bronchiectasis.

Research Team

Eligibility Criteria

Adults with bronchiectasis who previously participated in the Airleafᵀᴹ study can join this trial. They must consent to the study, be able to use effective birth control methods if applicable, and have completed prior treatment as per protocol. People with certain infections, liver disease, recent vaccinations or infections, or specific medical conditions are excluded.

Inclusion Criteria

I have signed and understand the consent form for this trial.

Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly, as well as one barrier method

I am either male or female.

Exclusion Criteria

You have a positive test for hepatitis B, hepatitis C, or HIV. If these test results change after you join the study, you may not be able to continue participating.

I have been newly diagnosed with extensive warts.

I have been newly diagnosed with a lung condition due to a fungal infection and need treatment.

Treatment Details

Interventions

• BI 1291583 (Anti-inflammatory agent)
• Placebo matching BI 1291583 (Drug)

Trial Overview The trial is testing BI 1291583's long-term effects on bronchiectasis symptoms. Participants will take a low, medium, or high dose of BI 1291583 daily for up to a year. Some participants will receive a placebo instead. The study involves nine site visits and four phone calls to monitor health outcomes.

Participant Groups

Group I: BI 1291583 medium dose arm Experimental Treatment 2 Interventions

Group II: BI 1291583 low dose arm Experimental Treatment 2 Interventions

Group III: BI 1291583 high dose arm Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+