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Verducatib for Bronchiectasis

Not yet recruiting at 380 trial locations
Age: Any Age
Sex: Any
Trial Phase: Phase 3
Sponsor: Boehringer Ingelheim
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is for adults and adolescents who are at least 12 years old and have bronchiectasis. People can participate if they completed a previous study with the study medicine called verducatib. The purpose of this study is to find out how well verducatib is tolerated when people with bronchiectasis take it for a long time. The study also looks at breathing problems, how often lung flare-ups happen, and how quickly lung function changes.

This is a roll-over study for participants who completed a previous study with verducatib: AIRTIVITY® (1397-0014) or CLAIRLEAF® (1397-0017). All participants receive verducatib. Participants take verducatib as tablets once a day at home. They may continue their usual treatment for bronchiectasis during the study.

Participants can stay in the study for up to 1 year and 9 months. Treatment with verducatib can continue for up to 1 year and 6 months. About 6 study visits are done at the study site and about 4 are done by phone. At all visits, the doctors check participants' health and collect information on any health problems that occur during the study. The doctors also look at lung flare-ups and measure lung function over time.

Are You a Good Fit for This Trial?

This trial is for people aged 12 and older with bronchiectasis who have already finished a previous study using verducatib. Participants must be able to continue taking the medication and attend regular check-ups.

Inclusion Criteria

I am male or I am a woman using highly effective birth control.
I completed the full treatment in trial 1397-0014 or 1397-0017 as planned.
Signed and dated written informed consent and assent, if applicable, prior to admission to the trial, in accordance with GCP and local legislation

Exclusion Criteria

I have moderate or severe liver disease.
I need to keep taking medications that may interfere with the trial.
Medical examination or laboratory findings at Visit 1 or last safety assessment within 6 weeks that may put participant at risk as per investigator's opinion
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What Are the Treatments Tested in This Trial?

Interventions

  • Verducatib

Trial Overview

The study tests how well people tolerate long-term use of verducatib tablets taken daily at home for up to 1.5 years. All participants receive the same treatment, and their lung health is closely monitored.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Participants with bronchiectasis rolling over from parent trialsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials
2,566
Recruited
16,150,000+

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