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Not yet taking people in Hong KongPhase 3

A Study to Learn How Well People With Bronchiectasis Tolerate Continued Treatment With Verducatib After Earlier Studies (AIRTIVITY®-ON)

Key facts

Who runs it
Boehringer Ingelheim
Where
Hong Kong, Hong KongSee the 2 sitesAlso in 40 other countries, 390 sites
Trial code
Status
Not yet recruiting
Phase
Phase 3
People taking part
1,500 people, planned
Starts
11 Jan 2027
Expected to end
10 Sept 2029
Type of study
Interventional
Treatments tested
  • verducatib
Record updated
12 November 2026

Who can take part

Age
12 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • Participants (adults and adolescents ≥12 years of age) who completed the treatment period in trials 1397-0014 or 1397-0017 as planned per protocol and did not discontinue trial treatment prematurely
  • Male or female participants. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per International Council of Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the participant information
  • Signed and dated written informed consent and assent, if applicable, prior to admission to the trial, in accordance with Good Clinical Practice (GCP) and local legislation

Who cannot take part

  • Participants who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial
  • Moderate or severe liver disease (defined by Child-Pugh score B or C hepatic impairment), unless the investigator determines it is in the best interest of the participant to enrol in the trial
  • Any relevant pulmonary, gastrointestinal, hepatic, renal, cardiovascular, metabolic, immunological, hormonal, or other disorder that, in the opinion of the investigator, may put the participant at risk by participating in the study
  • Participants not expected to comply with the protocol requirements or not expected to complete the trial as scheduled, i.e. chronic alcohol or drug abuse or any other condition that, in the investigator's opinion, makes the participant an unreliable trial participant; Further exclusion criteria apply
  • Estimated glomerular filtration rate (eGFR) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula (adults) and Chronic Kidney Disease Under 25 (CKiD-U25) (adolescents) <30 mL/min at Visit 1 (or at the last safety assessment in the parent trial, if no more than 6 weeks passed since then), unless the investigator determines it is in the best interest of the participant to enrol in the trial
  • An absolute blood neutrophil count <1000/mm\^3 (equivalent to <1000 cells/µL or <10\^9 cells/L) at Visit 1 (or at the last safety assessment in the parent trial, if no more than 6 weeks passed since then)
  • Any findings in the medical examination and/or laboratory value assessed at Visit 1 (or at the last safety assessment in the parent trial, concerning the laboratory tests, if no more than 6 weeks passed since then), that in the opinion of the investigator may put the participant at risk by participating in the trial
  • Diagnosis of primary or secondary immunodeficiency made after end of treatment in preceding trial

Where in Hong Kong

Also in 40 other countries, 390 sites

  • Prince of Wales HospitalHong Kong, Hong KongContact: Boehringer IngelheimNo longer taking part
  • Queen Mary HospitalHong Kong, Hong KongContact: Boehringer IngelheimNo longer taking part

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The group in the trial

  • Participants with bronchiectasis rolling over from parent trialsTreatment being tested

    Participants with bronchiectasis who completed parent trials AIRTIVITY® (1397-0014) or CLAIRLEAF® (1397-0017) and did not prematurely discontinue the trial drug.

    Treatment: verducatib

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
An Open-label, Roll-over Study Evaluating the Long-term Safety and Efficacy of an Oral Dose of Verducatib q.d. in Patients With Bronchiectasis (AIRTIVITY®-ON)
Record updated
12 November 2026