Ireland
--:--IST
Starting soon Phase 3

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

NCT07915219 · tracked via the Priya Life Science UK tracker
Phase
Phase 3
Started
2027-01-11
Last updated
2026-11-04

Condition(s) studied

Bronchiectasis

Investigational drug(s) / intervention(s)

verducatib →

verducatib: verducatib

Study summary

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.

Eligibility

Sex
ALL
Min age
12 Years
Max age
—
Healthy volunteers
No
Inclusion criteria: 1. 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. 2. 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. 3. 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. Exclusion criteria: 1. 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. 2. 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. 3. 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). 4. 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. 5. Diagnosis of primary or secondary immunodeficiency made after end of treatment in preceding trial. 6. 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. 7. 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. 8. 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.

Primary outcome measure(s)

  • Occurrence of treatment-emergent adverse events (TEAEs) over the course of this trial — up to 78 weeks

Trial sites (383)

FacilityCityRegionStatus
University of Arizona Tucson Arizona
Newport Native MD, Inc Newport Beach California
Paradigm Clinical Research - Redding Redding California
University of California Davis Sacramento California
National Jewish Health Denver Colorado
Meris Clinical Research-Brandon-69466 Brandon Florida
University of Florida College of Medicine Jacksonville Florida
Mayo Clinic - Florida Jacksonville Florida
Essence MD Research Naples Florida
Vantage Clinical Trials - Tampa Tampa Florida
Cleveland Clinic Florida Weston Florida
Augusta University Augusta Georgia
University of Kansas Medical Center Kansas City Kansas
University of Michigan Ann Arbor Michigan
Mayo Clinic, Rochester Rochester Minnesota
HealthPartners Specialty Center 401 Building Saint Paul Minnesota
Washington University School of Medicine St Louis Missouri
University of Nebraska Medical Center Omaha Nebraska
New York Medical College - Hawthorne Hawthorne New York
Northwell Health New Hyde Park New York
New York University Langone Medical Center New York New York
Icahn School of Medicine at Mount Sinai New York New York
New York Presbyterian Hospital -Columbia University New York New York
Stern Research Partners, LLC Huntersville North Carolina
Pinehurst Medical Clinic, Inc. - East Pinehurst North Carolina
University of Cincinnati Cincinnati Ohio
University Hospitals Cleveland Medical Center Cleveland Ohio
Clinical Research Associates of Central PA DuBois Pennsylvania
University of Pennsylvania Philadelphia Pennsylvania
Jefferson Health Honickman Center Philadelphia Pennsylvania
Medical University of South Carolina Charleston South Carolina
Clinical Research of Rock Hill Rock Hill South Carolina
Horizon Clinical Research Group Cypress Texas
Baylor University Medical Center Dallas Texas
University of Texas Southwestern Medical Center Dallas Texas
El Paso Pulmonary Association El Paso Texas
University of Texas Medical Branch at Galveston Galveston Texas
Baylor College of Medicine Houston Texas
Metroplex Pulmonary & Sleep Center McKinney Texas
IMA Clinical Research San Antonio San Antonio Texas

+ 343 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07915219 on ClinicalTrials.gov ↗ ← All trials in the UK