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New treatment option for Bronchiectasis
Official title The AIRTIVITY™ Study: A Study to Find Out Whether BI 1291583 Helps People With Bronchiectasis
ClinicalTrials.gov ID: NCT06872892
What this study is testing
What is BI 1291583?
BI 1291583 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for bronchiectasis.
Also referred to as Verducatib.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is open to adults and adolescents aged 12 to under 18 with bronchiectasis. People can participate in this study if they produce sputum and have had flare-ups (also called exacerbations).
- Phase 3: a large, late-stage study
- Time commitment: about 1 year
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- Male or female participants. Woman of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per...
- Signed and dated written informed consent and assent, if applicable, prior to admission to the study, in accordance with GCP and local legislation.
- Age of participants when signing the informed consent/assent ≥12 years. \-- Adolescents need to weigh at least 35 kg at Visit 1.
- Clinical history consistent with bronchiectasis (e.g. cough, chronic sputum production, recurrent respiratory infections) and investigator confirmed...
- Adult participants should be able to produce sputum for Pseudomonas aeruginosa assessment during the screening period.
You likely can't join if
- Any new or newly diagnosed condition of primary or secondary immunodeficiency within 1 year before randomisation.
- Allergic bronchopulmonary aspergillosis being treated or requiring treatment.
- Tuberculosis or non-tuberculosis mycobacterial infection being treated or requiring treatment
- Any findings in the medical examination and/or laboratory value assessed at Screening Visit 1 or during screening period, that in the opinion of the...
- Any clinically relevant (at the discretion of the investigator) acute respiratory infection or ongoing pulmonary exacerbation at screening visit or...
- Any relevant pulmonary, gastrointestinal, hepatic, renal, cardiovascular, metabolic, immunological, hormonal, or other disorder that, in the opinion...
See the full eligibility criteria
- Male or female participants. Woman 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...
- Signed and dated written informed consent and assent, if applicable, prior to admission to the study, in accordance with GCP and local legislation.
- Age of participants when signing the informed consent/assent ≥12 years. \-- Adolescents need to weigh at least 35 kg at Visit 1.
- Clinical history consistent with bronchiectasis (e.g. cough, chronic sputum production, recurrent respiratory infections) and investigator confirmed diagnosis of bronchiectasis by CT scan where bronchiectasis has been...
- Adult participants should be able to produce sputum for Pseudomonas aeruginosa assessment during the screening period.
- History of documented pulmonary exacerbations (assessed and recorded by the investigator) requiring antibiotic treatment. In the 12 months before Visit 1, participants must have had either:
- at least 2 exacerbations, or
- at least 1 exacerbation and an St. George's Respiratory Questionnaire (SGRQ) Symptoms score of \>40 at screening Visit 1 (adults only)
- at least 1 exacerbation and high symptom burden according to the investigator's judgement (adolescents only) For participants on oral or inhaled antibiotics as chronic treatment for bronchiectasis and participants on...
- Any new or newly diagnosed condition of primary or secondary immunodeficiency within 1 year before randomisation.
- Allergic bronchopulmonary aspergillosis being treated or requiring treatment.
- Tuberculosis or non-tuberculosis mycobacterial infection being treated or requiring treatment
- Any findings in the medical examination and/or laboratory value assessed at Screening Visit 1 or during screening period, that in the opinion of the investigator may put the participant at risk by participating in the...
- Any clinically relevant (at the discretion of the investigator) acute respiratory infection or ongoing pulmonary exacerbation at screening visit or during the screening unless recovered in the opinion of the...
- 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...
- Major surgery (major according to the investigator's assessment) performed within 6 weeks prior to randomisation or scheduled during trial period.
- Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated in situ non-melanoma skin cancers or in situ carcinoma of uterine cervix.
- Evidence or medical history of moderate or severe liver disease (Child-Pugh score B or C hepatic impairment).
- estimated Glomerular Filtration Rate (eGFR) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula (adults) or Chronic Kidney Disease Under 25 (CKiD-U25) (adolescents) \<30 mL/min at Visit 1.
- Previous treatment with a dipeptidyl peptidase-1 (DPP1) (Cathepsin C (CatC)) inhibitor. (Note: Participants that were assigned by chance and only received placebo in studies with DPP1 (CatC) inhibitor are allowed.)...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Anchorage, Alaska, United States
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Newport Beach, California, United States
- Redding, California, United States
- Sacramento, California, United States
- San Francisco, California, United States
- Ventura, California, United States
- Denver, Colorado, United States
- North Haven, Connecticut, United States
- Washington D.C., District of Columbia, United States
- Altamonte Springs, Florida, United States
- Brandon, Florida, United States
- Clearwater, Florida, United States
- Gainesville, Florida, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Naples, Florida, United States
- Tampa, Florida, United States
+ 377 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 1 year per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Anchorage, Alaska, United States; Phoenix, Arizona, United States; Tucson, Arizona, United States; Newport Beach, California, United States; Redding, California, United States and 391 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.