A Phase II Study of Ensifentrine in Non-Cystic Fibrosis Bronchiectasis

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Non-cystic Fibrosis Bronchiectasis

In brief

This study is a randomized, double-blind, placebo-controlled study designed to assess the efficacy and safety of ensifentrine inhalation suspension (3 mg) delivered twice daily via standard jet nebulizer up to 52 weeks, compared to placebo, in participants with non-cystic fibrosis bronchiectasis (NCFBE).

Key facts

Study ID

NCT06559150

Run by

Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA

People needed

284

Starts

2024-09-11

Expected to finish

2027-09-24

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males are eligible to participate if they agree to use contraception as described in the contraceptive guidance from Screening and throughout the study and for at least 30 days after the last dose of blinded study medication
• Females are eligible to participate if they are not pregnant, not breastfeeding, and 1 of the following conditions apply:
• Not a woman of childbearing potential (WOCBP) OR
• A WOCBP who agrees to follow the contraceptive guidance from Screening throughout the study and for at least 30 days after the last dose of blinded study medication
• Clinical history consistent with bronchiectasis (cough, chronic sputum production, and/or recurrent respiratory infections) confirmed by chest CT demonstrating bronchiectasis affecting 1 or more lobes. Confirmation may be based on prior chest CT within the prior 5 years; subjects whose past CT image records are not available will require chest CT scan during screening Notes: If a subject has no clinical history consistent with bronchiectasis, they may not be re-screened
• Current sputum producer with a history of chronic expectoration and able to provide sputum sample spontaneously at the clinic during screening
• ≥ 1 documented pulmonary exacerbation defined by an antimicrobial prescription (i.e., antibiotic or antiviral) by a physician for the signs and symptoms of respiratory infections in the past 12 months before screening
• Capable of using the study nebulizer correctly
• Ability to perform acceptable spirometry in accordance with American Thoracic Society and European Respiratory Society guidelines as assessed by the Investigator

You may not qualify if…

• A diagnosis of COPD or a primary diagnosis of asthma, as judged by the investigator
• Bronchiectasis due to cystic fibrosis, primary hypogammaglobulinemia common variable immunodeficiency, severe immunodeficiency, or requirement for treatment with intravenous immunoglobulin
• Current smoker defined as by the Centers for Disease Control and Prevention (CDC)
• Meets both of the following
• Former cigarette smokers with a history of cigarette smoking ≥ 10 pack years at Screening [number of pack years = (number of cigarettes per day / 20) × number of years smoked (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years)]. Pipe and/or cigar use cannot be used to calculate pack-year history. Former smokers are defined as those who have stopped smoking for at least 6 months prior to Screening AND
• Evidence within 1 year prior to randomization of obstructed lung function as shown by forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) ratio of < 0.70
• A diagnosis of primary ciliary dyskinesia (PCD) is not exclusionary. Subjects with a diagnosis of PCD are permitted to be enrolled, but the proportion of subjects with PCD enrolled in the study may be limited
• Current treatment for nontuberculous mycobacterial lung infection, allergic bronchopulmonary aspergillosis, or tuberculosis
• Presence of acute exacerbation or acute infection that required acute treatment within 28 days of randomization
• Use of the following prohibited medications within the designated time periods:
• Chronic, systemic immunomodulatory agents for any chronic indication (including but not limited to the following: methotrexate, systemic corticosteroids, see adalimumab, azathioprine, dupilumab, cyclosporine, hydroxychloroquine, etc.) within 90 days prior to signing the ICF
• CFTR modulators (e.g., ivacaftor, lumacaftor, tezacaftor) within 1 week prior to signing the ICF
• Theophylline and oral PDE4 inhibitors (e.g., roflumilast, apremilast, crisaborole) within 48 hours prior to signing the ICF
• Ohtuvayre at any time prior to signing the ICF
• Initiated or altered therapy within 90 days prior to randomization with:
• oral or inhaled antibiotics as chronic treatment (including macrolides)
• Cyclic antibiotics: defined as prescribed regular cycles of on antibiotic treatment and off antibiotic treatment (for example, but not limited to, 28 days on an antibiotic and 28 days off an antibiotic). Note: Subjects on cyclic antibiotics must be actively taking antibiotics for at least 7 days prior to randomization through the day of randomization
• Dipeptidyl peptidase 1 (DPP1) or cathepsin C (CatC) inhibitor (e.g., brensocatib)
• Initiated or altered therapy with ICS within 4 weeks prior to randomization
• Unable to withhold short-acting beta-agonists or short-acting muscarinic antagonists for ≥ 4 hours prior to spirometry
• Significant hemoptysis (≥ 300 mL or requiring blood transfusion) within 6 weeks prior to randomization
• Currently participating in or scheduled to participate in an intensive pulmonary rehabilitation program (a maintenance rehabilitation program is allowed if their schedule and procedure will be consistent for the duration of the study)
• Current or chronic history of unstable liver disease defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices or persistent jaundice, cirrhosis, or known hepatic or biliary abnormalities except for Gilbert syndrome or asymptomatic gallstones Note: Chronic stable hepatitis B and C is not exclusionary if the subject otherwise meets study entry criteria
• History of or current malignancy of any organ system, treated or untreated within the past 5 years, except for localized basal or squamous cell carcinoma of the skin
• Estimated glomerular filtration rate (eGFR) < 30 mL/min

Where it is running

• Kirklin Clinic of UAB Hospital — Birmingham, Alabama, United States (enrolling)
• University of California Davis Medical Center — Sacramento, California, United States (enrolling)
• So Cal Institute for Respiratory Diseases, Inc. — Los Angeles, California, United States (enrolling)
• MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States (enrolling)
• University of Miami — Miami, Florida, United States (enrolling)
• Emory University at Saint Joseph Pulmonary Clinic — Atlanta, Georgia, United States (enrolling)
• Augusta University — Augusta, Georgia, United States (enrolling)
• National Jewish Health Main Campus — Denver, Colorado, United States (enrolling)
• University of Iowa — Iowa City, Iowa, United States (enrolling)
• University of Kansas Medical Center-Kansas City — Kansas City, Kansas, United States (enrolling)
• Massachusetts General Hospital- 55 Fruit St — Boston, Massachusetts, United States (enrolling)
• University of Michigan Hospital — Ann Arbor, Michigan, United States (enrolling)
• Mayo Clinic — Rochester, Minnesota, United States (enrolling)
• Washington University School of Medicine — St Louis, Missouri, United States (enrolling)
• NYU Langone Health Pulmonary and Critical Care Associates, P.C. - BRANY - PPDS — New York, New York, United States (enrolling)
• University of North Carolina — Chapel Hill, North Carolina, United States (enrolling)
• ASHA Clinical Research — Hammond, Indiana, United States (enrolling)
• Southeastern Research Center — Winston-Salem, North Carolina, United States (enrolling)
• Ohio State University — Columbus, Ohio, United States (enrolling)
• Oregon Health and Science University — Portland, Oregon, United States (enrolling)
• Temple University Hospital — Philadelphia, Pennsylvania, United States (enrolling)
• Medical University of South Carolina (MUSC) - PPDS — Charleston, South Carolina, United States (enrolling)
• Velocity Clinical Research - Spartanburg - PPDS — Spartanburg, South Carolina, United States (enrolling)
• Velocity Clinical Research - Union - PPDS — Union, South Carolina, United States (enrolling)
• Clinical Trials Center of Middle Tennessee — Franklin, Tennessee, United States (enrolling)

Full record on ClinicalTrials.gov

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