Phase
Condition
Scar Tissue
Cystic Fibrosis
Lung Disease
Treatment
Brensocatib
Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants must be ≥18 years of age at the time of signing the informed consent.
Male or female participants with a confirmed diagnosis of CF related lung disease:
Percent predicted forced expiratory volume in 1 second (ppFEV1) between 40% to 90% (inclusive) at Screening Visit and at Baseline.
Stable CF treatment for at least 30 days before screening and willing to remainon a stable regimen throughout the treatment period.
Has a body mass index ≥18 kg/m^2.
Male and female participants must use contraceptives that are consistent with localregulations regarding the methods of contraception for those participating inclinical studies.
Male participants, who are not sterile, with female partners of childbearingpotential must be using effective contraception from Day 1 to at least 90 daysafter the last dose.
Women must be postmenopausal (defined as no menses for 12 months without analternative medical cause), surgically sterile, or using highly effectivecontraception methods (i.e., methods that alone or in combination achieve <1%unintended pregnancy rates per year when used consistently and correctly) fromDay 1 to at least 90 days after the last dose.
Female participants of childbearing potential must have a negative serum pregnancytest at Screening.
Male participants with pregnant or nonpregnant women of childbearing potentialpartners must use a condom.
Exclusion
Exclusion Criteria:
Severe or unstable CF, per Investigator's judgement.
Currently being treated for allergic bronchopulmonary aspergillosis ornontuberculous mycobacteria or tuberculosis.
Active and current infection by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
History of malignancy in the past 5 years, except completely treated in situcarcinoma of the cervix and completely treated non-metastatic squamous or basal cellcarcinoma of the skin.
Established diagnosis of hepatitis B viral infection or positive for hepatitis Bsurface antigen (HBsAg) at Screening.
Established diagnosis of hepatitis C virus (HCV) infection at Screening.Participants positive for hepatitis C antibody are eligible only if HCV RNA isnegative.
History of human immunodeficiency virus (HIV) infection.
Acute upper or lower respiratory tract infection, pulmonary exacerbation, or changesin therapy (including intravenous and oral antibiotics) for pulmonary disease within 4 weeks prior to Day 1 (administration of the first dose of study drug).Participants meeting this criterion could be rescreened 4 weeks after resolution ofsymptoms.
History of prolonged QT/QTc interval with QTcF >480 millisecond (msec) at Screening.
History of solid organ or hematological transplantation.
Have diagnosed periodontal disease and are either:
Currently treated by a dentist for this condition or
Expected to have periodontal disease-related procedures within the studyperiod.
Received any live attenuated vaccine within 4 weeks prior Screening.
Ongoing participation in another therapeutic clinical study or prior participationin an investigational drug study within 90 days prior to Screening.
Known history of hypersensitivity to brensocatib or any of its excipients.
Use of any immunomodulatory agents within 4 weeks before the Screening Visit isprohibited during the study through end of study (including, but not limited to:bortezomib, ixazomib, thalidomide, cyclophosphamide, mycophenolate, Janus kinaseinhibitors, interferon gamma (IFN-γ], and azathioprine).
Continuous use of high-dose non-steroidal anti-inflammatory drugs (NSAIDs) isprohibited during the study through end of study.
History of alcohol, medication, or illicit drug abuse.
Current smoker, as defined by Centers for Disease Control and Prevention: An adultwho has smoked 100 cigarettes in his or her lifetime and who currently smokescigarettes.
Study Design
Connect with a study center
USA001
Gainesville, Florida 32610
United StatesSite Not Available
USA016
Augusta, Georgia 30912
United StatesSite Not Available
USA025
Glenview, Illinois 60025
United StatesSite Not Available
USA011
Boston, Massachusetts 02115
United StatesSite Not Available
USA023
Ann Arbor, Michigan 48109
United StatesSite Not Available
USA002
St Louis, Missouri 63101
United StatesSite Not Available
USA022
New York, New York 10032
United StatesSite Not Available
USA006
Cleveland, Ohio 44195
United StatesSite Not Available
USA008
Cleveland, Ohio 44106
United StatesSite Not Available
USA018
Portland, Oregon 97239
United StatesSite Not Available
USA009
Charleston, South Carolina 29425
United StatesSite Not Available
USA017
Nashville, Tennessee 37232
United StatesSite Not Available
USA004
Dallas, Texas 75390
United StatesSite Not Available
USA003
Tyler, Texas 75708
United StatesSite Not Available

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