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 in clinicalstudies.
- 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 or nontuberculousmycobacteria 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 situ carcinomaof the cervix and completely treated non-metastatic squamous or basal cell carcinomaof 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. Participantspositive for hepatitis C antibody are eligible only if HCV RNA is negative.
- 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 4weeks prior to Day 1 (administration of the first dose of study drug). Participantsmeeting this criterion could be rescreened 4 weeks after resolution of symptoms.
- 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 study period.
- Received any live attenuated vaccine within 4 weeks prior Screening.
- Ongoing participation in another therapeutic clinical study or prior participation inan 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 adult whohas smoked 100 cigarettes in his or her lifetime and who currently smokes cigarettes.
Study Design
Connect with a study center
USA021
Birmingham, Alabama 35233
United StatesSite Not Available
USA012
La Jolla, California 92037-1300
United StatesSite Not Available
USA019
Palo Alto, California 94304-1524
United StatesSite Not Available
USA013
Sacramento, California 95817-2201
United StatesSite Not Available
USA024
Santa Barbara, California 93102
United StatesSite Not Available
USA001
Gainesville, Florida 32610-0001
United StatesSite Not Available
USA005
Orlando, Florida 32810
United StatesSite Not Available
USA020
Atlanta, Georgia 30322-1014
United StatesSite Not Available
USA016
Augusta, Georgia 30912-0004
United StatesSite Not Available
USA025
Glenview, Illinois 60025-7645
United StatesSite Not Available
USA025
Northfield, Illinois 60093
United StatesSite Not Available
USA011
Boston, Massachusetts 02115-5724
United StatesSite Not Available
USA023
Ann Arbor, Michigan 48109
United StatesSite Not Available
USA002
Saint Louis, Missouri 63101
United StatesSite Not Available
USA022
New York, New York 10032-3720
United StatesSite Not Available
USA006
Cleveland, Ohio 44195-0001
United StatesSite Not Available
USA008
Cleveland, Ohio 44106-1716
United StatesSite Not Available
USA007
Columbus, Ohio 43205
United StatesSite Not Available
USA018
Portland, Oregon 97239-3011
United StatesSite Not Available
USA014
Pittsburgh, Pennsylvania 15224-1334
United StatesSite Not Available
USA009
Charleston, South Carolina 29425-8900
United StatesSite Not Available
USA017
Nashville, Tennessee 37232-0028
United StatesSite Not Available
USA004
Dallas, Texas 75390-7208
United StatesSite Not Available
USA010
Houston, Texas 77030
United StatesSite Not Available
USA003
Tyler, Texas 75708
United StatesSite Not Available
USA015
Salt Lake City, Utah 84108-1287
United StatesSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.