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The main objective of the study is to evaluate the pharmacokinetics of brensocatib in participants with cystic fibrosis following once daily oral administration of study drug and to evaluate the safety of brensocatib compared to placebo in participants with cystic fibrosis (CF) over the 4-week treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brensocatib 10 mg | Experimental | Participants received brensocatib at a dose of 10 mg once per day for 28 days. |
|
| Brensocatib 25 mg | Experimental | Participants received brensocatib at a dose of 25 mg once per day for 28 days. |
|
| Brensocatib 40 mg | Experimental | Participants received brensocatib at a dose of 40 mg once per day for 28 days. |
|
| Placebo | Placebo Comparator | Participants received a placebo matching brensocatib once per day for 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brensocatib | Drug | Oral tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of Brensocatib on Day 1 | Predose and 0.5, 1, 2, 4, 6, 8, and 24 hours postdose on Day 1 | |
| Cmax of Brensocatib on Day 28 | Predose and at 0.5, 1, 2, 4, 6, 8, 24, and 168 hours postdose on Day 28 | |
| Time to Maximum Plasma Concentration (Tmax) of Brensocatib on Day 1 | Predose and 0.5, 1, 2, 4, 6, 8, and 24 hours postdose on Day 1 | |
| Tmax of Brensocatib on Day 28 | Predose and at 0.5, 1, 2, 4, 6, 8, 24, and 168 hours postdose on Day 28 | |
| Area Under the Concentration-time Curve From Time 0 to 24 Hours Postdose (AUC0-24) of Brensocatib in Plasma on Day 1 | Predose and 0.5, 1, 2, 4, 6, 8, and 24 hours postdose on Day 1 | |
| AUC0-24 of Brensocatib in Plasma on Day 28 | Predose and at 0.5, 1, 2, 4, 6, 8, and 24 hours postdose on Day 28 | |
| Elimination Half-life (t1/2) of Brensocatib in Plasma on Day 28 | Predose and at 0.5, 1, 2, 4, 6, 8, 24, and 168 hours postdose on Day 28 | |
| Number of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE) | A TEAE is defined as any adverse event (AE) that occurred after the first dose of study investigational medicinal product (IMP) and within 28 days after the last dose of study IMP. | Up to Day 56 |
| Measure | Description | Time Frame |
|---|---|---|
| Dose Proportionality of Brensocatib for Dose Levels 10mg to 40mg Using Brensocatib Cmax After Administration of Brensocatib on Days 1 and 28 | Analysis of dose dependency for brensocatib Cmax was performed using a power law model. The logarithm of the Cmax was linearly related to the logarithm of the dose using a linear regression analysis. Slope of the regression and corresponding 90% CIs are presented. Slope (90% CI): log(PK parameter) = intercept + slope * log(dose) + error term, for relationship between each of the dose levels. All 3 dose levels are included in the same model for the dose-exposure relationship. |
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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:
Has a body mass index ≥18 kg/m^2.
Male and female participants must use contraceptives that are consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Female participants of childbearing potential must have a negative serum pregnancy test at Screening.
Male participants with pregnant or nonpregnant women of childbearing potential partners must use a condom.
Exclusion Criteria:
Severe or unstable CF, per Investigator's judgement.
Currently being treated for allergic bronchopulmonary aspergillosis or nontuberculous 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 situ carcinoma of the cervix and completely treated non-metastatic squamous or basal cell carcinoma of the skin.
Established diagnosis of hepatitis B viral infection or positive for hepatitis B surface 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 is negative.
History of human immunodeficiency virus (HIV) infection.
Acute upper or lower respiratory tract infection, pulmonary exacerbation, or changes in 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 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:
Received any live attenuated vaccine within 4 weeks prior Screening.
Ongoing participation in another therapeutic clinical study or prior participation in 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 is prohibited during the study through end of study (including, but not limited to: bortezomib, ixazomib, thalidomide, cyclophosphamide, mycophenolate, Janus kinase inhibitors, interferon gamma (IFN-γ], and azathioprine).
Continuous use of high-dose non-steroidal anti-inflammatory drugs (NSAIDs) is prohibited 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 who has smoked 100 cigarettes in his or her lifetime and who currently smokes cigarettes.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USA001 | Gainesville | Florida | 32610 | United States | ||
| USA016 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40753522 | Derived | Konstan MW, Tolle JJ, DiMango E, Flume PA, Usansky H, Teper A, Ramirez CN, Flarakos J, Basso J, Li S, Vergara M. A Phase IIa, Single-Blind, Placebo-Controlled, Parallel-Group Study to Assess Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Brensocatib in Adults with Cystic Fibrosis. Clin Pharmacokinet. 2025 Oct;64(10):1561-1574. doi: 10.1007/s40262-025-01550-z. Epub 2025 Aug 3. |
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Participants took part in the study at investigational sites in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Brensocatib 10 mg | Participants received brensocatib at a dose of 10 mg orally once per day for 28 days. |
| FG001 | Brensocatib 25 mg | Participants received brensocatib at a dose of 25 mg orally once per day for 28 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 26, 2022 | Oct 30, 2025 |
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| Placebo | Drug | Oral tablet |
|
| Day 1: Predose and 0.5, 1, 2, 4, 6, 8, and 24 hours postdose; Day 28: Predose and at 0.5, 1, 2, 4, 6, 8, 24 and 168 hours postdose |
| Dose Proportionality of Brensocatib for Dose Levels 10mg to 40mg Using Brensocatib AUC0-24 After Administration of Brensocatib on Days 1 and 28 | Analysis of dose dependency for brensocatib AUC0-24 was performed using a power law model. The logarithm of the AUC0-24 was linearly related to the logarithm of the dose using a linear regression analysis. Slope of the regression and corresponding 90% CIs are presented. Slope (90% CI): log(PK parameter) = intercept + slope * log(dose) + error term, for relationship between each of the dose levels. All 3 dose levels are included in the same model for the dose-exposure relationship. | Day 1: Predose and 0.5, 1, 2, 4, 6, 8, and 24 hours postdose; Day 28: Predose and at 0.5, 1, 2, 4, 6, 8, and 24 hours postdose |
| AUClast of Brensocatib in Plasma on Days 1 and 28 | Day 1: Predose and 0.5, 1, 2, 4, 6, 8, and 24 hours postdose; Day 28: Predose and at 0.5, 1, 2, 4, 6, 8, 24 and 168 hours postdose |
| Dose Proportionality of Brensocatib for Dose Levels 10mg to 40mg Using Brensocatib AUClast, After Administration of Brensocatib on Days 1 and 28 | Analysis of dose dependency for brensocatib AUClast was performed using a power law model. The logarithm of the AUClast was linearly related to the logarithm of the dose using a linear regression analysis. Slope of the regression and corresponding 90% CIs are presented. Slope (90% CI): log(PK parameter) = intercept + slope * log(dose) + error term, for relationship between each of the dose levels. All 3 dose levels are included in the same model for the dose-exposure relationship. | Day 1: Predose and 0.5, 1, 2, 4, 6, 8, and 24 hours postdose; Day 28: Predose and at 0.5, 1, 2, 4, 6, 8, 24 and 168 hours postdose |
| Augusta |
| Georgia |
| 30912 |
| United States |
| USA025 | Glenview | Illinois | 60025 | United States |
| USA011 | Boston | Massachusetts | 02115 | United States |
| USA023 | Ann Arbor | Michigan | 48109 | United States |
| USA002 | St Louis | Missouri | 63101 | United States |
| USA022 | New York | New York | 10032 | United States |
| USA008 | Cleveland | Ohio | 44106 | United States |
| USA006 | Cleveland | Ohio | 44195 | United States |
| USA018 | Portland | Oregon | 97239 | United States |
| USA009 | Charleston | South Carolina | 29425 | United States |
| USA017 | Nashville | Tennessee | 37232 | United States |
| USA004 | Dallas | Texas | 75390 | United States |
| USA003 | Tyler | Texas | 75708 | United States |
| FG002 | Brensocatib 40 mg | Participants received brensocatib at a dose of 40 mg orally once per day for 28 days. |
| FG003 | Placebo | Participants received a placebo matching brensocatib orally once per day for 28 days. |
| COMPLETED |
|
| NOT COMPLETED |
|
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Brensocatib 10 mg | Participants received brensocatib at a dose of 10 mg orally once per day for 28 days. |
| BG001 | Brensocatib 25 mg | Participants received brensocatib at a dose of 25 mg orally once per day for 28 days. |
| BG002 | Brensocatib 40 mg | Participants received brensocatib at a dose of 40 mg orally once per day for 28 days. |
| BG003 | Placebo | Participants received a placebo matching brensocatib orally once per day for 28 days. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Plasma Concentration (Cmax) of Brensocatib on Day 1 | Pharmacokinetic (PK) Analysis Set included all randomized participants who received at least 1 dose of brensocatib (actual treatment) and had sufficient data to calculate at least 1 PK parameter. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | Predose and 0.5, 1, 2, 4, 6, 8, and 24 hours postdose on Day 1 |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | Cmax of Brensocatib on Day 28 | PK Analysis Set included all randomized participants who received at least 1 dose of brensocatib (actual treatment) and had sufficient data to calculate at least 1 PK parameter. Overall number analyzed is the number of participants with data available for analyses. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Predose and at 0.5, 1, 2, 4, 6, 8, 24, and 168 hours postdose on Day 28 |
|
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| Primary | Time to Maximum Plasma Concentration (Tmax) of Brensocatib on Day 1 | PK Analysis Set included all randomized participants who received at least 1 dose of brensocatib (actual treatment) and had sufficient data to calculate at least 1 PK parameter. | Posted | Median | Full Range | hours | Predose and 0.5, 1, 2, 4, 6, 8, and 24 hours postdose on Day 1 |
|
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| Primary | Tmax of Brensocatib on Day 28 | PK Analysis Set included all randomized participants who received at least 1 dose of brensocatib (actual treatment) and had sufficient data to calculate at least 1 PK parameter. Overall number analyzed is the number of participants with data available for analyses. | Posted | Median | Full Range | hours | Predose and at 0.5, 1, 2, 4, 6, 8, 24, and 168 hours postdose on Day 28 |
|
| |||||||||||||||||||||||||||||||||
| Primary | Area Under the Concentration-time Curve From Time 0 to 24 Hours Postdose (AUC0-24) of Brensocatib in Plasma on Day 1 | PK Analysis Set included all randomized participants who received at least 1 dose of brensocatib (actual treatment) and had sufficient data to calculate at least 1 PK parameter. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours*ng/mL | Predose and 0.5, 1, 2, 4, 6, 8, and 24 hours postdose on Day 1 |
|
| |||||||||||||||||||||||||||||||||
| Primary | AUC0-24 of Brensocatib in Plasma on Day 28 | PK Analysis Set included all randomized participants who received at least 1 dose of brensocatib (actual treatment) and had sufficient data to calculate at least 1 PK parameter. Overall number analyzed is the number of participants with data available for analyses. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours*ng/mL | Predose and at 0.5, 1, 2, 4, 6, 8, and 24 hours postdose on Day 28 |
|
| |||||||||||||||||||||||||||||||||
| Primary | Elimination Half-life (t1/2) of Brensocatib in Plasma on Day 28 | PK Analysis Set included all randomized participants who received at least 1 dose of brensocatib (actual treatment) and had sufficient data to calculate at least 1 PK parameter. Overall number analyzed is the number of participants with data available for analyses. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | Predose and at 0.5, 1, 2, 4, 6, 8, 24, and 168 hours postdose on Day 28 |
|
| |||||||||||||||||||||||||||||||||
| Primary | Number of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE) | A TEAE is defined as any adverse event (AE) that occurred after the first dose of study investigational medicinal product (IMP) and within 28 days after the last dose of study IMP. | Safety Analysis Set included all randomized participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Up to Day 56 |
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| Secondary | Dose Proportionality of Brensocatib for Dose Levels 10mg to 40mg Using Brensocatib Cmax After Administration of Brensocatib on Days 1 and 28 | Analysis of dose dependency for brensocatib Cmax was performed using a power law model. The logarithm of the Cmax was linearly related to the logarithm of the dose using a linear regression analysis. Slope of the regression and corresponding 90% CIs are presented. Slope (90% CI): log(PK parameter) = intercept + slope * log(dose) + error term, for relationship between each of the dose levels. All 3 dose levels are included in the same model for the dose-exposure relationship. | PK Analysis Set included all randomized participants who received at least 1 dose of brensocatib (actual treatment) and had sufficient data to calculate at least 1 PK parameter. Number analyzed signifies the number of participants with data available for analysis at the specified time point. | Posted | Number | 90% Confidence Interval | log(ng/ml) per log(mg) | Day 1: Predose and 0.5, 1, 2, 4, 6, 8, and 24 hours postdose; Day 28: Predose and at 0.5, 1, 2, 4, 6, 8, 24 and 168 hours postdose |
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| Secondary | Dose Proportionality of Brensocatib for Dose Levels 10mg to 40mg Using Brensocatib AUC0-24 After Administration of Brensocatib on Days 1 and 28 | Analysis of dose dependency for brensocatib AUC0-24 was performed using a power law model. The logarithm of the AUC0-24 was linearly related to the logarithm of the dose using a linear regression analysis. Slope of the regression and corresponding 90% CIs are presented. Slope (90% CI): log(PK parameter) = intercept + slope * log(dose) + error term, for relationship between each of the dose levels. All 3 dose levels are included in the same model for the dose-exposure relationship. | PK Analysis Set included all randomized participants who received at least 1 dose of brensocatib (actual treatment) and had sufficient data to calculate at least 1 PK parameter. Number analyzed signifies the number of participants with data available for analysis at the specified time point. | Posted | Number | 90% Confidence Interval | log(ng*h/mL) per log(mg) | Day 1: Predose and 0.5, 1, 2, 4, 6, 8, and 24 hours postdose; Day 28: Predose and at 0.5, 1, 2, 4, 6, 8, and 24 hours postdose |
|
| ||||||||||||||||||||||||||||||||
| Secondary | AUClast of Brensocatib in Plasma on Days 1 and 28 | PK Analysis Set included all randomized participants who received at least 1 dose of brensocatib (actual treatment) and had sufficient data to calculate at least 1 PK parameter. Number analyzed signifies the number of participants with data available for analysis at the specified time point. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours*ng/mL | Day 1: Predose and 0.5, 1, 2, 4, 6, 8, and 24 hours postdose; Day 28: Predose and at 0.5, 1, 2, 4, 6, 8, 24 and 168 hours postdose |
|
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| Secondary | Dose Proportionality of Brensocatib for Dose Levels 10mg to 40mg Using Brensocatib AUClast, After Administration of Brensocatib on Days 1 and 28 | Analysis of dose dependency for brensocatib AUClast was performed using a power law model. The logarithm of the AUClast was linearly related to the logarithm of the dose using a linear regression analysis. Slope of the regression and corresponding 90% CIs are presented. Slope (90% CI): log(PK parameter) = intercept + slope * log(dose) + error term, for relationship between each of the dose levels. All 3 dose levels are included in the same model for the dose-exposure relationship. | PK Analysis Set included all randomized participants who received at least 1 dose of brensocatib (actual treatment) and had sufficient data to calculate at least 1 PK parameter. Number analyzed signifies the number of participants with data available for analysis at the specified time point. | Posted | Number | 90% Confidence Interval | log(ng*h/mL) per log(mg) | Day 1: Predose and 0.5, 1, 2, 4, 6, 8, and 24 hours postdose; Day 28: Predose and at 0.5, 1, 2, 4, 6, 8, 24 and 168 hours postdose |
|
|
Up to Day 56
Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Brensocatib 10 mg | Participants received brensocatib at a dose of 10 mg orally once per day for 28 days. | 0 | 8 | 0 | 8 | 4 | 8 |
| EG001 | Brensocatib 25 mg | Participants received brensocatib at a dose of 25 mg orally once per day for 28 days. | 0 | 8 | 0 | 8 | 5 | 8 |
| EG002 | Brensocatib 40 mg | Participants received brensocatib at a dose of 40 mg orally once per day for 28 days. | 0 | 8 | 1 | 8 | 4 | 8 |
| EG003 | Placebo | Participants received a placebo matching brensocatib orally once per day for 28 days. | 0 | 5 | 0 | 5 | 2 | 5 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infective pulmonary exacerbation of cystic fibrosis | Infections and infestations | MedDRA version 25.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infective pulmonary exacerbation of cystic fibrosis | Infections and infestations | MedDRA version 25.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA version 25.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Sputum increased | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Gastric fistula | Gastrointestinal disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Gastroenteritis | Gastrointestinal disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA version 25.1 | Systematic Assessment |
| |
| Corneal abrasion | Eye disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Influenza A virus test positive | Infections and infestations | MedDRA version 25.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Ophthalmic migraine | Nervous system disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Chromaturia | Renal and urinary disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Renal pain | Renal and urinary disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Tonsillar disorder | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Tonsillolith | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 25.1 | Systematic Assessment |
|
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Insmed Medical Information | Insmed Incorporated | 1-844-446-7633 | medicalinformation@insmed.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 21, 2022 | Oct 30, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000619932 | brensocatib |
Not provided
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Participants |
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