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Cystic FibrosisPhase 2NCT05090904

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Brensocatib Tablets in Adults With Cystic Fibrosis

A Phase 2 study testing Brensocatib in people with Cystic Fibrosis, run by Insmed Incorporated at 14 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cystic Fibrosis
What is being tested?
Brensocatib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
29 participants
Where
14 sitesUnited States
Study dates
30 Nov 2021to 1 Nov 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 remain on 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 local regulations regarding the methods of contraception for those participating in clinical studies.
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  • Male participants, who are not sterile, with female partners of childbearing potential must be using effective contraception from Day 1 to at least 90 days after the last dose.
  • Women must be postmenopausal (defined as no menses for 12 months without an alternative medical cause), surgically sterile, or using highly effective contraception methods (i.e., methods that alone or in combination achieve <1% unintended pregnancy rates per year when used consistently and correctly) from Day 1 to at least 90 days after the last dose.
  • 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.

Who cannot join

  • 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.
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  • 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:
  • 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 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.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

United States14 sites

  • USA023

    Ann Arbor, Michigan, 48109

  • USA016

    Augusta, Georgia, 30912

  • USA011

    Boston, Massachusetts, 02115

  • USA009

    Charleston, South Carolina, 29425

  • USA008

    Cleveland, Ohio, 44106

  • USA006

    Cleveland, Ohio, 44195

  • USA004

    Dallas, Texas, 75390

  • USA001

    Gainesville, Florida, 32610

  • USA025

    Glenview, Illinois, 60025

  • USA017

    Nashville, Tennessee, 37232

  • USA022

    New York, New York, 10032

  • USA018

    Portland, Oregon, 97239

  • USA002

    St Louis, Missouri, 63101

  • USA003

    Tyler, Texas, 75708

Other trials in United States

About this study

Official title: A Phase 2a, Single-Blind, Placebo-Controlled, Parallel-Group Study to Assess Safety, Tolerability, and Pharmacokinetics of Brensocatib Tablets in Adults With Cystic Fibrosis

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.

Conditions
Cystic Fibrosis
Being tested
Brensocatib, Placebo
Keywords
Cystic Fibrosis, Brensocatib
Medical subject headings
Cystic Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BrensocatibDrug

    Also called INS1007

    Oral tablet

  • PlaceboDrug

    Oral tablet

Study groups in NCT05090904
Study groupRoleWhat they receive
Brensocatib 10 mgExperimentalParticipants received brensocatib at a dose of 10 mg once per day for 28 days.
Receives: Drug: Brensocatib
Brensocatib 25 mgExperimentalParticipants received brensocatib at a dose of 25 mg once per day for 28 days.
Receives: Drug: Brensocatib
Brensocatib 40 mgExperimentalParticipants received brensocatib at a dose of 40 mg once per day for 28 days.
Receives: Drug: Brensocatib
PlaceboPlacebo comparatorParticipants received a placebo matching brensocatib once per day for 28 days.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Plasma Concentration (Cmax) of Brensocatib on Day 1

    Measured: Predose and 0.5, 1, 2, 4, 6, 8, and 24 hours postdose on Day 1

  2. Cmax of Brensocatib on Day 28

    Measured: Predose and at 0.5, 1, 2, 4, 6, 8, 24, and 168 hours postdose on Day 28

  3. Time to Maximum Plasma Concentration (Tmax) of Brensocatib on Day 1

    Measured: Predose and 0.5, 1, 2, 4, 6, 8, and 24 hours postdose on Day 1

  4. Tmax of Brensocatib on Day 28

    Measured: Predose and at 0.5, 1, 2, 4, 6, 8, 24, and 168 hours postdose on Day 28

  5. Area Under the Concentration-time Curve From Time 0 to 24 Hours Postdose (AUC0-24) of Brensocatib in Plasma on Day 1

    Measured: Predose and 0.5, 1, 2, 4, 6, 8, and 24 hours postdose on Day 1

  6. AUC0-24 of Brensocatib in Plasma on Day 28

    Measured: Predose and at 0.5, 1, 2, 4, 6, 8, and 24 hours postdose on Day 28

  7. Elimination Half-life (t1/2) of Brensocatib in Plasma on Day 28

    Measured: Predose and at 0.5, 1, 2, 4, 6, 8, 24, and 168 hours postdose on Day 28

  8. 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.

    Measured: Up to Day 56

Secondary outcomes (4)

  1. 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.

    Measured: 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

  2. 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.

    Measured: 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

  3. AUClast of Brensocatib in Plasma on Days 1 and 28

    Measured: 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

  4. 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.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2021
  2. Study start30 Nov 2021
  3. Primary completion1 Nov 2022
  4. Study completion1 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05090904
Sponsor's protocol ID
INS1007-211
Status last verified
Feb 2026
First submitted
14 Oct 2021
Last updated
12 Mar 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40753522

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Brensocatib in people with Cystic Fibrosis, run by Insmed Incorporated at 14 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Plasma Concentration (Cmax) of Brensocatib on Day 1 (time frame: Predose and 0.5, 1, 2, 4, 6, 8, and 24 hours postdose on Day 1). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05090904, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.

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