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

Last updated: October 31, 2023
Sponsor: Insmed Incorporated
Overall Status: Completed

Phase

2

Condition

Scar Tissue

Cystic Fibrosis

Lung Disease

Treatment

Brensocatib

Placebo

Clinical Study ID

NCT05090904
INS1007-211
  • Ages > 18
  • All Genders

Study 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.

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:
  1. Percent predicted forced expiratory volume in 1 second (ppFEV1) between 40% to 90% (inclusive) at Screening Visit and at Baseline.
  2. 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.
  1. 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.
  2. 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:
  1. Currently treated by a dentist for this condition or
  2. 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

Total Participants: 29
Treatment Group(s): 2
Primary Treatment: Brensocatib
Phase: 2
Study Start date:
November 30, 2021
Estimated Completion Date:
November 01, 2022

Connect with a study center

  • USA021

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • USA012

    La Jolla, California 92037-1300
    United States

    Site Not Available

  • USA019

    Palo Alto, California 94304-1524
    United States

    Site Not Available

  • USA013

    Sacramento, California 95817-2201
    United States

    Site Not Available

  • USA024

    Santa Barbara, California 93102
    United States

    Site Not Available

  • USA001

    Gainesville, Florida 32610-0001
    United States

    Site Not Available

  • USA005

    Orlando, Florida 32810
    United States

    Site Not Available

  • USA020

    Atlanta, Georgia 30322-1014
    United States

    Site Not Available

  • USA016

    Augusta, Georgia 30912-0004
    United States

    Site Not Available

  • USA025

    Glenview, Illinois 60025-7645
    United States

    Site Not Available

  • USA025

    Northfield, Illinois 60093
    United States

    Site Not Available

  • USA011

    Boston, Massachusetts 02115-5724
    United States

    Site Not Available

  • USA023

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • USA002

    Saint Louis, Missouri 63101
    United States

    Site Not Available

  • USA022

    New York, New York 10032-3720
    United States

    Site Not Available

  • USA006

    Cleveland, Ohio 44195-0001
    United States

    Site Not Available

  • USA008

    Cleveland, Ohio 44106-1716
    United States

    Site Not Available

  • USA007

    Columbus, Ohio 43205
    United States

    Site Not Available

  • USA018

    Portland, Oregon 97239-3011
    United States

    Site Not Available

  • USA014

    Pittsburgh, Pennsylvania 15224-1334
    United States

    Site Not Available

  • USA009

    Charleston, South Carolina 29425-8900
    United States

    Site Not Available

  • USA017

    Nashville, Tennessee 37232-0028
    United States

    Site Not Available

  • USA004

    Dallas, Texas 75390-7208
    United States

    Site Not Available

  • USA010

    Houston, Texas 77030
    United States

    Site Not Available

  • USA003

    Tyler, Texas 75708
    United States

    Site Not Available

  • USA015

    Salt Lake City, Utah 84108-1287
    United States

    Site Not Available

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