Assessment of INS1007 in Participants With Non-Cystic Fibrosis Bronchiectasis
NCT ID: NCT03218917
Last Updated: 2023-03-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
256 participants
INTERVENTIONAL
2017-10-31
2019-12-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Brensocatib 10 mg
Participants received brensocatib 10 mg once daily (QD) before breakfast, for 24 weeks.
Brensocatib 10 mg
Administered once per day for 24 weeks
Brensocatib 25 mg
Participants received brensocatib 25 mg QD before breakfast, for 24 weeks.
Brensocatib 25 mg
Administered once per day for 24 weeks
Placebo
Participants received the matching placebo QD before breakfast, for 24 weeks.
Placebo
Administered once per day for 24 weeks
Interventions
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Brensocatib 10 mg
Administered once per day for 24 weeks
Brensocatib 25 mg
Administered once per day for 24 weeks
Placebo
Administered once per day for 24 weeks
Eligibility Criteria
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Inclusion Criteria
2. Are current sputum producers with a history of chronic expectoration and able to provide a sputum sample during Screening
3. Have at least 2 documented pulmonary exacerbations in the past 12 months before Screening
Exclusion Criteria
2. Have bronchiectasis due to cystic fibrosis (CF), hypogammaglobulinemia, common variable immunodeficiency, or alpha1-antitrypsin deficiency
3. Are current smokers
4. Are currently being treated for a nontuberculous mycobacterial lung infection, allergic bronchopulmonary aspergillosis, or tuberculosis
5. Have any acute infections, (including respiratory infections)
18 Years
85 Years
ALL
No
Sponsors
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Insmed Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Carlos Fernandez, MD
Role: STUDY_DIRECTOR
Insmed Incorporated
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Phoenix Medical Group
Peoria, Arizona, United States
NewportNativeMD
Newport Beach, California, United States
Palmtree Clinical Research
Palm Springs, California, United States
UC Davis Medical Center
Sacramento, California, United States
Stanford University Medical Center
Stanford, California, United States
National Jewish Heath
Denver, Colorado, United States
UConn Health Center
Farmington, Connecticut, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Clinical Research Specialists, LLC
Celebration, Florida, United States
St. Francis Medical Institute
Clearwater, Florida, United States
University of Florida
Gainesville, Florida, United States
University of Miami Miller School of Medicine
Miami, Florida, United States
San Marcus Research Clinic, Inc.
Miami Lakes, Florida, United States
Sarasota Memorial Hospital Clinical Research Center
Sarasota, Florida, United States
The Emory Clinic, Pulmonology
Atlanta, Georgia, United States
University of Chicago
Chicago, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
LSU Health Sciences Center
New Orleans, Louisiana, United States
Johns Hopkins University, Division of Pulmonary and Critical Care Medicine
Baltimore, Maryland, United States
Pulmonary and Critical Care Associates of Baltimore
Towson, Maryland, United States
Mid Atlantic Pulmonary & Research Center
Westminster, Maryland, United States
Michigan Medicine
Ann Arbor, Michigan, United States
NYU Pulmonary & Critical Care Associates
New York, New York, United States
Columbia University Medical Center/ New York Presbyterian Hospital
New York, New York, United States
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Novant Health Pulmonary Medicine South
Charlotte, North Carolina, United States
Southeastern Research Center
Winston-Salem, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
SMS Clinical Research, LLC
Mesquite, Texas, United States
The University of Texas Health Science at Tyler
Tyler, Texas, United States
MultiCare Institute for Research & Innovation
Tacoma, Washington, United States
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Mater Misericordia Medical Centre
Brisbane, Queensland, Australia
Gallipoli Medical Research Foundation
Brisbane, Queensland, Australia
Metro North Hospital and Health Service (The Prince Charles Hospital)
Chermside, Queensland, Australia
Respiratory Clinical Trials Unit, Royal Adelaide Hospital
Adelaide, South Australia, Australia
Respiratory Clinical Trials PTY LTD
Kent Town, South Australia, Australia
Box Hill Hospital, Eastern Clinical Research Unit
Box Hill, Victoria, Australia
Alfred Hospital
Melbourne, Victoria, Australia
Institute for Respiratory Health
Nedlands, Western Australia, Australia
UZ Leuven
Leuven, Vlaams Brabant, Belgium
Medical Center ReSpiro Ltd (Kiselov)
Razgrad, Momina, Bulgaria
Medical Center UNIMED
Plovdiv, , Bulgaria
MHAT "Dr IvanSeliminski"-Sliven
Sliven, , Bulgaria
Cardioart Medical Center
Stara Zagora, , Bulgaria
Hvidovre Hospital
Hvidovre, Capital Region, Denmark
Aarhus University Hospital
Aarhus, , Denmark
Sjællands Universitetshospital, Roskilde
Roskilde, , Denmark
Krankenhaus Donaustauf
Donaustauf, Bavaria, Germany
Klinikum der Universität München Medizinische Klinik V Pneumologie / Mukoviszidose-Zentrum für Erwachsene
Munich, Bavaria, Germany
Klinikum Nuernberg
Nuremberg, Bavaria, Germany
Universitätsklinikum Frankfurt
Frankfurt am Main, Hesse, Germany
IKF Pneumologie Frankfurt
Frankfurt am Main, Hesse, Germany
Ruhrlandklinik Essen, University Essen
Essen, North Rhine-Westphalia, Germany
Forschungszentrum Borstel
Borstel, Schleswig-Holstein, Germany
Universitätsklinikum Jena
Jena, Thuringia, Germany
Research Center for Medical Studies (RCMS)
Berlin, , Germany
Städt. Klinikum München GmbH, Bogenhausen
München, , Germany
University of Milan, IRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico
Milan, Lombardy, Italy
Ospedale San Gerardo
Monza, Monza E Brianza, Italy
University Hospital of Pisa
Pisa, Via Paradisa 2, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, , Italy
ICS Maugeri spa SB, IRCSS Telese
Telese Terme, , Italy
Noordwest Ziekenhuis Group
Alkmaar, , Netherlands
Amphia Longresearch Astma/COPD Uni 52/5e etage
Breda, , Netherlands
RadboudUMC, location Dekkerswald
Nijmegen, , Netherlands
Zuyderland MC
Sittard, , Netherlands
P3 Research
Tauranga, BOP, New Zealand
P3 Research (Hawke's Bay)
Hastings, Hawkes Bay, New Zealand
Southern District health Board/Dunedin Hospital
Dunedin, Otago, New Zealand
Waikato District Health Board
Hamilton, Waikato Region, New Zealand
Auckland District Health Board, Greenlane clinical Centre
Auckland, , New Zealand
Centrum Badan Klinicznych, Piotr Napora Lekarze i Spolka Partnerska, Osrodek Badan Wczesnej Fazy
Wroclaw, Lower Silesian Voivodeship, Poland
Grażyna Jasieniak Pinis Niepubliczny Zakład Opieki Zdrowotnej Atopia
Krakow, , Poland
NZOZ Krak-Medyk Sp. z o.o
Krakow, , Poland
Medical University of Lodz Poland
Lodz, , Poland
Gabinet Lekarski Pediatryczno-Alergologiczny Zenon Bukowczan
Sucha Beskidzka, , Poland
Singapore General Hospital
Singapore, , Singapore
Changi General Hospital
Singapore, , Singapore
Inha University Hospital
Incheon, Jung-gu, South Korea
Gachon University Gil Medical Center
Incheon, Namdong-gu, South Korea
Chonnam National University Hospital
Gwangju, , South Korea
The Catholic University of Korea Incheon St. Mary's Hospital
Incheon, , South Korea
The Catholic University of Korea, St. Paul's Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Konkuk University Medical Center
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, , South Korea
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Universitari de Bellvitge
Barcelona, , Spain
Hospital Universitari de Girona Dr. Josep Trueta
Girona, , Spain
Hospital Universiatrio y politecnico La Fe
Valencia, , Spain
NHS Tayside
Dundee, Angus, United Kingdom
Papworth Hospital NHS Foundation Trust
Cambridge, Cambridgeshire, United Kingdom
Blackpool Teaching Hospitals NHS Foundation Trust
Blackpool, Lancashire, United Kingdom
Liverpool Heart and Chest Hospital NHS Foundation Trust
Liverpool, Merseyside, United Kingdom
NHS Lothian
Edinburgh, Scotland, United Kingdom
Ashford and St Peter's Hospitals NHS Foundation Trust
Chertsey, Surrey, United Kingdom
The Royal Wolverhampton NHS Trust
Wolverhampton, West Midlands, United Kingdom
Royal Brompton & Harefield NHS Foundation Trust
London, , United Kingdom
Pennine Acute Hospitals NHS Trust
Manchester, , United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, , United Kingdom
Countries
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References
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Johnson ED, Long MB, Perea L, Shih VH, Fernandez C, Teper A, Cipolla D, McIntosh E, Galloway R, Eke Z, Shuttleworth M, Hull R, Spinou A, De Soyza A, Ringshausen FC, Goeminne P, Lorent N, Haworth C, Loebinger MR, Blasi F, Shteinberg M, Aliberti S, Polverino E, Sibila O, Shoemark A, Mange K, Huang JTJ, Stobo J, Chalmers JD. Broad Immunomodulatory Effects of the Dipeptidyl-peptidase-1 Inhibitor Brensocatib in Bronchiectasis: Data from the Phase 2, Double-Blind, Placebo-controlled WILLOW Trial. Am J Respir Crit Care Med. 2025 Feb 12. doi: 10.1164/rccm.202408-1545OC. Online ahead of print.
Basso J, Chen KJ, Zhou Y, Mark L, LaSala D, Dorfman A, Atalla M, Chun D, Viramontes V, Chang C, Leifer F, McDonald PP, Cipolla DC. The pharmacokinetic profile of brensocatib and its effect on pharmacodynamic biomarkers including NE, PR3, and CatG in various rodent species. Front Pharmacol. 2023 Jul 19;14:1208780. doi: 10.3389/fphar.2023.1208780. eCollection 2023.
Cipolla D, Zhang J, Korkmaz B, Chalmers JD, Basso J, Lasala D, Fernandez C, Teper A, Mange KC, Perkins WR, Sullivan EJ. Dipeptidyl peptidase-1 inhibition with brensocatib reduces the activity of all major neutrophil serine proteases in patients with bronchiectasis: results from the WILLOW trial. Respir Res. 2023 May 17;24(1):133. doi: 10.1186/s12931-023-02444-z.
Chalmers JD, Haworth CS, Metersky ML, Loebinger MR, Blasi F, Sibila O, O'Donnell AE, Sullivan EJ, Mange KC, Fernandez C, Zou J, Daley CL; WILLOW Investigators. Phase 2 Trial of the DPP-1 Inhibitor Brensocatib in Bronchiectasis. N Engl J Med. 2020 Nov 26;383(22):2127-2137. doi: 10.1056/NEJMoa2021713. Epub 2020 Sep 7.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2017-002533-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
INS1007-201
Identifier Type: -
Identifier Source: org_study_id
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