A Clinical Study to Test How Effective and Safe GLPG1690 is for Participants With Idiopathic Pulmonary Fibrosis (IPF) When Used Together With Standard of Care

Last updated: July 6, 2022
Sponsor: Galapagos NV
Overall Status: Terminated

Phase

3

Condition

Pulmonary Fibrosis

Idiopathic Pulmonary Fibrosis

Cystic Fibrosis

Treatment

N/A

Clinical Study ID

NCT03733444
GLPG1690-CL-304
2018-001406-29
  • Ages > 40
  • All Genders

Study Summary

The main purpose of this study was to see how GLPG1690 works together with the current standard treatment on your lung function and IPF disease in general. The study also investigated how well GLPG1690 is tolerated (for example if you get any side effects while on study drug).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female subject aged ≥40 years on the day of signing the Informed Consent Form (ICF).
  • A diagnosis of IPF within 5 years prior to the screening visit, as per applicableAmerican Thoracic Society (ATS)/European Respiratory Society (ERS)/JapaneseRespiratory Society (JRS)/Latin American Thoracic Association (ALAT) guidelines at thetime of diagnosis.
  • Chest high-resolution computed tomography (HRCT) historically performed within 12months prior to the screening visit and according to the minimum requirements for IPFdiagnosis by central review based on subject's HRCT only (if no lung biopsy (LB)available), or based on both HRCT and LB (with application of the different criteriain either situation). If an evaluable HRCT <12 months prior to screening is notavailable, an HRCT can be performed at screening to determine eligibility, accordingto the same requirements as the historical HRCT.
  • Subjects receiving local standard of care for the treatment of IPF, defined as eitherpirfenidone or nintedanib, at a stable dose for at least two months before screening,and during screening; or neither pirfenidone or nintedanib (for any reason). A stabledose is defined as the highest dose tolerated by the subject during those two months.
  • The extent of fibrotic changes is greater than the extent of emphysema on the mostrecent HRCT scan (investigator-determined).
  • Meeting all of the following criteria during the screening period: FVC ≥45% predictedof normal, Forced expiratory volume in 1 second (FEV1)/FVC ≥0.7, diffusing capacity ofthe lung for carbon monoxide (DLCO) corrected for Hb ≥30% predicted of normal.
  • Estimated minimum life expectancy of at least 30 months for non IPF related disease inthe opinion of the investigator.
  • Male subjects and female subjects of childbearing potential agree to use highlyeffective contraception/preventive exposure measures from the time of first dose ofinvestigational medicinal product (IMP) (for the male subject) or the signing of theICF (for the female subject), during the study, and until 90 days (male) or 30 days (female) after the last dose of IMP.
  • Able to walk at least 150 meters during the 6-Minute Walk Test (6MWT) at screeningVisit 1; without having a contraindication to perform the 6MWT or without a conditionputting the subject at risk of falling during the test (investigator's discretion).The use of a cane is allowed, the use of a stroller is not allowed at all for anycondition. At Visit 2, for the oxygen titration test, resting oxygen saturation (SpO2)should be ≥88% with maximum 6 L O2/minute; during the walk, SpO2 should be ≥83% with 6L O2/minute or ≥88% with 0, 2 or 4 L O2/minute.

Exclusion

Exclusion Criteria:

  • History of malignancy within the past 5 years (except for carcinoma in situ of theuterine cervix, basal cell carcinoma of the skin that has been treated with noevidence of recurrence, prostate cancer that has been medically managed through activesurveillance or watchful waiting, squamous cell carcinoma of the skin if fullyresected, and Ductal Carcinoma In Situ).
  • Clinically significant abnormalities detected on ECG of either rhythm or conduction, aQT interval corrected for heart rate using Fridericia's formula (QTcF) >450 ms, or aknown long QT syndrome. Patients with implantable cardiovascular devices (e.g.pacemaker) affecting the QT interval time may be enrolled in the study based uponinvestigator judgment following cardiologist consultation if deemed necessary, andonly after discussion with the medical monitor.
  • Acute IPF exacerbation within 6 months prior to screening and/or during the screeningperiod. The definition of an acute IPF exacerbation is as follows: Previous orconcurrent diagnosis of IPF; Acute worsening or development of dyspnea typically < 1month duration; Computed tomography with new bilateral ground-glass opacity and/orconsolidation superimposed on a background pattern consistent with usual interstitialpneumonia pattern and deterioration not fully explained by cardiac failure or fluidoverload.
  • Lower respiratory tract infection requiring treatment within 4 weeks prior toscreening and/or during the screening period.
  • Interstitial lung disease associated with known primary diseases (e.g. sarcoidosis andamyloidosis), exposures (e.g. radiation, silica, asbestos, and coal dust), or drugs (e.g. amiodarone).
  • Diagnosis of severe pulmonary hypertension (investigator determined).
  • Unstable cardiovascular, pulmonary (other than IPF), or other disease within 6 monthsprior to screening or during the screening period (e.g. acute coronary disease, heartfailure, and stroke).
  • Had gastric perforation within 3 months prior to screening or during screening, and/orunderwent major surgery within 3 months prior to screening, during screening or havemajor surgery planned during the study period.
  • History of nintedanib-related increase in ALT and/or AST of >5 x upper limit of thenormal range (ULN) and increased susceptibility to elevated LFT; moderate to severehepatic impairment (Child-Pugh B or C) and/or abnormal liver function test (LFT) atscreening, defined as aspartate aminotransferase (AST), and/or alanineaminotransferase (ALT), and/or total bilirubin ≥1.5 x upper limit of the normal range (ULN), and/or gamma glutamyl transferase (GGT) ≥3 x ULN. Retesting is allowed once forabnormal LFT.
  • Abnormal renal function defined as estimated creatinine clearance, calculatedaccording to Cockcroft-Gault calculation (CCr) <30 mL/min. Retesting is allowed once.
  • Use of any of the following therapies within 4 weeks prior to screening and during thescreening period, or planned during the study: warfarin, imatinib, ambrisentan,azathioprine, cyclophosphamide, cyclosporine A, bosentan, methotrexate, sildenafil (except for occasional use), prednisone at steady dose >10 mg/day or equivalent.

Study Design

Total Participants: 781
Study Start date:
November 05, 2018
Estimated Completion Date:
March 30, 2021

Connect with a study center

  • Centro Médico Dra de Salvo

    Buenos Aires, C1426ABP
    Argentina

    Site Not Available

  • Hospital Privado Centro Médico de Córdoba

    Córdoba, X5016KEH
    Argentina

    Site Not Available

  • CEMER Centro Médico de Enfermedades Respiratorias

    Florida, B1602DQD
    Argentina

    Site Not Available

  • Hospital Zonal Especializado de Agudos y Crónicos Dr. Antonio A. Cetrangolo

    Luján, B6700CNR
    Argentina

    Site Not Available

  • Instituto de Investigaciones Clínicas Mar Del Plata

    Mar Del Plata, B7600FZN
    Argentina

    Site Not Available

  • Fundacion Scherbovsky

    Mendoza, 5500
    Argentina

    Site Not Available

  • South Health Campus

    Calgary, T3M 1M4
    Canada

    Site Not Available

  • Hôtel Dieu Du Centre Hospitalier de L'université de Montréal

    Montréal, H2L 4M1
    Canada

    Site Not Available

  • McGill University Health Centre Research Institute

    Montréal, QC H3S 1Y9
    Canada

    Site Not Available

  • Institut Universitaire de Cardiologie et de Pneumologie

    Québec, G1V 4G5
    Canada

    Site Not Available

  • Toronto General Hospital

    Toronto, M5G 2N2
    Canada

    Site Not Available

  • Pacific Lung Research Center

    Vancouver, V6Z 1Y6
    Canada

    Site Not Available

  • Vancouver General Hospital

    Vancouver, V5Z 1M9
    Canada

    Site Not Available

  • Dr Anil Dhar Professional Medicine Corporation

    Windsor, N8W1L9
    Canada

    Site Not Available

  • Hôpital Nord AP-HM

    Marseille, 13915
    France

    Site Not Available

  • Centre Hospitalier Regional Universitaire Montpellier

    Montpellier, 34295
    France

    Site Not Available

  • Groupe Hospitalier Bichat Claude Bernard

    Paris, 75018
    France

    Site Not Available

  • CHU de Reims

    Reims, 51092
    France

    Site Not Available

  • Ruhrlandklinik

    Essen, 45239
    Germany

    Site Not Available

  • Praxis Dr. med. Claus Keller

    Frankfurt, 60389
    Germany

    Site Not Available

  • Universitätsmedizin Greifswald Klinik und Poliklinik für Innere Medizin B

    Greifswald, 17475
    Germany

    Site Not Available

  • Pneumologisches Forschungsinstitut

    Großhansdorf, 22927
    Germany

    Site Not Available

  • Lungenfachklinik Immenhausen

    Immenhausen, 34376
    Germany

    Site Not Available

  • Kliniken der Stadt Koln GmbH

    Köln, 51109
    Germany

    Site Not Available

  • Krankenhaus Bethanien - Klinik für Pneumologie und Allergologie

    Solingen, 42699
    Germany

    Site Not Available

  • Semmelweis Egyetem

    Budapest, 1125
    Hungary

    Site Not Available

  • Veszprem Megyei Tudogyogyintezet

    Farkasgyepű, 8582
    Hungary

    Site Not Available

  • Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktató Kórház

    Miskolc, 3529
    Hungary

    Site Not Available

  • Tüdőgyógyintézet Törökbálint

    Törökbálint, 2045
    Hungary

    Site Not Available

  • Barzilai Medical Center

    Ashkelon, 78278
    Israel

    Site Not Available

  • Lady Davis Carmel Medical Center

    Haifa, 34362
    Israel

    Site Not Available

  • Hadassah University Hospital Ein Kerem

    Jerusalem, 91120
    Israel

    Site Not Available

  • Meir Medical Center

    Kfar Saba, 44281
    Israel

    Site Not Available

  • Rabin Medical Center - PPDS

    Petah tikva, 49100
    Israel

    Site Not Available

  • Kaplan Medical Center

    Reẖovot, 7661041
    Israel

    Site Not Available

  • Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele

    Catania, Sicilia 95123
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi

    Ancona, 60020
    Italy

    Site Not Available

  • Presidio Ospedaliero GB Morgagni L Pierantoni

    Forlì, 47121
    Italy

    Site Not Available

  • Ospedale S. Giuseppe Multimedica

    Milano, 20123
    Italy

    Site Not Available

  • Università Cattolica Del S Cuore

    Roma, 00168
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Senese

    Siena, 53100
    Italy

    Site Not Available

  • National Hospital Organization Ibarakihigashi National Hospital

    Naka, Ibaraki 319-1113
    Japan

    Site Not Available

  • Tenryu Hospital

    Hamamatsu, Shizuoka 434-8511
    Japan

    Site Not Available

  • Juntendo University Hospital

    Bunkyo, 113-8431
    Japan

    Site Not Available

  • Fukuoka University Hospital

    Fukuoka, 814-0180
    Japan

    Site Not Available

  • National Hospital Organization Kyushu Medical Center

    Fukuoka, 810-8563
    Japan

    Site Not Available

  • NHO Okinawa Hospital

    Ginowan, 901-2214
    Japan

    Site Not Available

  • Hamamatsu University School of Medicine

    Hamamatsu, 431-3192
    Japan

    Site Not Available

  • National Hospital Organization Himeji Medical Center

    Himeji, 670-8520
    Japan

    Site Not Available

  • Hiroshima Prefectural Hospital

    Hiroshima, 734-8530
    Japan

    Site Not Available

  • Kobe City Medical Center General Hospital

    Hyōgo, 650-0047
    Japan

    Site Not Available

  • Saiseikai Kumamoto Hospital

    Kumamoto, 861-4101
    Japan

    Site Not Available

  • Nagasaki University Hospital

    Nagasaki, 852-8102
    Japan

    Site Not Available

  • Nagoya University Hospital

    Nagoya, 466-8560
    Japan

    Site Not Available

  • Japanese Red Cross Okayama Hospital

    Okayama, 700-8607
    Japan

    Site Not Available

  • National Hospital Organization Kinki-Chuo Chest Medical Center

    Sakai, 591-8555
    Japan

    Site Not Available

  • Tohoku Medical and Pharmaceutical Hospital

    Sendai, 983-8512
    Japan

    Site Not Available

  • Tosei General Hospital

    Seto, 489-8642
    Japan

    Site Not Available

  • Tokyo Medical University Hospital

    Shinjuku-Ku, 160-0023
    Japan

    Site Not Available

  • Tokushima University Hospital

    Tokushima, 770-8503
    Japan

    Site Not Available

  • Center Hospital of the National Center for Global Health and Medicine

    Tokyo, 162-8655
    Japan

    Site Not Available

  • Kanagawa Cardiovascular and Respiratory Center

    Yokohama, 236-0051
    Japan

    Site Not Available

  • Soon Chun Hyang University Hospital Bucheon

    Bucheon, Gyeonggi-do 420-767
    Korea, Republic of

    Site Not Available

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do 463-707
    Korea, Republic of

    Site Not Available

  • Gachon University Gil Medical Center

    Incheon, 405760
    Korea, Republic of

    Site Not Available

  • Asan Medical Center - PPDS

    Seoul, 05505
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul, 135-170
    Korea, Republic of

    Site Not Available

  • Soon Chun Hyang University Hospital Seoul

    Seoul, 140-743
    Korea, Republic of

    Site Not Available

  • Instituto Nacional De Enfermedades (INER)

    Ciudad de mexico, 14080
    Mexico

    Site Not Available

  • Centro de Investigación Medico Biologica y de Terapia Avanzada S.C.

    Guadalajara, 44130
    Mexico

    Site Not Available

  • Hospital Universitatorio Dr. Jose Eleuterio González

    Monterrey, 64460
    Mexico

    Site Not Available

  • Unidad de Investigación Clínica En Medicina SC

    Monterrey, 64718
    Mexico

    Site Not Available

  • OLVG locatie Oost

    Amsterdam, 1091 AC
    Netherlands

    Site Not Available

  • VU Medisch Centrum

    Amsterdam, 1081 HV
    Netherlands

    Site Not Available

  • Martini Ziekenhuis

    Groningen, 9700 RM
    Netherlands

    Site Not Available

  • Zuyderland Medisch Centrum

    Heerlen, 6419 PC
    Netherlands

    Site Not Available

  • St. Antonius Ziekenhuis

    Nieuwegein, 3425 CM
    Netherlands

    Site Not Available

  • Erasmus MC

    Rotterdam, 3015 GD
    Netherlands

    Site Not Available

  • Greenlane Clinical Centre

    Auckland, 1051
    New Zealand

    Site Not Available

  • NZ Respiratory & Sleep Institute

    Auckland, 1149
    New Zealand

    Site Not Available

  • Christchurch Hospital

    Christchurch, 8011
    New Zealand

    Site Not Available

  • Waikato Hospital

    Hamilton, 3204
    New Zealand

    Site Not Available

  • Centrum Medycyny Oddechowej Mroz sp. j.

    Białystok, 15-044
    Poland

    Site Not Available

  • Uniwersyteckie Centrum Kliniczne - PPDS

    Gdańsk, 80-952
    Poland

    Site Not Available

  • PULMAG Arkadiusz Brodowski, Grzegorz Gasior S. C.

    Katowice, 40-753
    Poland

    Site Not Available

  • GRAŻYNA JASIENIAK-PINIS ATOPIA Niepubliczny Zakład Opieki Zdrowotnej Poradnie Specjalistyczne

    Kraków, 31-159
    Poland

    Site Not Available

  • SP ZOZ Szpital Uniwersytecki w Krakowie

    Kraków, 31-153
    Poland

    Site Not Available

  • ETG Lublin

    Lublin, 20-314
    Poland

    Site Not Available

  • ETG Warszawa

    Warszawa, 02-777
    Poland

    Site Not Available

  • SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im Norberta Barlickiego Uniwersytetu Medycznego w Lodzi

    Łódź, 90-153
    Poland

    Site Not Available

  • Dr Ismail Abdullah Private Practice

    Cape Town, 7764
    South Africa

    Site Not Available

  • Tygerberg Hospital

    Cape Town, 7505
    South Africa

    Site Not Available

  • University of Cape Town Lung Institute (UCTLI)

    Cape Town, 7700
    South Africa

    Site Not Available

  • Ethekwini Hospital

    Durban, 4017
    South Africa

    Site Not Available

  • Gateway Private Hospital

    Durban, 4091
    South Africa

    Site Not Available

  • Milpark Hospital

    Johannesburg, 2193
    South Africa

    Site Not Available

  • University of Alabama at Birmingham

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • Arizona Pulmonary Specialists

    Phoenix, Arizona 85012
    United States

    Site Not Available

  • University of Arizona College of Medicine

    Tucson, Arizona 85724
    United States

    Site Not Available

  • Cedars Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • Keck School of Medicine of USC

    Los Angeles, California 90033
    United States

    Site Not Available

  • UC Davis Medical Center

    Sacramento, California 95816
    United States

    Site Not Available

  • University of California, San Francisco Medical Center

    San Francisco, California 94143
    United States

    Site Not Available

  • St. Francis Medical Institute

    Clearwater, Florida 33765
    United States

    Site Not Available

  • University of Miami

    Miami, Florida 33136
    United States

    Site Not Available

  • Renstar Medical Research

    Ocala, Florida 34470
    United States

    Site Not Available

  • Central Florida Pulmonary Group PA

    Orlando, Florida 32803
    United States

    Site Not Available

  • Emory University

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Piedmont Healthcare

    Atlanta, Georgia 30309
    United States

    Site Not Available

  • University of Chicago Medical Center

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Loyola University Medical Center

    Maywood, Illinois 60153
    United States

    Site Not Available

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Brigham and Womens Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • University of Michigan Health System (UMHS)

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Spectrum Health Medical Group

    Grand Rapids, Michigan 49546
    United States

    Site Not Available

  • University of Minnesota Medical Center

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Cardio Pulmonary Associates

    Chesterfield, Missouri 63017
    United States

    Site Not Available

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire 03765
    United States

    Site Not Available

  • Atlantic Respiratory Institute

    Summit, New Jersey 07901
    United States

    Site Not Available

  • Lovelace Scientific Resources Inc

    Albuquerque, New Mexico 87108
    United States

    Site Not Available

  • Albany Medical Center

    Albany, New York 12208
    United States

    Site Not Available

  • Columbia University Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Ohio State University

    Columbus, Ohio 43203
    United States

    Site Not Available

  • Mercy Health - St. Vincent Medical Center

    Toledo, Ohio 43608
    United States

    Site Not Available

  • Temple Lung Center

    Philadelphia, Pennsylvania 19140
    United States

    Site Not Available

  • Thomas Jefferson University

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Medical University of South Carolina - PPDS

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • University of Vermont

    Burlington, Vermont 05401
    United States

    Site Not Available

  • Inova Fairfax Hospital

    Falls Church, Virginia 22042
    United States

    Site Not Available

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