A Clinical Study to Test How Effective and Safe GLPG1690 is for Subjects 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

Lung Injury

Scar Tissue

Cystic Fibrosis

Treatment

N/A

Clinical Study ID

NCT03711162
GLPG1690-CL-303
2018-001405-87
  • Ages > 40
  • All Genders

Study Summary

The main purpose of this study was to see how GLPG1690 works together with your 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 got 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: 525
Study Start date:
November 28, 2018
Estimated Completion Date:
March 30, 2021

Connect with a study center

  • Royal Adelaide Hospital

    Adelaide, 5000
    Australia

    Site Not Available

  • Flinders Medical Centre

    Bedford Park, 5042
    Australia

    Site Not Available

  • Box Hill Hospital

    Box Hill, VIC 3128
    Australia

    Site Not Available

  • Corte Royal Prince Alfred Hospital

    Camperdown, NSW 2050
    Australia

    Site Not Available

  • Lung Research Queensland

    Chermside, QLD 4060
    Australia

    Site Not Available

  • Concord Repatriation General Hospital

    Concord, NSW 2139
    Australia

    Site Not Available

  • St Vincent's Hospital Sydney

    Darlinghurst, NSW 2010
    Australia

    Site Not Available

  • Austin Health

    Heidelberg, 3084
    Australia

    Site Not Available

  • Respiratory Clinical Trials Pty Ltd

    Kent Town, SA 5067
    Australia

    Site Not Available

  • The Alfred Hospital

    Melbourne, VIC 3004
    Australia

    Site Not Available

  • ZNA Middelheim

    Antwerp, 2020
    Belgium

    Site Not Available

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200
    Belgium

    Site Not Available

  • Hôpital Erasme

    Brussels, 1070
    Belgium

    Site Not Available

  • UZ Leuven

    Leuven, 3000
    Belgium

    Site Not Available

  • CHU UCL Namur asbl - Site Godinne

    Yvoir, 5530
    Belgium

    Site Not Available

  • Irmandade Da Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, 90035-074
    Brazil

    Site Not Available

  • Faculdade de Medicina Do ABC

    Santo André, 09060-870
    Brazil

    Site Not Available

  • Hospital Clínico Regional de Concepción Dr Guillermo Grant Benavente

    Concepción, 4070038
    Chile

    Site Not Available

  • Centro de Investigación Curico

    Curicó, 3341643
    Chile

    Site Not Available

  • Centro Respiratorio Integral LTDA. (CENRESIN)

    Quillota, 2260000
    Chile

    Site Not Available

  • Centro de Investigaciones Medicas Respiratorias CIMER

    Santiago, 7500692
    Chile

    Site Not Available

  • Hospital Dr Sotero Del Rio

    Santiago, 8207257
    Chile

    Site Not Available

  • Instituto Nacional Torax

    Santiago, 7500691
    Chile

    Site Not Available

  • Centro de Investigacion del Maule

    Talca, 3465584
    Chile

    Site Not Available

  • Hospital Carlos Van Buren

    Valparaíso, 2352499
    Chile

    Site Not Available

  • CINVEC- Estudos Clínicos Quinta Región Limitada

    Viña Del Mar, 2520024
    Chile

    Site Not Available

  • Fakultni nemocnice Brno

    Brno, 62500
    Czechia

    Site Not Available

  • Fakultni nemocnice Ostrava

    Ostrava, 708 52
    Czechia

    Site Not Available

  • Nemocnice Na Bulovce

    Praha, 180 81
    Czechia

    Site Not Available

  • Thomayerova nemocnice

    Praha, 14059
    Czechia

    Site Not Available

  • Aarhus Universitetshospital

    Aarhus, 8200
    Denmark

    Site Not Available

  • Gentofte Hospital

    Hellerup, 2900
    Denmark

    Site Not Available

  • Odense Universitetshospital

    Odense, 5000
    Denmark

    Site Not Available

  • Zentralklinik Bad Berka GmbH

    Bad Berka, 99437
    Germany

    Site Not Available

  • Evangelische Lungenklinik

    Berlin, 13125
    Germany

    Site Not Available

  • Fachkrankenhaus Coswig

    Coswig, 01640
    Germany

    Site Not Available

  • Medizinische Hochschule Hannover

    Hannover, 30625
    Germany

    Site Not Available

  • Thorax Klinik

    Heidelberg, 69126
    Germany

    Site Not Available

  • Universitatsklinikum Leipzig

    Leipzig, 04103
    Germany

    Site Not Available

  • Klinikum Rosenheim

    Rosenheim, 83022
    Germany

    Site Not Available

  • Attikon University General Hospital

    Athens, 12464
    Greece

    Site Not Available

  • Sotiria Chest Hospital of Athens

    Athens, 11527
    Greece

    Site Not Available

  • University General Hospital of Heraklion

    Iraklio, 71110
    Greece

    Site Not Available

  • University General Hospital of Larissa

    Larissa, 41110
    Greece

    Site Not Available

  • Georgios Papanikolaou General Hospital of Thessaloniki

    Thessaloníki, 57010
    Greece

    Site Not Available

  • Tenryu Hospital

    Hamamatsu, 434-8511
    Japan

    Site Not Available

  • Saiseikai Kumamoto Hospital

    Kumamoto, 861-4193
    Japan

    Site Not Available

  • National Hospital Organization Kinki-Chuo Chest Medical Center

    Sakai, 591-8555
    Japan

    Site Not Available

  • Tosei General Hospital

    Seto, 489-0065
    Japan

    Site Not Available

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

    Tokyo, 162-0052
    Japan

    Site Not Available

  • National Hospital Organization Kyushu Medical Center

    Tokyo, 810-8563
    Japan

    Site Not Available

  • Kanagawa Cardiovascular and Respiratory Center

    Yokohama, 236-0051
    Japan

    Site Not Available

  • Hospital Chancay y Servicios Basicos de Salud

    Chancay, 15131
    Peru

    Site Not Available

  • Hospital Nacional Guillermo Almenara Irigoyen ESSALUD

    Lima,
    Peru

    Site Not Available

  • Clinica Internacional - PPDS

    Lima Cercado,
    Peru

    Site Not Available

  • Clinica Ricardo Palma - PPDS

    San Isidro,
    Peru

    Site Not Available

  • Clinica Providencia (Inverconsult Sociedad Anonima)

    San Miguel,
    Peru

    Site Not Available

  • Clinica San Pablo

    Santiago De Surco,
    Peru

    Site Not Available

  • CHUVI - H.U. Alvaro Cunquerio

    Vigo, Pontevedra 36312
    Spain

    Site Not Available

  • Hospital Clinical de Barcelona

    Barcelona, 03036
    Spain

    Site Not Available

  • Hospital Universitario de Bellvitge, Hospitalet De Llobregat

    Barcelona, 08097
    Spain

    Site Not Available

  • Hospital Clinico San Carlos

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Universitario de La Princesa

    Madrid, 28006
    Spain

    Site Not Available

  • Clinica Universidad Navarra

    Pamplona, 31008
    Spain

    Site Not Available

  • Hospital Universitario Marques de Valdecilla

    Santander, 39008
    Spain

    Site Not Available

  • Consorcio Hospital General Universitario de Valencia

    Valencia, 46014
    Spain

    Site Not Available

  • Kaohsiung Medical University Hospital

    Kaohsiung City, 807
    Taiwan

    Site Not Available

  • Far Eastern Memorial Hospital

    New Taipei City, 220
    Taiwan

    Site Not Available

  • Taipei Medical University Shuang Ho Hospital

    New Taipei City, 23561
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei, 10002
    Taiwan

    Site Not Available

  • Süreyyapaşa Göğüs Hastalıkları Ve Göğüs Cerrahisi Eğitim Ve Araştırma Hastanesi

    Istanbul, 34854
    Turkey

    Site Not Available

  • Mersin Üniversitesi Tıp Fakültesi Hastanesi Göğüs Hastalıkları Polikinliği

    Mersin, 33169
    Turkey

    Site Not Available

  • Ege Universitesi Tıp Fakultesi Hastanesi Gögus Hastalıkları Anabilim Dalı

    İzmir, 35100
    Turkey

    Site Not Available

  • Uludag Universitesi Tıp Fakultesi Hastanesi Gögüs Hastalıkları Anabilim Dalı

    İzmir, 35100
    Turkey

    Site Not Available

  • Birmingham Heartlands Hospital

    Birmingham, B9 5SS
    United Kingdom

    Site Not Available

  • Southmead Hospital

    Bristol, BS10 5NB
    United Kingdom

    Site Not Available

  • Papworth Hospital

    Cambridge, CB233RE
    United Kingdom

    Site Not Available

  • Castle Hill Hospital

    Cottingham, HU16 5JQ
    United Kingdom

    Site Not Available

  • Royal Devon and Exeter Hospital NHS Trust

    Exeter, EX2 5DW
    United Kingdom

    Site Not Available

  • Aintree University Hospital NHS Foundation Trust

    Liverpool, L9 7AL
    United Kingdom

    Site Not Available

  • Royal Brompton Hospital

    London, SW3 6NP
    United Kingdom

    Site Not Available

  • Wythenshawe Hospital - PPDS

    Manchester, M23 9LT
    United Kingdom

    Site Not Available

  • The Newcastle Upon Tyne Hospitals NHS Foundation Trust

    Newcastle, NE14LP
    United Kingdom

    Site Not Available

  • Nottingham City Hospital

    Nottingham, NG5 1PB
    United Kingdom

    Site Not Available

  • Northern General Hospital

    Sheffield, S5 7AU
    United Kingdom

    Site Not Available

  • Pulmonary Associates

    Phoenix, Arizona 85006
    United States

    Site Not Available

  • Mayo Clinic Arizona - PPDS

    Scottsdale, Arizona 85259
    United States

    Site Not Available

  • Atria Clinical Research - BTC - PPDS

    Little Rock, Arkansas 72209
    United States

    Site Not Available

  • David Geffen School of Medicine at UCLA

    Los Angeles, California 90095
    United States

    Site Not Available

  • Respire Research

    Palm Springs, California 92262
    United States

    Site Not Available

  • University of California San Diego

    San Diego, California 92037
    United States

    Site Not Available

  • Stanford University Medical Center

    Stanford, California 94305
    United States

    Site Not Available

  • University of Colorado

    Aurora, Colorado 80045
    United States

    Site Not Available

  • National Jewish Health

    Denver, Colorado 80206
    United States

    Site Not Available

  • Western Connecticut Medical Group

    Danbury, Connecticut 06810
    United States

    Site Not Available

  • Yale University School of Medicine

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • MedStar Georgetown University Hospital

    Washington, District of Columbia 20007
    United States

    Site Not Available

  • PAB Clinical Research - ClinEdge - PPDS

    Brandon, Florida 33511
    United States

    Site Not Available

  • St. Francis Medical Institute - BTC - PPDS

    Clearwater, Florida 33765
    United States

    Site Not Available

  • North Florida/South Georgia Veterans Health System-NAVREF-PPDS

    Gainesville, Florida 32608
    United States

    Site Not Available

  • University of Florida

    Gainesville, Florida 32610
    United States

    Site Not Available

  • Advanced Pulmonary Research Institute

    Loxahatchee Groves, Florida 33470
    United States

    Site Not Available

  • Northwestern Memorial Hospital

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Pulmonary and Infections Disease Associates

    Council Bluffs, Iowa 51503
    United States

    Site Not Available

  • University of Louisville

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Tulane Medical Center

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • University of Maryland Medical Center

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Caritas St. Elizabeth's Medical Center

    Boston, Massachusetts 02135
    United States

    Site Not Available

  • Massachusetts General Hospital, Division of Pulmonary and Critical Care Medicine

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Henry Ford Health System

    Dearborn, Michigan 48124
    United States

    Site Not Available

  • Minnesota Lung Center

    Minneapolis, Minnesota 55407
    United States

    Site Not Available

  • Mayo Clinic - PPDS

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Creighton University

    Omaha, Nebraska 68131
    United States

    Site Not Available

  • University of Rochester Medical Center - PPDS

    Rochester, New York 14642
    United States

    Site Not Available

  • PulmonIx LLC

    Greensboro, North Carolina 27403
    United States

    Site Not Available

  • UC Health Department of Internal Medicine, Pulmonary, Critical Care & Sleep Medicine

    Cincinnati, Ohio 45267
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195-0001
    United States

    Site Not Available

  • The Oregon Clinic

    Portland, Oregon 97220
    United States

    Site Not Available

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Rhode Island Hospital

    Providence, Rhode Island 02903
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • University of Texas Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Site Not Available

  • Houston Methodist Hospital

    Houston, Texas 77030
    United States

    Site Not Available

  • Metroplex Pulmonary and Sleep Medicine Center

    McKinney, Texas 75069
    United States

    Site Not Available

  • University of Texas Health Science Center San Antonio

    San Antonio, Texas 78229
    United States

    Site Not Available

  • University of Utah Medical Care

    Salt Lake City, Utah 84108
    United States

    Site Not Available

  • University of Virginia

    Charlottesville, Virginia 22908
    United States

    Site Not Available

  • Western Washington Medical Group

    Everett, Washington 98208
    United States

    Site Not Available

  • University of Washington Medical Center

    Seattle, Washington 98195
    United States

    Site Not Available

  • University of Wisconsin

    Madison, Wisconsin 53792
    United States

    Site Not Available

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