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Idiopathic Pulmonary FibrosisPhase 3ISABELA1NCT03711162

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

A Phase 3 study testing GLPG1690 in people with Idiopathic Pulmonary Fibrosis, run by Lakefront Biotherapeutics NV at 132 sites in 15 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Idiopathic Pulmonary Fibrosis
What is being tested?
GLPG1690
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
525 participants
Where
132 sitesin 15 countries
Study dates
28 Nov 2018to 30 Mar 2021
Phase
Phase 3
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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 applicable American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Association (ALAT) guidelines at the time of diagnosis.
  • Chest high-resolution computed tomography (HRCT) historically performed within 12 months prior to the screening visit and according to the minimum requirements for IPF diagnosis 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 criteria in either situation). If an evaluable HRCT <12 months prior to screening is not available, an HRCT can be performed at screening to determine eligibility, according to the same requirements as the historical HRCT.
  • Subjects receiving local standard of care for the treatment of IPF, defined as either pirfenidone 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 stable dose 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 most recent HRCT scan (investigator-determined).
  • Meeting all of the following criteria during the screening period: FVC ≥45% predicted of normal, Forced expiratory volume in 1 second (FEV1)/FVC ≥0.7, diffusing capacity of the lung for carbon monoxide (DLCO) corrected for Hb ≥30% predicted of normal.
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  • Estimated minimum life expectancy of at least 30 months for non IPF related disease in the opinion of the investigator.
  • Male subjects and female subjects of childbearing potential agree to use highly effective contraception/preventive exposure measures from the time of first dose of investigational medicinal product (IMP) (for the male subject) or the signing of the ICF (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 screening Visit 1; without having a contraindication to perform the 6MWT or without a condition putting 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 any condition. 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 6 L O2/minute or ≥88% with 0, 2 or 4 L O2/minute.

Who cannot join

  • History of malignancy within the past 5 years (except for carcinoma in situ of the uterine cervix, basal cell carcinoma of the skin that has been treated with no evidence of recurrence, prostate cancer that has been medically managed through active surveillance or watchful waiting, squamous cell carcinoma of the skin if fully resected, and Ductal Carcinoma In Situ).
  • Clinically significant abnormalities detected on ECG of either rhythm or conduction, a QT interval corrected for heart rate using Fridericia's formula (QTcF) >450 ms, or a known long QT syndrome. Patients with implantable cardiovascular devices (e.g. pacemaker) affecting the QT interval time may be enrolled in the study based upon investigator judgment following cardiologist consultation if deemed necessary, and only after discussion with the medical monitor.
  • Acute IPF exacerbation within 6 months prior to screening and/or during the screening period. The definition of an acute IPF exacerbation is as follows: Previous or concurrent diagnosis of IPF; Acute worsening or development of dyspnea typically < 1 month duration; Computed tomography with new bilateral ground-glass opacity and/or consolidation superimposed on a background pattern consistent with usual interstitial pneumonia pattern and deterioration not fully explained by cardiac failure or fluid overload.
  • Lower respiratory tract infection requiring treatment within 4 weeks prior to screening and/or during the screening period.
  • Interstitial lung disease associated with known primary diseases (e.g. sarcoidosis and amyloidosis), exposures (e.g. radiation, silica, asbestos, and coal dust), or drugs (e.g. amiodarone).
  • Diagnosis of severe pulmonary hypertension (investigator- determined).
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  • Unstable cardiovascular, pulmonary (other than IPF), or other disease within 6 months prior to screening or during the screening period (e.g. acute coronary disease, heart failure, and stroke).
  • Had gastric perforation within 3 months prior to screening or during screening, and/or underwent major surgery within 3 months prior to screening, during screening or have major surgery planned during the study period.
  • History of nintedanib-related increase in ALT and/or AST of >5 x upper limit of the normal range (ULN) and increased susceptibility to elevated LFT; moderate to severe hepatic impairment (Child-Pugh B or C) and/or abnormal liver function test (LFT) at screening, defined as aspartate aminotransferase (AST), and/or alanine aminotransferase (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 for abnormal LFT.
  • Abnormal renal function defined as estimated creatinine clearance, calculated according 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 the screening 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.

Trial locations and contacts

132 sites in 15 countries.

132 sites in 15 countries

United States47 sites
  • University of Colorado

    Aurora, Colorado, 80045

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

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

    Boston, Massachusetts, 02114

  • Caritas St. Elizabeth's Medical Center

    Boston, Massachusetts, 02135

  • PAB Clinical Research - ClinEdge - PPDS

    Brandon, Florida, 33511

  • University of Virginia

    Charlottesville, Virginia, 22908

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

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

    Cincinnati, Ohio, 45267

  • St. Francis Medical Institute - BTC - PPDS

    Clearwater, Florida, 33765

  • Cleveland Clinic

    Cleveland, Ohio, 44195-0001

  • Pulmonary and Infections Disease Associates

    Council Bluffs, Iowa, 51503

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Western Connecticut Medical Group

    Danbury, Connecticut, 06810

  • Henry Ford Health System

    Dearborn, Michigan, 48124

  • National Jewish Health

    Denver, Colorado, 80206

  • Western Washington Medical Group

    Everett, Washington, 98208

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

    Gainesville, Florida, 32608

  • University of Florida

    Gainesville, Florida, 32610

  • PulmonIx LLC

    Greensboro, North Carolina, 27403

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • Atria Clinical Research - BTC - PPDS

    Little Rock, Arkansas, 72209

  • David Geffen School of Medicine at UCLA

    Los Angeles, California, 90095

  • University of Louisville

    Louisville, Kentucky, 40202

  • Advanced Pulmonary Research Institute

    Loxahatchee Groves, Florida, 33470

  • University of Wisconsin

    Madison, Wisconsin, 53792

  • Metroplex Pulmonary and Sleep Medicine Center

    McKinney, Texas, 75069

  • Minnesota Lung Center

    Minneapolis, Minnesota, 55407

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Yale University School of Medicine

    New Haven, Connecticut, 06510

  • Tulane Medical Center

    New Orleans, Louisiana, 70112

  • Creighton University

    Omaha, Nebraska, 68131

  • Respire Research

    Palm Springs, California, 92262

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Pulmonary Associates

    Phoenix, Arizona, 85006

  • The Oregon Clinic

    Portland, Oregon, 97220

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Mayo Clinic - PPDS

    Rochester, Minnesota, 55905

  • University of Rochester Medical Center - PPDS

    Rochester, New York, 14642

  • University of Utah Medical Care

    Salt Lake City, Utah, 84108

  • University of Texas Health Science Center San Antonio

    San Antonio, Texas, 78229

  • University of California San Diego

    San Diego, California, 92037

  • Mayo Clinic Arizona - PPDS

    Scottsdale, Arizona, 85259

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Stanford University Medical Center

    Stanford, California, 94305

  • MedStar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

Other trials in United States

United Kingdom11 sites
  • Birmingham Heartlands Hospital

    Birmingham, B9 5SS

  • Southmead Hospital

    Bristol, BS10 5NB

  • Papworth Hospital

    Cambridge, CB233RE

  • Castle Hill Hospital

    Cottingham, HU16 5JQ

  • Royal Devon and Exeter Hospital NHS Trust

    Exeter, EX2 5DW

  • Aintree University Hospital NHS Foundation Trust

    Liverpool, L9 7AL

  • Royal Brompton Hospital

    London, SW3 6NP

  • Wythenshawe Hospital - PPDS

    Manchester, M23 9LT

  • The Newcastle Upon Tyne Hospitals NHS Foundation Trust

    Newcastle, NE14LP

  • Nottingham City Hospital

    Nottingham, NG5 1PB

  • Northern General Hospital

    Sheffield, S5 7AU

Other trials in United Kingdom

Australia10 sites
  • Royal Adelaide Hospital

    Adelaide, 5000

  • Flinders Medical Centre

    Bedford Park, 5042

  • Box Hill Hospital

    Box Hill, VIC 3128

  • Corte Royal Prince Alfred Hospital

    Camperdown, NSW 2050

  • Lung Research Queensland

    Chermside, QLD 4060

  • Concord Repatriation General Hospital

    Concord, NSW 2139

  • St Vincent's Hospital Sydney

    Darlinghurst, NSW 2010

  • Austin Health

    Heidelberg, 3084

  • Respiratory Clinical Trials Pty Ltd

    Kent Town, SA 5067

  • The Alfred Hospital

    Melbourne, VIC 3004

Other trials in Australia

Chile9 sites
  • Hospital Clínico Regional de Concepción Dr Guillermo Grant Benavente

    Concepción, 4070038

  • Centro de Investigación Curico

    Curicó, 3341643

  • Centro Respiratorio Integral LTDA. (CENRESIN)

    Quillota, 2260000

  • Instituto Nacional Torax

    Santiago, 7500691

  • Centro de Investigaciones Medicas Respiratorias CIMER

    Santiago, 7500692

  • Hospital Dr Sotero Del Rio

    Santiago, 8207257

  • Centro de Investigacion del Maule

    Talca, 3465584

  • Hospital Carlos Van Buren

    Valparaíso, 2352499

  • CINVEC- Estudos Clínicos Quinta Región Limitada

    Viña del Mar, 2520024

Other trials in Chile

Spain8 sites
  • Hospital Clinical de Barcelona

    Barcelona, 03036

  • Hospital Universitario de Bellvitge, Hospitalet De Llobregat

    Barcelona, 08097

  • Hospital Universitario de La Princesa

    Madrid, 28006

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Clinica Universidad Navarra

    Pamplona, 31008

  • Hospital Universitario Marques de Valdecilla

    Santander, 39008

  • Consorcio Hospital General Universitario de Valencia

    Valencia, 46014

  • CHUVI - H.U. Alvaro Cunquerio

    Vigo, Pontevedra, 36312

Other trials in Spain

Germany7 sites
  • Zentralklinik Bad Berka GmbH

    Bad Berka, 99437

  • Evangelische Lungenklinik

    Berlin, 13125

  • Fachkrankenhaus Coswig

    Coswig, 01640

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Thorax Klinik

    Heidelberg, 69126

  • Universitatsklinikum Leipzig

    Leipzig, 04103

  • Klinikum Rosenheim

    Rosenheim, 83022

Other trials in Germany

Japan7 sites
  • Tenryu Hospital

    Hamamatsu, 434-8511

  • Saiseikai Kumamoto Hospital

    Kumamoto, 861-4193

  • National Hospital Organization Kinki-Chuo Chest Medical Center

    Sakai, 591-8555

  • Tosei General Hospital

    Seto, 489-0065

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

    Tokyo, 162-0052

  • National Hospital Organization Kyushu Medical Center

    Tokyo, 810-8563

  • Kanagawa Cardiovascular and Respiratory Center

    Yokohama, 236-0051

Other trials in Japan

Peru6 sites
  • Hospital Chancay y Servicios Basicos de Salud

    Chancay, 15131

  • Hospital Nacional Guillermo Almenara Irigoyen ESSALUD

    Lima

  • Clinica Internacional - PPDS

    Lima Cercado

  • Clinica Ricardo Palma - PPDS

    San Isidro

  • Clinica Providencia (Inverconsult Sociedad Anonima)

    San Miguel

  • Clinica San Pablo

    Santiago de Surco

Other trials in Peru

Belgium5 sites
  • ZNA Middelheim

    Antwerp, 2020

  • Hôpital Erasme

    Brussels, 1070

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • UZ Leuven

    Leuven, 3000

  • CHU UCL Namur asbl - Site Godinne

    Yvoir, 5530

Other trials in Belgium

Greece5 sites
  • Sotiria Chest Hospital of Athens

    Athens, 11527

  • Attikon University General Hospital

    Athens, 12464

  • University General Hospital of Heraklion

    Heraklion, 71110

  • University General Hospital of Larissa

    Larissa, 41110

  • Georgios Papanikolaou General Hospital of Thessaloniki

    Thessaloniki, 57010

Other trials in Greece

Czechia4 sites
  • Fakultni nemocnice Brno

    Brno, 62500

  • Fakultni nemocnice Ostrava

    Ostrava, 708 52

  • Thomayerova nemocnice

    Prague, 14059

  • Nemocnice Na Bulovce

    Prague, 180 81

Other trials in Czechia

Taiwan4 sites
  • Kaohsiung Medical University Hospital

    Kaohsiung City, 807

  • Far Eastern Memorial Hospital

    New Taipei City, 220

  • Taipei Medical University Shuang Ho Hospital

    New Taipei City, 23561

  • National Taiwan University Hospital

    Taipei, 10002

Other trials in Taiwan

Turkey (Türkiye)4 sites
  • Süreyyapaşa Göğüs Hastalıkları Ve Göğüs Cerrahisi Eğitim Ve Araştırma Hastanesi

    Istanbul, 34854

  • Ege Universitesi Tıp Fakultesi Hastanesi Gögus Hastalıkları Anabilim Dalı

    Izmir, 35100

  • Uludag Universitesi Tıp Fakultesi Hastanesi Gögüs Hastalıkları Anabilim Dalı

    Izmir, 35100

  • Mersin Üniversitesi Tıp Fakültesi Hastanesi Göğüs Hastalıkları Polikinliği

    Mersin, 33169

Other trials in Turkey (Türkiye)

Denmark3 sites
  • Aarhus Universitetshospital

    Aarhus, 8200

  • Gentofte Hospital

    Hellerup, 2900

  • Odense Universitetshospital

    Odense, 5000

Other trials in Denmark

Brazil2 sites
  • Irmandade Da Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, 90035-074

  • Faculdade de Medicina Do ABC

    Santo André, 09060-870

Other trials in Brazil

About this study

Official title: A Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled Multicenter Study to Evaluate the Efficacy and Safety of Two Doses of GLPG1690 in Addition to Local Standard of Care for Minimum 52 Weeks in Subjects With Idiopathic Pulmonary Fibrosis

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).

Being tested
GLPG1690, Placebo
Medical subject headings
Idiopathic Pulmonary Fibrosis

What participants receive

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

  • GLPG1690Drug

    Also called ziritaxestat

    GLPG1690, film-coated tablets for oral use.

  • PlaceboDrug

    Matching placebo, film-coated tablets for oral use.

Study groups in NCT03711162
Study groupRoleWhat they receive
GLPG1690 600 mgExperimentalParticipants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).
Receives: Drug: GLPG1690
GLPG1690 200 mgExperimentalParticipants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet for oral use once daily (mean GLPG1690 exposure was up to 356.0 days) in addition to local standard of care. Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).
Receives: Drug: GLPG1690
PlaceboPlacebo comparatorParticipants received GLPG1690 (ziritaxestat) matching placebo tablets for oral use once daily (mean GLPG1690 exposure was up to 353.4 days) in addition to local standard of care. Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).
Receives: Drug: Placebo

What is being measured

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

  1. Annual Rate of Decline in FVC up to Week 52

    FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.

    Measured: Baseline up to week 52

Secondary outcomes (34)
  1. Percentage of Participants With Disease Progression up to Week 52

    Disease progression was defined as the composite occurrence of more than or equal to (>=)10 percent (%) absolute decline in percent predicted forced vital capacity (%FVC) or all-cause mortality. FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.

    Measured: Up to week 52

  2. Percentage of Participants With Respiratory-Related Hospitalization Until End of Study (EoS)

    Percentage of participants with respiratory related hospitalization were reported in this measure.

    Measured: Up to EoS (week 121)

  3. Change From Baseline in St.George's Respiratory Questionnaire (SGRQ) Total Score at Week 52

    SGRQ is a 50-item paper questionnaire designed to measure and quantify the impact of chronic respiratory disease on health-related quality of life (QOL) and well-being, split into 3 domains: symptoms score assessing the frequency and severity of respiratory symptoms (Items 1-8), activity score assessing the effects of breathlessness on mobility and physical activity (Items 11-17 and 36 to 44), and impacts score assessing the psychosocial impact of the disease (Items 9-10, 18-35 and 45-50). Each item has a specific weight.

    Domain scores = 100 * summed weights from positive items in that component/sum of maximum weights for all non-missing items in that component

    Total score = 100 * summed weights from positive items in the questionnaire/sum of maximum weights for all non-missing items in the questionnaire

    Scores were weighted such that each domain score ranged from 0 to 100 and the total score ranged from 0 to 100, with higher scores indicating the poorer health-related QOL.

    Measured: Baseline, week 52

  4. Annual Rate of Decline in FVC Until EoS

    FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.

    Measured: Baseline up to EoS (week 121)

  5. Percentage of Participants With Disease Progression Until EoS

    Disease progression was defined as the composite occurrence of >=10% absolute decline in percent predicted %FVC or all-cause mortality. FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.

    Measured: Up to EoS (week 121)

  6. Change From Baseline in St.George's Respiratory Questionnaire (SGRQ) Total Score at Week 100

    SGRQ is a 50-item paper questionnaire designed to measure and quantify the impact of chronic respiratory disease on health-related quality of life (QOL) and well-being, split into 3 domains: symptoms score assessing the frequency and severity of respiratory symptoms (Items 1-8), activity score assessing the effects of breathlessness on mobility and physical activity (Items 11-17 and 36 to 44), and impacts score assessing the psychosocial impact of the disease (Items 9-10, 18-35 and 45-50). Each item has a specific weight.

    Domain scores = 100 * summed weights from positive items in that component/sum of maximum weights for all non-missing items in that component Total score = 100 * summed weights from positive items in the questionnaire/sum of maximum weights for all non-missing items in the questionnaire Scores were weighted such that each domain score ranged from 0 to 100 and the total score ranged from 0 to 100, with higher scores indicating the poorer health-related QOL.

    Measured: Baseline, week 100

  7. Percentage of Participants With All Cause Hospitalization Until EoS

    Percentage of participants with all cause hospitalization was reported for this measure.

    Measured: Up to EoS (week 121)

  8. Percentage of Participants With Respiratory Related Mortality Until EoS

    Percentage of participants with respiratory related mortality until EoS were reported for this study.

    Measured: Up to EoS (week 121)

  9. Percentage of Participants Hospitalized for Non-elective Lung Transplant Until EoS

    Percentage of Participants who were hospitalized for Non-elective lung transplant were reported for this measure.

    Measured: Up to EoS (week 121)

  10. Percentage of Participants With Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation Until EoS

    Percentage of participants with acute IPF exacerbation until EoS were reported for this measure.

    Measured: Up to EoS (week 121)

  11. Percentage of Participants With All Cause Mortality or Hospitalization for Non-elective Lung Transplant Until EoS

    Percentage of participants with all-cause mortality or hospitalization for non-elective lung transplant were reported for this measure.

    Measured: Up to EoS (week 121)

  12. Percentage of Participants With All Cause Mortality, Hospitalization for Non-elective Lung Transplant or Hospitalization for Qualifying for Lung Transplant Until EoS

    Percentage of participants with all-cause mortality or hospitalization for non-elective lung transplant or hospitalization for qualifying for lung transplant were reported for this measure.

    Measured: Up to EoS (week 121)

  13. Percentage of Participants With All-Cause Mortality or Hospitalization That Meets >=10% Absolute Decline in %FVC or Respiratory-Related Hospitalization Until EoS

    Percentage of participants with all-cause mortality or respiratory related hospitalization that meets >=10% absolute decline in %FVC or respiratory-related hospitalization were reported for this measure.

    Measured: Up to EoS (week 121)

  14. Percentage of Participants With All-Cause Mortality or Respiratory-Related Hospitalizations Until EoS

    Percentage of participants with all-cause mortality or respiratory related hospitalization were reported for this measure.

    Measured: Up to EoS (week 121)

  15. FVC at Week 52

    FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.

    Measured: Week 52

  16. Change From Baseline in FVC at Week 52

    FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.

    Measured: Baseline, week 52

  17. Percent Change From Baseline in FVC at Week 52

    FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.

    Measured: Baseline, week 52

  18. FVC at Week 112

    FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.

    Measured: Week 112

  19. Change From Baseline in FVC at Week 112

    FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.

    Measured: Baseline, week 112

  20. Percent Change From Baseline in FVC at Week 112

    FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.

    Measured: Baseline, week 112

  21. Percentage of Participants With Absolute Categorical Change From Baseline in Percent FVC at Week 52: FVC Change Within ≤5

    FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.

    Measured: Baseline, week 52

  22. Percentage of Participants With Absolute Categorical Change From Baseline in Percent FVC at Week 112: FVC Change Within ≤5

    FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.

    Measured: Baseline, week 112

  23. Percentage of Participants With Absolute Categorical Change From Baseline in Percent FVC at Week 52: FVC Change Within ≤10

    FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.

    Measured: Baseline, week 52

  24. Percentage of Participants With Absolute Categorical Change From Baseline in Percent FVC at Week 112: FVC Change Within ≤10

    FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.

    Measured: Baseline, week 112

  25. Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs

    Safety was assessed by AEs, which included abnormalities identified during a medical test (example, laboratory tests, vital signs, electrocardiogram, etc.) if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study drug or was clinically significant. A Treatment emergent AE (TEAE) was defined as any AE that started or worsened after the first dose of study drug up to 30 days after the last dose of study drug. AEs were considered serious (SAEs) if the AE resulted in death, was life-threatening, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, resulted in congenital anomaly, or birth defect or required inpatient hospitalization or led to prolongation of hospitalization.

    Measured: Baseline up to 30 days after the last dose (up to week 121)

  26. Changes From Baseline Leicester Cough Questionnaire (LCQ) Total Score and Individual Domain Score at Week 52 and Week 100

    Cough was evaluated using the LCQ. The LCQ was a 19-item questionnaire split into three domains: physical, psychological, and social. Scores were calculated by domain (range from 1 to 7, higher scores indicated a better health status) and then the total score was calculated by adding the individual domain score. Total score ranged from 3 to 21, with higher scores indicated a better health status.

    Measured: Baseline, week 52, week 100

  27. Change From Baseline in Visual Analogue Score (VAS): Cough at Week 52 and Week 100

    Cough was assessed using VAS score, ranged from 0 (no cough) to 100 millimeter (mm) (worst possible cough).

    Measured: Baseline, week 52, week 100

  28. Change From Baseline in Visual Analogue Score (VAS): Urge to Cough at Week 52 and Week 100

    Urge to Cough was assessed using VAS score, ranged from 0 (no urge to cough) to 100 mm (highest urge to cough).

    Measured: Baseline, week 52, week 100

  29. Change From Baseline in European Quality Of Life (EQ) VAS at Week 52 and Week 100

    EuroQol outcome measurements is a printed 20 cm VAS that appears somewhat like a thermometer, on which a score from 0 (worst imaginable health state or death) to 100 (best imaginable health state) was marked by the participant (or, when necessary, their proxy) with the scale in view.

    Measured: Baseline, week 52, week 100

  30. Change From Baseline in King's Brief Interstitial Lung Disease (K-BILD) at Week 52 and Week 100

    The K-BILD questionnaire was specifically developed to analyze the health status of participants with ILD. The questionnaire consists of 15 items (assessed by the participants on a scale ranging from 1 to 7, where 1 and 7 represent worst and best health status). Items are compiled into 3 domains: breathlessness and activities (range: 0-21), psychological (range: 0-34) , and chest symptoms (range: 0-8). To score the K-BILD, the Likert response scale weightings for individual items are combined and scores are transformed to a range of 0-100 by using logit values (higher scores indicate better health status).

    Measured: Baseline, week 52, week 100

  31. Area Under The Concentration Time Curve (AUC) of Ziritaxtestat

    Area under the concentration time curve of ziritaxtestat was reported.

    Measured: Sparse samples collected on day 1 pre-dose, day 85 post-dose, day 237 post-dose, day 183 pre-dose, day 365 pre-dose

  32. Maximum Observed Plasma Concentration (Cmax) of Ziritaxtestat

    Maximum Observed Plasma Concentration of Ziritaxtestat was reported.

    Measured: Sparse samples collected on day 1 pre-dose, day 85 post-dose, day 237 post-dose, day 183 pre-dose, day 365 pre-dose

  33. Change From Baseline in Total Distance Walked in Six-minute Walk Test (6MWT) at Week 52 and Week 100

    The 6-MWT depicted the total distance covered by a participant during 6 minutes of walking.

    Measured: Baseline, week 52, week 100

  34. Change From Baseline in Diffusing Capacity of Lung for Carbon Monoxide (DLCO) (Corrected for Hemoglobin [Hb]) at Week 52 and Week 100

    Change from baseline in DLCO (percent predicted hemoglobin level corrected) was reported for this measure.mmol/min/kPa: Millimole per minute per kilopascal

    Measured: Baseline, week 52, week 100

Timeline

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

  1. First posted18 Oct 2018
  2. Study start28 Nov 2018
  3. Primary completion30 Mar 2021
  4. Study completion30 Mar 2021

Why it stopped: The benefit-risk profile no longer supports continuing the study

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
525 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03711162
Sponsor's protocol ID
GLPG1690-CL-303
Other IDs
2018-001405-87, 2018
Acronym
ISABELA1
Status last verified
Jul 2022
First submitted
15 Oct 2018
Last updated
29 Jul 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ford P, Kreuter M, Brown KK, Wuyts WA, Wijsenbeek M, Israel-Biet D, Hubbard R, Nathan SD, Nunes H, Penninckx B, Prasad N, Seghers I, Spagnolo P, Verbruggen N, Hirani N, Behr J, Kaner RJ, Maher TM. An adjudication algorithm for respiratory-related hospitalisation in idiopathic pulmonary fibrosis. ERJ Open Res. 2024 Jan 29;10(1):00636-2023. doi: 10.1183/23120541.00636-2023. eCollection 2024 Jan.

    PubMed 38288082
  • Maher TM, Ford P, Brown KK, Costabel U, Cottin V, Danoff SK, Groenveld I, Helmer E, Jenkins RG, Milner J, Molenberghs G, Penninckx B, Randall MJ, Van Den Blink B, Fieuw A, Vandenrijn C, Rocak S, Seghers I, Shao L, Taneja A, Jentsch G, Watkins TR, Wuyts WA, Kreuter M, Verbruggen N, Prasad N, Wijsenbeek MS; ISABELA 1 and 2 Investigators. Ziritaxestat, a Novel Autotaxin Inhibitor, and Lung Function in Idiopathic Pulmonary Fibrosis: The ISABELA 1 and 2 Randomized Clinical Trials. JAMA. 2023 May 9;329(18):1567-1578. doi: 10.1001/jama.2023.5355.

    PubMed 37159034
  • Maher TM, Kreuter M, Lederer DJ, Brown KK, Wuyts W, Verbruggen N, Stutvoet S, Fieuw A, Ford P, Abi-Saab W, Wijsenbeek M. Rationale, design and objectives of two phase III, randomised, placebo-controlled studies of GLPG1690, a novel autotaxin inhibitor, in idiopathic pulmonary fibrosis (ISABELA 1 and 2). BMJ Open Respir Res. 2019 May 21;6(1):e000422. doi: 10.1136/bmjresp-2019-000422. eCollection 2019.

    PubMed 31179008

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GLPG1690 in people with Idiopathic Pulmonary Fibrosis, run by Lakefront Biotherapeutics NV at 132 sites in 15 countries.

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 9 inclusion and 11 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: stopped early, as of the sponsor's last update on 29 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 132 sites in United States, United Kingdom, Australia, Chile, Spain and 10 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 29 Jul 2022). 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?

Annual Rate of Decline in FVC up to Week 52 (time frame: Baseline up to week 52). 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 NCT03711162, which also lists 3 linked publications.

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 29 Jul 2022; AzTrials last refreshed its copy on 27 Oct 2026.

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