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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 (ISABELA1)

Primary Purpose

Idiopathic Pulmonary Fibrosis

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
GLPG1690
Placebo
Sponsored by
Galapagos NV
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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.
  • 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.

Exclusion Criteria:

  • 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).
  • 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.

Sites / Locations

  • Pulmonary Associates
  • Mayo Clinic Arizona - PPDS
  • Atria Clinical Research - BTC - PPDS
  • David Geffen School of Medicine at UCLA
  • Respire Research
  • University of California San Diego
  • Stanford University Medical Center
  • University of Colorado
  • National Jewish Health
  • Western Connecticut Medical Group
  • Yale University School of Medicine
  • MedStar Georgetown University Hospital
  • PAB Clinical Research - ClinEdge - PPDS
  • St. Francis Medical Institute - BTC - PPDS
  • North Florida/South Georgia Veterans Health System-NAVREF-PPDS
  • University of Florida
  • Advanced Pulmonary Research Institute
  • Northwestern Memorial Hospital
  • Pulmonary and Infections Disease Associates
  • University of Louisville
  • Tulane Medical Center
  • University of Maryland Medical Center
  • Massachusetts General Hospital, Division of Pulmonary and Critical Care Medicine
  • Caritas St. Elizabeth's Medical Center
  • Henry Ford Health System
  • Minnesota Lung Center
  • Mayo Clinic - PPDS
  • Washington University School of Medicine
  • Creighton University
  • University of Rochester Medical Center - PPDS
  • PulmonIx LLC
  • UC Health Department of Internal Medicine, Pulmonary, Critical Care & Sleep Medicine
  • Cleveland Clinic
  • The Oregon Clinic
  • Penn State Milton S Hershey Medical Center
  • Hospital of the University of Pennsylvania
  • Rhode Island Hospital
  • Vanderbilt University Medical Center
  • University of Texas Southwestern Medical Center
  • Houston Methodist Hospital
  • Metroplex Pulmonary and Sleep Medicine Center
  • University of Texas Health Science Center San Antonio
  • University of Utah Medical Care
  • University of Virginia
  • Western Washington Medical Group
  • University of Washington Medical Center
  • University of Wisconsin
  • Royal Adelaide Hospital
  • Flinders Medical Centre
  • Box Hill Hospital
  • Corte Royal Prince Alfred Hospital
  • Lung Research Queensland
  • Concord Repatriation General Hospital
  • St Vincent's Hospital Sydney
  • Austin Health
  • Respiratory Clinical Trials Pty Ltd
  • The Alfred Hospital
  • ZNA Middelheim
  • Hôpital Erasme
  • Cliniques Universitaires Saint-Luc
  • UZ Leuven
  • CHU UCL Namur asbl - Site Godinne
  • Irmandade Da Santa Casa de Misericordia de Porto Alegre
  • Faculdade de Medicina Do ABC
  • Hospital Clínico Regional de Concepción Dr Guillermo Grant Benavente
  • Centro de Investigación Curico
  • Centro Respiratorio Integral LTDA. (CENRESIN)
  • Instituto Nacional Torax
  • Centro de Investigaciones Medicas Respiratorias CIMER
  • Hospital Dr Sotero Del Rio
  • Centro de Investigacion del Maule
  • Hospital Carlos Van Buren
  • CINVEC- Estudos Clínicos Quinta Región Limitada
  • Fakultni nemocnice Brno
  • Fakultni nemocnice Ostrava
  • Thomayerova nemocnice
  • Nemocnice Na Bulovce
  • Aarhus Universitetshospital
  • Gentofte Hospital
  • Odense Universitetshospital
  • Zentralklinik Bad Berka GmbH
  • Evangelische Lungenklinik
  • Fachkrankenhaus Coswig
  • Medizinische Hochschule Hannover
  • Thorax Klinik
  • Universitatsklinikum Leipzig
  • Klinikum Rosenheim
  • Sotiria Chest Hospital of Athens
  • Attikon University General Hospital
  • University General Hospital of Heraklion
  • University General Hospital of Larissa
  • Georgios Papanikolaou General Hospital of Thessaloniki
  • Tenryu Hospital
  • Saiseikai Kumamoto Hospital
  • National Hospital Organization Kinki-Chuo Chest Medical Center
  • Tosei General Hospital
  • Center Hospital of the National Center for Global Health and Medicine
  • National Hospital Organization Kyushu Medical Center
  • Kanagawa Cardiovascular and Respiratory Center
  • Hospital Chancay y Servicios Basicos de Salud
  • Clinica Internacional - PPDS
  • Hospital Nacional Guillermo Almenara Irigoyen ESSALUD
  • Clinica Ricardo Palma - PPDS
  • Clinica Providencia (Inverconsult Sociedad Anonima)
  • Clinica San Pablo
  • CHUVI - H.U. Alvaro Cunquerio
  • Hospital Clinical de Barcelona
  • Hospital Universitario de Bellvitge, Hospitalet De Llobregat
  • Hospital Universitario de La Princesa
  • Hospital Clinico San Carlos
  • Clinica Universidad Navarra
  • Hospital Universitario Marques de Valdecilla
  • Consorcio Hospital General Universitario de Valencia
  • Kaohsiung Medical University Hospital
  • Far Eastern Memorial Hospital
  • Taipei Medical University Shuang Ho Hospital
  • National Taiwan University Hospital
  • Süreyyapaşa Göğüs Hastalıkları Ve Göğüs Cerrahisi Eğitim Ve Araştırma Hastanesi
  • Ege Universitesi Tıp Fakultesi Hastanesi Gögus Hastalıkları Anabilim Dalı
  • Uludag Universitesi Tıp Fakultesi Hastanesi Gögüs Hastalıkları Anabilim Dalı
  • Mersin Üniversitesi Tıp Fakültesi Hastanesi Göğüs Hastalıkları Polikinliği
  • Birmingham Heartlands Hospital
  • Southmead Hospital
  • Papworth Hospital
  • Castle Hill Hospital
  • Royal Devon and Exeter Hospital NHS Trust
  • Aintree University Hospital NHS Foundation Trust
  • Royal Brompton Hospital
  • Wythenshawe Hospital - PPDS
  • The Newcastle Upon Tyne Hospitals NHS Foundation Trust
  • Nottingham City Hospital
  • Northern General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

GLPG1690 600 mg

GLPG1690 200 mg

Placebo

Arm Description

Participants 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).

Participants 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).

Participants 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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Percentage of Participants With Respiratory-Related Hospitalization Until End of Study (EoS)
Percentage of participants with respiratory related hospitalization were reported in this measure.
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.
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.
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.
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.
Percentage of Participants With All Cause Hospitalization Until EoS
Percentage of participants with all cause hospitalization was reported for this measure.
Percentage of Participants With Respiratory Related Mortality Until EoS
Percentage of participants with respiratory related mortality until EoS were reported for this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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).
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.
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).
Area Under The Concentration Time Curve (AUC) of Ziritaxtestat
Area under the concentration time curve of ziritaxtestat was reported.
Maximum Observed Plasma Concentration (Cmax) of Ziritaxtestat
Maximum Observed Plasma Concentration of Ziritaxtestat was reported.
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.
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

Full Information

First Posted
October 15, 2018
Last Updated
July 6, 2022
Sponsor
Galapagos NV
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1. Study Identification

Unique Protocol Identification Number
NCT03711162
Brief Title
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
Acronym
ISABELA1
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Terminated
Why Stopped
The benefit-risk profile no longer supports continuing the study
Study Start Date
November 28, 2018 (Actual)
Primary Completion Date
March 30, 2021 (Actual)
Study Completion Date
March 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galapagos NV

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
525 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GLPG1690 600 mg
Arm Type
Experimental
Arm Description
Participants 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).
Arm Title
GLPG1690 200 mg
Arm Type
Experimental
Arm Description
Participants 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).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants 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).
Intervention Type
Drug
Intervention Name(s)
GLPG1690
Other Intervention Name(s)
ziritaxestat
Intervention Description
GLPG1690, film-coated tablets for oral use.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo, film-coated tablets for oral use.
Primary Outcome Measure Information:
Title
Annual Rate of Decline in FVC up to Week 52
Description
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.
Time Frame
Baseline up to week 52
Secondary Outcome Measure Information:
Title
Percentage of Participants With Disease Progression up to Week 52
Description
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.
Time Frame
Up to week 52
Title
Percentage of Participants With Respiratory-Related Hospitalization Until End of Study (EoS)
Description
Percentage of participants with respiratory related hospitalization were reported in this measure.
Time Frame
Up to EoS (week 121)
Title
Change From Baseline in St.George's Respiratory Questionnaire (SGRQ) Total Score at Week 52
Description
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.
Time Frame
Baseline, week 52
Title
Annual Rate of Decline in FVC Until EoS
Description
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.
Time Frame
Baseline up to EoS (week 121)
Title
Percentage of Participants With Disease Progression Until EoS
Description
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.
Time Frame
Up to EoS (week 121)
Title
Change From Baseline in St.George's Respiratory Questionnaire (SGRQ) Total Score at Week 100
Description
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.
Time Frame
Baseline, week 100
Title
Percentage of Participants With All Cause Hospitalization Until EoS
Description
Percentage of participants with all cause hospitalization was reported for this measure.
Time Frame
Up to EoS (week 121)
Title
Percentage of Participants With Respiratory Related Mortality Until EoS
Description
Percentage of participants with respiratory related mortality until EoS were reported for this study.
Time Frame
Up to EoS (week 121)
Title
Percentage of Participants Hospitalized for Non-elective Lung Transplant Until EoS
Description
Percentage of Participants who were hospitalized for Non-elective lung transplant were reported for this measure.
Time Frame
Up to EoS (week 121)
Title
Percentage of Participants With Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation Until EoS
Description
Percentage of participants with acute IPF exacerbation until EoS were reported for this measure.
Time Frame
Up to EoS (week 121)
Title
Percentage of Participants With All Cause Mortality or Hospitalization for Non-elective Lung Transplant Until EoS
Description
Percentage of participants with all-cause mortality or hospitalization for non-elective lung transplant were reported for this measure.
Time Frame
Up to EoS (week 121)
Title
Percentage of Participants With All Cause Mortality, Hospitalization for Non-elective Lung Transplant or Hospitalization for Qualifying for Lung Transplant Until EoS
Description
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.
Time Frame
Up to EoS (week 121)
Title
Percentage of Participants With All-Cause Mortality or Hospitalization That Meets >=10% Absolute Decline in %FVC or Respiratory-Related Hospitalization Until EoS
Description
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.
Time Frame
Up to EoS (week 121)
Title
Percentage of Participants With All-Cause Mortality or Respiratory-Related Hospitalizations Until EoS
Description
Percentage of participants with all-cause mortality or respiratory related hospitalization were reported for this measure.
Time Frame
Up to EoS (week 121)
Title
FVC at Week 52
Description
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.
Time Frame
Week 52
Title
Change From Baseline in FVC at Week 52
Description
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.
Time Frame
Baseline, week 52
Title
Percent Change From Baseline in FVC at Week 52
Description
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.
Time Frame
Baseline, week 52
Title
FVC at Week 112
Description
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.
Time Frame
Week 112
Title
Change From Baseline in FVC at Week 112
Description
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.
Time Frame
Baseline, week 112
Title
Percent Change From Baseline in FVC at Week 112
Description
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.
Time Frame
Baseline, week 112
Title
Percentage of Participants With Absolute Categorical Change From Baseline in Percent FVC at Week 52: FVC Change Within ≤5
Description
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.
Time Frame
Baseline, week 52
Title
Percentage of Participants With Absolute Categorical Change From Baseline in Percent FVC at Week 112: FVC Change Within ≤5
Description
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.
Time Frame
Baseline, week 112
Title
Percentage of Participants With Absolute Categorical Change From Baseline in Percent FVC at Week 52: FVC Change Within ≤10
Description
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.
Time Frame
Baseline, week 52
Title
Percentage of Participants With Absolute Categorical Change From Baseline in Percent FVC at Week 112: FVC Change Within ≤10
Description
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.
Time Frame
Baseline, week 112
Title
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
Description
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.
Time Frame
Baseline up to 30 days after the last dose (up to week 121)
Title
Changes From Baseline Leicester Cough Questionnaire (LCQ) Total Score and Individual Domain Score at Week 52 and Week 100
Description
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.
Time Frame
Baseline, week 52, week 100
Title
Change From Baseline in Visual Analogue Score (VAS): Cough at Week 52 and Week 100
Description
Cough was assessed using VAS score, ranged from 0 (no cough) to 100 millimeter (mm) (worst possible cough).
Time Frame
Baseline, week 52, week 100
Title
Change From Baseline in Visual Analogue Score (VAS): Urge to Cough at Week 52 and Week 100
Description
Urge to Cough was assessed using VAS score, ranged from 0 (no urge to cough) to 100 mm (highest urge to cough).
Time Frame
Baseline, week 52, week 100
Title
Change From Baseline in European Quality Of Life (EQ) VAS at Week 52 and Week 100
Description
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.
Time Frame
Baseline, week 52, week 100
Title
Change From Baseline in King's Brief Interstitial Lung Disease (K-BILD) at Week 52 and Week 100
Description
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).
Time Frame
Baseline, week 52, week 100
Title
Area Under The Concentration Time Curve (AUC) of Ziritaxtestat
Description
Area under the concentration time curve of ziritaxtestat was reported.
Time Frame
Sparse samples collected on day 1 pre-dose, day 85 post-dose, day 237 post-dose, day 183 pre-dose, day 365 pre-dose
Title
Maximum Observed Plasma Concentration (Cmax) of Ziritaxtestat
Description
Maximum Observed Plasma Concentration of Ziritaxtestat was reported.
Time Frame
Sparse samples collected on day 1 pre-dose, day 85 post-dose, day 237 post-dose, day 183 pre-dose, day 365 pre-dose
Title
Change From Baseline in Total Distance Walked in Six-minute Walk Test (6MWT) at Week 52 and Week 100
Description
The 6-MWT depicted the total distance covered by a participant during 6 minutes of walking.
Time Frame
Baseline, week 52, week 100
Title
Change From Baseline in Diffusing Capacity of Lung for Carbon Monoxide (DLCO) (Corrected for Hemoglobin [Hb]) at Week 52 and Week 100
Description
Change from baseline in DLCO (percent predicted hemoglobin level corrected) was reported for this measure.mmol/min/kPa: Millimole per minute per kilopascal
Time Frame
Baseline, week 52, week 100

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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. 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. Exclusion Criteria: 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). 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Galapagos Study Director, MD
Organizational Affiliation
Galapagos NV
Official's Role
Study Director
Facility Information:
Facility Name
Pulmonary Associates
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Mayo Clinic Arizona - PPDS
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Atria Clinical Research - BTC - PPDS
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72209
Country
United States
Facility Name
David Geffen School of Medicine at UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Respire Research
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
University of California San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
National Jewish Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
Western Connecticut Medical Group
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
MedStar Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
PAB Clinical Research - ClinEdge - PPDS
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
St. Francis Medical Institute - BTC - PPDS
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
North Florida/South Georgia Veterans Health System-NAVREF-PPDS
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Advanced Pulmonary Research Institute
City
Loxahatchee Groves
State/Province
Florida
ZIP/Postal Code
33470
Country
United States
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Pulmonary and Infections Disease Associates
City
Council Bluffs
State/Province
Iowa
ZIP/Postal Code
51503
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Tulane Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Massachusetts General Hospital, Division of Pulmonary and Critical Care Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Caritas St. Elizabeth's Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Henry Ford Health System
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48124
Country
United States
Facility Name
Minnesota Lung Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Mayo Clinic - PPDS
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Creighton University
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
University of Rochester Medical Center - PPDS
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
PulmonIx LLC
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Facility Name
UC Health Department of Internal Medicine, Pulmonary, Critical Care & Sleep Medicine
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195-0001
Country
United States
Facility Name
The Oregon Clinic
City
Portland
State/Province
Oregon
ZIP/Postal Code
97220
Country
United States
Facility Name
Penn State Milton S Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Metroplex Pulmonary and Sleep Medicine Center
City
McKinney
State/Province
Texas
ZIP/Postal Code
75069
Country
United States
Facility Name
University of Texas Health Science Center San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University of Utah Medical Care
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Western Washington Medical Group
City
Everett
State/Province
Washington
ZIP/Postal Code
98208
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Royal Adelaide Hospital
City
Adelaide
ZIP/Postal Code
5000
Country
Australia
Facility Name
Flinders Medical Centre
City
Bedford Park
ZIP/Postal Code
5042
Country
Australia
Facility Name
Box Hill Hospital
City
Box Hill
ZIP/Postal Code
VIC 3128
Country
Australia
Facility Name
Corte Royal Prince Alfred Hospital
City
Camperdown
ZIP/Postal Code
NSW 2050
Country
Australia
Facility Name
Lung Research Queensland
City
Chermside
ZIP/Postal Code
QLD 4060
Country
Australia
Facility Name
Concord Repatriation General Hospital
City
Concord
ZIP/Postal Code
NSW 2139
Country
Australia
Facility Name
St Vincent's Hospital Sydney
City
Darlinghurst
ZIP/Postal Code
NSW 2010
Country
Australia
Facility Name
Austin Health
City
Heidelberg
ZIP/Postal Code
3084
Country
Australia
Facility Name
Respiratory Clinical Trials Pty Ltd
City
Kent Town
ZIP/Postal Code
SA 5067
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
ZIP/Postal Code
VIC 3004
Country
Australia
Facility Name
ZNA Middelheim
City
Antwerp
ZIP/Postal Code
2020
Country
Belgium
Facility Name
Hôpital Erasme
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
CHU UCL Namur asbl - Site Godinne
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
Irmandade Da Santa Casa de Misericordia de Porto Alegre
City
Porto Alegre
ZIP/Postal Code
90035-074
Country
Brazil
Facility Name
Faculdade de Medicina Do ABC
City
Santo André
ZIP/Postal Code
09060-870
Country
Brazil
Facility Name
Hospital Clínico Regional de Concepción Dr Guillermo Grant Benavente
City
Concepción
ZIP/Postal Code
4070038
Country
Chile
Facility Name
Centro de Investigación Curico
City
Curicó
ZIP/Postal Code
3341643
Country
Chile
Facility Name
Centro Respiratorio Integral LTDA. (CENRESIN)
City
Quillota
ZIP/Postal Code
2260000
Country
Chile
Facility Name
Instituto Nacional Torax
City
Santiago
ZIP/Postal Code
7500691
Country
Chile
Facility Name
Centro de Investigaciones Medicas Respiratorias CIMER
City
Santiago
ZIP/Postal Code
7500692
Country
Chile
Facility Name
Hospital Dr Sotero Del Rio
City
Santiago
ZIP/Postal Code
8207257
Country
Chile
Facility Name
Centro de Investigacion del Maule
City
Talca
ZIP/Postal Code
3465584
Country
Chile
Facility Name
Hospital Carlos Van Buren
City
Valparaíso
ZIP/Postal Code
2352499
Country
Chile
Facility Name
CINVEC- Estudos Clínicos Quinta Región Limitada
City
Viña Del Mar
ZIP/Postal Code
2520024
Country
Chile
Facility Name
Fakultni nemocnice Brno
City
Brno
ZIP/Postal Code
62500
Country
Czechia
Facility Name
Fakultni nemocnice Ostrava
City
Ostrava
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Thomayerova nemocnice
City
Praha
ZIP/Postal Code
14059
Country
Czechia
Facility Name
Nemocnice Na Bulovce
City
Praha
ZIP/Postal Code
180 81
Country
Czechia
Facility Name
Aarhus Universitetshospital
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Gentofte Hospital
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark
Facility Name
Odense Universitetshospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Zentralklinik Bad Berka GmbH
City
Bad Berka
ZIP/Postal Code
99437
Country
Germany
Facility Name
Evangelische Lungenklinik
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Fachkrankenhaus Coswig
City
Coswig
ZIP/Postal Code
01640
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Thorax Klinik
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
Universitatsklinikum Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Klinikum Rosenheim
City
Rosenheim
ZIP/Postal Code
83022
Country
Germany
Facility Name
Sotiria Chest Hospital of Athens
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Attikon University General Hospital
City
Athens
ZIP/Postal Code
12464
Country
Greece
Facility Name
University General Hospital of Heraklion
City
Iraklio
ZIP/Postal Code
71110
Country
Greece
Facility Name
University General Hospital of Larissa
City
Larissa
ZIP/Postal Code
41110
Country
Greece
Facility Name
Georgios Papanikolaou General Hospital of Thessaloniki
City
Thessaloníki
ZIP/Postal Code
57010
Country
Greece
Facility Name
Tenryu Hospital
City
Hamamatsu
ZIP/Postal Code
434-8511
Country
Japan
Facility Name
Saiseikai Kumamoto Hospital
City
Kumamoto
ZIP/Postal Code
861-4193
Country
Japan
Facility Name
National Hospital Organization Kinki-Chuo Chest Medical Center
City
Sakai
ZIP/Postal Code
591-8555
Country
Japan
Facility Name
Tosei General Hospital
City
Seto
ZIP/Postal Code
489-0065
Country
Japan
Facility Name
Center Hospital of the National Center for Global Health and Medicine
City
Tokyo
ZIP/Postal Code
162-0052
Country
Japan
Facility Name
National Hospital Organization Kyushu Medical Center
City
Tokyo
ZIP/Postal Code
810-8563
Country
Japan
Facility Name
Kanagawa Cardiovascular and Respiratory Center
City
Yokohama
ZIP/Postal Code
236-0051
Country
Japan
Facility Name
Hospital Chancay y Servicios Basicos de Salud
City
Chancay
ZIP/Postal Code
15131
Country
Peru
Facility Name
Clinica Internacional - PPDS
City
Lima Cercado
Country
Peru
Facility Name
Hospital Nacional Guillermo Almenara Irigoyen ESSALUD
City
Lima
Country
Peru
Facility Name
Clinica Ricardo Palma - PPDS
City
San Isidro
Country
Peru
Facility Name
Clinica Providencia (Inverconsult Sociedad Anonima)
City
San Miguel
Country
Peru
Facility Name
Clinica San Pablo
City
Santiago De Surco
Country
Peru
Facility Name
CHUVI - H.U. Alvaro Cunquerio
City
Vigo
State/Province
Pontevedra
ZIP/Postal Code
36312
Country
Spain
Facility Name
Hospital Clinical de Barcelona
City
Barcelona
ZIP/Postal Code
03036
Country
Spain
Facility Name
Hospital Universitario de Bellvitge, Hospitalet De Llobregat
City
Barcelona
ZIP/Postal Code
08097
Country
Spain
Facility Name
Hospital Universitario de La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Clinica Universidad Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Universitario Marques de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Consorcio Hospital General Universitario de Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Kaohsiung Medical University Hospital
City
Kaohsiung City
ZIP/Postal Code
807
Country
Taiwan
Facility Name
Far Eastern Memorial Hospital
City
New Taipei City
ZIP/Postal Code
220
Country
Taiwan
Facility Name
Taipei Medical University Shuang Ho Hospital
City
New Taipei City
ZIP/Postal Code
23561
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Süreyyapaşa Göğüs Hastalıkları Ve Göğüs Cerrahisi Eğitim Ve Araştırma Hastanesi
City
Istanbul
ZIP/Postal Code
34854
Country
Turkey
Facility Name
Ege Universitesi Tıp Fakultesi Hastanesi Gögus Hastalıkları Anabilim Dalı
City
İzmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Uludag Universitesi Tıp Fakultesi Hastanesi Gögüs Hastalıkları Anabilim Dalı
City
İzmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Mersin Üniversitesi Tıp Fakültesi Hastanesi Göğüs Hastalıkları Polikinliği
City
Mersin
ZIP/Postal Code
33169
Country
Turkey
Facility Name
Birmingham Heartlands Hospital
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Southmead Hospital
City
Bristol
ZIP/Postal Code
BS10 5NB
Country
United Kingdom
Facility Name
Papworth Hospital
City
Cambridge
ZIP/Postal Code
CB233RE
Country
United Kingdom
Facility Name
Castle Hill Hospital
City
Cottingham
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
Facility Name
Royal Devon and Exeter Hospital NHS Trust
City
Exeter
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
Aintree University Hospital NHS Foundation Trust
City
Liverpool
ZIP/Postal Code
L9 7AL
Country
United Kingdom
Facility Name
Royal Brompton Hospital
City
London
ZIP/Postal Code
SW3 6NP
Country
United Kingdom
Facility Name
Wythenshawe Hospital - PPDS
City
Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom
Facility Name
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
City
Newcastle
ZIP/Postal Code
NE14LP
Country
United Kingdom
Facility Name
Nottingham City Hospital
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Northern General Hospital
City
Sheffield
ZIP/Postal Code
S5 7AU
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31179008
Citation
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.
Results Reference
derived

Learn more about this trial

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

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