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Trial record 3 of 6 for:    IPF Cleveland Clinic | Recruiting, Not yet recruiting, Available Studies

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03711162
Recruitment Status : Recruiting
First Posted : October 18, 2018
Last Update Posted : November 11, 2019
Sponsor:
Information provided by (Responsible Party):
Galapagos NV

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

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Drug: GLPG1690 Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : November 28, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021


Arm Intervention/treatment
Experimental: GLPG1690 Dose A
GLPG1690 will be administered as film-coated tablets for oral use once daily.
Drug: GLPG1690
GLPG1690, film-coated tablets for oral use.

Experimental: GLPG1690 Dose B
GLPG1690 will be administered as film-coated tablets for oral use once daily.
Drug: GLPG1690
GLPG1690, film-coated tablets for oral use.

Placebo Comparator: Placebo
Placebo to match will be administered as film-coated tablets for oral use once daily.
Drug: Placebo
Matching placebo, film-coated tablets for oral use.




Primary Outcome Measures :
  1. Rate of decline of forced vital capacity (FVC) in mL. [ Time Frame: From baseline through week 52 ]
    To evaluate the efficacy of two doses of GLPG1690 in addition to local standard of care compared to placebo in subjects with Idiopathic Pulmonary Fibrosis (IPF) as evaluated by the rate of decline of FVC.


Secondary Outcome Measures :
  1. Disease progression defined as the composite endpoint of first occurrence of ≥10% absolute decline in percent predicted forced vital capacity (%FVC) or all-cause mortality. [ Time Frame: At week 52 ]
    To evaluate the impact of two doses of GLPG1690 in addition to local standard of care compared to placebo in subjects with Idiopathic Pulmonary Fibrosis (IPF) on disease progression defined as deterioration of FVC or all-cause mortality.

  2. Time to first respiratory-related hospitalization until the end of the study [ Time Frame: From screening through study completion, a minimum of 52 weeks ]
    To evaluate the impact of two doses of GLPG1690 in addition to local standard of care compared to placebo in subjects with Idiopathic Pulmonary Fibrosis (IPF) on respiratory-related hospitalization until the end of the study.

  3. Change from baseline in the St. George's Respiratory Questionnaire (SGRQ) total score. [ Time Frame: At week 52 ]
    To evaluate the impact of two doses of GLPG1690 in addition to local standard of care compared to placebo in subjects with Idiopathic Pulmonary Fibrosis (IPF) on changes in quality of life (measured by SGRQ total score).The SGRQ is a 50-item questionnaire split into three domains: symptoms, activity and impact. Scores are weighted such that every domain score and the total score range from 0 to 100, with higher scores indicating a poorer health-related quality of life.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
  • 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 antibiotics 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03711162


Contacts
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Contact: Galapagos Medical Information +32 15 342900 medicalinfo@glpg.com

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Locations
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United States, Arizona
Pulmonary Associates Recruiting
Phoenix, Arizona, United States, 85006
Mayo Clinic Arizona - PPDS Recruiting
Scottsdale, Arizona, United States, 85259
United States, California
David Geffen School of Medicine at UCLA Recruiting
Los Angeles, California, United States, 90095
University of California San Diego Recruiting
San Diego, California, United States, 92037
United States, Colorado
University of Colorado Recruiting
Aurora, Colorado, United States, 80045
National Jewish Health Recruiting
Denver, Colorado, United States, 80206
United States, Connecticut
Western Connecticut Medical Group Recruiting
Danbury, Connecticut, United States, 06810
Yale University School of Medicine Recruiting
New Haven, Connecticut, United States, 06510
United States, District of Columbia
MedStar Georgetown University Hospital Recruiting
Washington, District of Columbia, United States, 20007
United States, Florida
PAB Clinical Research - ClinEdge - PPDS Recruiting
Brandon, Florida, United States, 33511
University of Florida Recruiting
Gainesville, Florida, United States, 32610
United States, Illinois
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
Stanford University Medical Center Recruiting
Chicago, Illinois, United States, 60611
United States, Iowa
Pulmonary and Infections Disease Associates Recruiting
Council Bluffs, Iowa, United States, 51503
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
United States, Louisiana
Tulane Medical Center Recruiting
New Orleans, Louisiana, United States, 70112
United States, Maryland
University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Caritas St. Elizabeth's Medical Center Recruiting
Boston, Massachusetts, United States, 02135
United States, Michigan
Henry Ford Health System Recruiting
Dearborn, Michigan, United States, 48124
United States, Minnesota
Minnesota Lung Center Recruiting
Minneapolis, Minnesota, United States, 55407
Mayo Clinic - PPDS Recruiting
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
United States, Nebraska
Creighton University Recruiting
Omaha, Nebraska, United States, 68131
United States, North Carolina
PulmonIx LLC Recruiting
Greensboro, North Carolina, United States, 27403
United States, Ohio
UC Health Department of Internal Medicine, Pulmonary, Critical Care & Sleep Medicine Recruiting
Cincinnati, Ohio, United States, 45267
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195-0001
United States, Oregon
The Oregon Clinic Recruiting
Portland, Oregon, United States, 97220
United States, Pennsylvania
Penn State Milton S Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
United States, Texas
Houston Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Metroplex Pulmonary and Sleep Medicine Center Recruiting
McKinney, Texas, United States, 75069
University of Texas Health Science Center San Antonio Recruiting
San Antonio, Texas, United States, 78229
United States, Utah
University of Utah Medical Care Recruiting
Salt Lake City, Utah, United States, 84108
United States, Washington
University of Washington Medical Center Recruiting
Seattle, Washington, United States, 98195
United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53792
Australia
Royal Adelaide Hospital Recruiting
Adelaide, Australia, 5000
Flinders Medical Centre Recruiting
Bedford Park, Australia, 5042
Box Hill Hospital Recruiting
Box Hill, Australia, VIC 3128
Corte Royal Prince Alfred Hospital Recruiting
Camperdown, Australia, NSW 2050
Lung Research Queensland Recruiting
Chermside, Australia, QLD 4060
Concord Repatriation General Hospital Recruiting
Concord, Australia, NSW 2139
St Vincent's Hospital Sydney Recruiting
Darlinghurst, Australia, NSW 2010
Austin Health Recruiting
Heidelberg, Australia, 3084
Respiratory Clinical Trials Pty Ltd Recruiting
Kent Town, Australia, SA 5067
The Alfred Hospital Recruiting
Melbourne, Australia, VIC 3004
Belgium
ZNA Middelheim Recruiting
Antwerp, Belgium, 2020
Hôpital Erasme Recruiting
Brussels, Belgium, 1070
Cliniques Universitaires Saint-Luc Recruiting
Brussels, Belgium, 1200
UZ Leuven Recruiting
Leuven, Belgium, 3000
CHU UCL Namur asbl - Site Godinne Recruiting
Yvoir, Belgium, 5530
Chile
Hospital Clínico Regional de Concepción Dr Guillermo Grant Benavente Recruiting
Concepción, Chile, 4070038
Instituto Nacional Torax Recruiting
Santiago, Chile, 7500691
Hospital Dr Sotero Del Rio Recruiting
Santiago, Chile, 8207257
Centro de Investigacion del Maule Recruiting
Talca, Chile, 3465584
Hospital Carlos Van Buren Recruiting
Valparaíso, Chile, 2352499
CINVEC- Estudos Clínicos Quinta Región Limitada Recruiting
Viña Del Mar, Chile, 2520024
Czechia
Fakultni nemocnice Brno Recruiting
Brno, Czechia, 62500
Fakultni nemocnice Ostrava Recruiting
Ostrava, Czechia, 708 52
Thomayerova nemocnice Recruiting
Praha, Czechia, 14059
Nemocnice Na Bulovce Recruiting
Praha, Czechia, 180 81
Denmark
Aarhus Universitetshospital Recruiting
Aarhus, Denmark, 8200
Gentofte Hospital Recruiting
Hellerup, Denmark, 2900
Odense Universitetshospital Recruiting
Odense, Denmark, 5000
Germany
Zentralklinik Bad Berka GmbH Recruiting
Bad Berka, Germany, 99437
Evangelische Lungenklinik Recruiting
Berlin, Germany, 13125
Fachkrankenhaus Coswig Recruiting
Coswig, Germany, 01640
Medizinische Hochschule Hannover Recruiting
Hannover, Germany, 30625
Thorax Klinik Recruiting
Heidelberg, Germany, 69126
Universitatsklinikum Leipzig Recruiting
Leipzig, Germany, 04103
Klinikum Rosenheim Recruiting
Rosenheim, Germany, 83022
Greece
Sotiria Chest Hospital of Athens Recruiting
Athens, Greece, 11527
Attikon University General Hospital Recruiting
Athens, Greece, 12464
University General Hospital of Heraklion Recruiting
Iraklio, Greece, 71110
University General Hospital of Larissa Recruiting
Larissa, Greece, 41110
Georgios Papanikolaou General Hospital of Thessaloniki Recruiting
Thessaloníki, Greece, 57010
Peru
Clinica Internacional - PPDS Recruiting
Lima Cercado, Peru
Clinica Ricardo Palma - PPDS Recruiting
San Isidro, Peru
Clinica Providencia (Inverconsult Sociedad Anonima) Recruiting
San Miguel, Peru
Clinica San Pablo Recruiting
Santiago De Surco, Peru
Spain
CHUVI - H.U. Alvaro Cunquerio Recruiting
Vigo, Pontevedra, Spain, 36312
Hospital Clinical de Barcelona Recruiting
Barcelona, Spain, 03036
Hospital Universitario de Bellvitge, Hospitalet De Llobregat Recruiting
Barcelona, Spain, 08097
Hospital Universitario de La Princesa Recruiting
Madrid, Spain, 28006
Hospital Clinico San Carlos Recruiting
Madrid, Spain, 28040
Clinica Universidad Navarra Recruiting
Pamplona, Spain, 31008
Hospital Universitario Marques de Valdecilla Recruiting
Santander, Spain, 39008
Consorcio Hospital General Universitario de Valencia Recruiting
Valencia, Spain, 46014
Taiwan
Kaohsiung Medical University Hospital Recruiting
Kaohsiung City, Taiwan, 807
Far Eastern Memorial Hospital Recruiting
New Taipei City, Taiwan, 220
Taipei Medical University Shuang Ho Hospital Recruiting
New Taipei City, Taiwan, 23561
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10002
Turkey
Süreyyapaşa Göğüs Hastalıkları Ve Göğüs Cerrahisi Eğitim Ve Araştırma Hastanesi Recruiting
Istanbul, Turkey, 34854
Ege Universitesi Tıp Fakultesi Hastanesi Gögus Hastalıkları Anabilim Dalı Recruiting
İzmir, Turkey, 35100
Uludag Universitesi Tıp Fakultesi Hastanesi Gögüs Hastalıkları Anabilim Dalı Recruiting
İzmir, Turkey, 35100
Mersin Üniversitesi Tıp Fakültesi Hastanesi Göğüs Hastalıkları Polikinliği Recruiting
Mersin, Turkey, 33169
United Kingdom
Birmingham Heartlands Hospital Recruiting
Birmingham, United Kingdom, B9 5SS
Southmead Hospital Recruiting
Bristol, United Kingdom, BS10 5NB
Papworth Hospital Recruiting
Cambridge, United Kingdom, CB233RE
Castle Hill Hospital Recruiting
Cottingham, United Kingdom, HU16 5JQ
Royal Devon and Exeter Hospital NHS Trust Recruiting
Exeter, United Kingdom, EX2 5DW
Aintree University Hospital NHS Foundation Trust Recruiting
Liverpool, United Kingdom, L9 7AL
Royal Brompton Hospital Recruiting
London, United Kingdom, SW3 6NP
Wythenshawe Hospital - PPDS Recruiting
Manchester, United Kingdom, M23 9LT
The Newcastle Upon Tyne Hospitals NHS Foundation Trust Recruiting
Newcastle, United Kingdom, NE14LP
Nottingham City Hospital Recruiting
Nottingham, United Kingdom, NG5 1PB
Northern General Hospital Recruiting
Sheffield, United Kingdom, S5 7AU
Sponsors and Collaborators
Galapagos NV
Investigators
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Study Director: Ann Fieuw, MD, MSc Galapagos NV

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Galapagos NV
ClinicalTrials.gov Identifier: NCT03711162     History of Changes
Other Study ID Numbers: GLPG1690-CL-303
2018-001405-87 ( EudraCT Number )
First Posted: October 18, 2018    Key Record Dates
Last Update Posted: November 11, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial