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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 (ISABELA2)

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ClinicalTrials.gov Identifier: NCT03733444
Recruitment Status : Recruiting
First Posted : November 7, 2018
Last Update Posted : October 7, 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 the 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, Multi-center 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 5, 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.

Experimental: Placebo
Placebo to match will be administered as matching 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): NCT03733444


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
Arizona Pulmonary Specialists Recruiting
Phoenix, Arizona, United States, 85012
University of Arizona College of Medicine Recruiting
Tucson, Arizona, United States, 85724
United States, California
Keck School of Medicine of USC Recruiting
Los Angeles, California, United States, 90033
University of California, San Francisco Medical Center Recruiting
San Francisco, California, United States, 94143
United States, Florida
St. Francis Medical Institute Recruiting
Clearwater, Florida, United States, 33765
University of Miami Recruiting
Miami, Florida, United States, 33136
Renstar Medical Research Recruiting
Ocala, Florida, United States, 34470
Central Florida Pulmonary Group PA Recruiting
Orlando, Florida, United States, 32803
United States, Georgia
Piedmont Healthcare Recruiting
Atlanta, Georgia, United States, 30309
United States, Illinois
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
United States, Michigan
University of Michigan Health System (UMHS) Recruiting
Ann Arbor, Michigan, United States, 48109
Spectrum Health Medical Group Recruiting
Grand Rapids, Michigan, United States, 49546
United States, Minnesota
University of Minnesota Medical Center Recruiting
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Cardio Pulmonary Associates Recruiting
Chesterfield, Missouri, United States, 63017
United States, New Hampshire
Dartmouth Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03765
United States, New Jersey
Atlantic Respiratory Institute Recruiting
Summit, New Jersey, United States, 07901
United States, New Mexico
Lovelace Scientific Resources Inc Recruiting
Albuquerque, New Mexico, United States, 87108
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
United States, Ohio
Ohio State University Recruiting
Columbus, Ohio, United States, 43203
Mercy Health - St. Vincent Medical Center Recruiting
Toledo, Ohio, United States, 43608
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Temple Lung Center Recruiting
Philadelphia, Pennsylvania, United States, 19140
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Medical University of South Carolina - PPDS Recruiting
Charleston, South Carolina, United States, 29425
United States, Vermont
University of Vermont Recruiting
Burlington, Vermont, United States, 05401
United States, Virginia
Inova Fairfax Hospital Recruiting
Falls Church, Virginia, United States, 22042
Argentina
Centro Médico Dra de Salvo Recruiting
Buenos Aires, Argentina, C1426ABP
Hospital Privado Centro Médico de Córdoba Recruiting
Córdoba, Argentina, X5016KEH
CEMER Centro Médico de Enfermedades Respiratorias Recruiting
Florida, Argentina, B1602DQD
Instituto de Investigaciones Clínicas Mar Del Plata Recruiting
Mar Del Plata, Argentina, B7600FZN
Fundacion Scherbovsky Recruiting
Mendoza, Argentina, 5500
Canada
Hôtel Dieu Du Centre Hospitalier de L'université de Montréal Recruiting
Montréal, Canada, H2L 4M1
McGill University Health Centre Research Institute Recruiting
Montréal, Canada, QC H3S 1Y9
Institut Universitaire de Cardiologie et de Pneumologie Recruiting
Québec, Canada, G1V 4G5
Toronto General Hospital Recruiting
Toronto, Canada, M5G 2N2
Vancouver General Hospital Recruiting
Vancouver, Canada, V5Z 1M9
Pacific Lung Research Center Recruiting
Vancouver, Canada, V6Z 1Y6
Dr Anil Dhar Professional Medicine Corporation Recruiting
Windsor, Canada, N8W1L9
France
Hôpital Nord AP-HM Recruiting
Marseille, France, 13915
Centre Hospitalier Regional Universitaire Montpellier Recruiting
Montpellier, France, 34295
Groupe Hospitalier Bichat Claude Bernard Recruiting
Paris, France, 75018
CHU de Reims Recruiting
Reims, France, 51092
Germany
Ruhrlandklinik Recruiting
Essen, Germany, 45239
Praxis Dr. med. Claus Keller Recruiting
Frankfurt, Germany, 60389
Pneumologisches Forschungsinstitut Recruiting
Großhansdorf, Germany, 22927
Lungenfachklinik Immenhausen Recruiting
Immenhausen, Germany, 34376
Krankenhaus Bethanien - Klinik für Pneumologie und Allergologie Recruiting
Solingen, Germany, 42699
Hungary
Semmelweis Egyetem Recruiting
Budapest, Hungary, 1125
Veszprem Megyei Tudogyogyintezet Recruiting
Farkasgyepű, Hungary, 8582
Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktató Kórház Recruiting
Miskolc, Hungary, 3529
Tüdőgyógyintézet Törökbálint Recruiting
Törökbálint, Hungary, 2045
Israel
Barzilai Medical Center Recruiting
Ashkelon, Israel, 78278
Lady Davis Carmel Medical Center Recruiting
Haifa, Israel, 34362
Hadassah University Hospital Ein Kerem Recruiting
Jerusalem, Israel, 91120
Meir Medical Center Recruiting
Kfar Saba, Israel, 44281
Rabin Medical Center - PPDS Recruiting
Petah tikva, Israel, 49100
Kaplan Medical Center Recruiting
Reẖovot, Israel, 7661041
Italy
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele Recruiting
Catania, Sicilia, Italy, 95123
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi Recruiting
Ancona, Italy, 60020
Presidio Ospedaliero GB Morgagni L Pierantoni Recruiting
Forlì, Italy, 47121
Ospedale S. Giuseppe Multimedica Recruiting
Milano, Italy, 20123
Università Cattolica Del S Cuore Recruiting
Roma, Italy, 00168
Azienda Ospedaliera Universitaria Senese Recruiting
Siena, Italy, 53100
Korea, Republic of
Soon Chun Hyang University Hospital Bucheon Recruiting
Bucheon, Gyeonggi-do, Korea, Republic of, 420-767
Seoul National University Bundang Hospital Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Gachon University Gil Medical Center Recruiting
Incheon, Korea, Republic of, 405760
Asan Medical Center - PPDS Recruiting
Seoul, Korea, Republic of, 05505
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-170
Soon Chun Hyang University Hospital Seoul Recruiting
Seoul, Korea, Republic of, 140-743
Mexico
Centro de Investigación Medico Biologica y de Terapia Avanzada S.C. Recruiting
Guadalajara, Mexico, 44130
Hospital Universitatorio Dr. Jose Eleuterio González Recruiting
Monterrey, Mexico, 64460
Unidad de Investigación Clínica En Medicina SC Recruiting
Monterrey, Mexico, 64718
Netherlands
VU Medisch Centrum Recruiting
Amsterdam, Netherlands, 1081 HV
OLVG locatie Oost Recruiting
Amsterdam, Netherlands, 1091 AC
Martini Ziekenhuis Recruiting
Groningen, Netherlands, 9700 RM
Zuyderland Medisch Centrum Recruiting
Heerlen, Netherlands, 6419 PC
St. Antonius Ziekenhuis Recruiting
Nieuwegein, Netherlands, 3425 CM
Erasmus MC Recruiting
Rotterdam, Netherlands, 3015 GD
New Zealand
Greenlane Clinical Centre Recruiting
Auckland, New Zealand, 1051
NZ Respiratory & Sleep Institute Recruiting
Auckland, New Zealand, 1149
Christchurch Hospital Recruiting
Christchurch, New Zealand, 8011
Waikato Hospital Recruiting
Hamilton, New Zealand, 3204
Poland
Centrum Medycyny Oddechowej Mroz sp. j. Recruiting
Białystok, Poland, 15-044
Uniwersyteckie Centrum Kliniczne - PPDS Recruiting
Gdańsk, Poland, 80-952
PULMAG Arkadiusz Brodowski, Grzegorz Gasior S. C. Recruiting
Katowice, Poland, 40-753
SP ZOZ Szpital Uniwersytecki w Krakowie Recruiting
Kraków, Poland, 31-153
GRAŻYNA JASIENIAK-PINIS ATOPIA Niepubliczny Zakład Opieki Zdrowotnej Poradnie Specjalistyczne Recruiting
Kraków, Poland, 31-159
ETG Lublin Recruiting
Lublin, Poland, 20-314
ETG Warszawa Recruiting
Warszawa, Poland, 02-777
SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im Norberta Barlickiego Uniwersytetu Medycznego w Lodzi Recruiting
Łódź, Poland, 90-153
South Africa
Tygerberg Hospital Recruiting
Cape Town, South Africa, 7505
University of Cape Town Lung Institute (UCTLI) Recruiting
Cape Town, South Africa, 7700
Dr Ismail Abdullah Private Practice Recruiting
Cape Town, South Africa, 7764
Ethekwini Hospital Recruiting
Durban, South Africa, 4017
Gateway Private Hospital Recruiting
Durban, South Africa, 4091
Milpark Hospital Recruiting
Johannesburg, South Africa, 2193
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: NCT03733444     History of Changes
Other Study ID Numbers: GLPG1690-CL-304
2018-001406-29 ( EudraCT Number )
First Posted: November 7, 2018    Key Record Dates
Last Update Posted: October 7, 2019
Last Verified: October 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