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

Study Purpose

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).

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Study Type
Interventional
Eligible Ages 40 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT03733444

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
Phase 3

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Galapagos NV

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Ann Fieuw, MD, MSc
Principal Investigator Affiliation Galapagos NV

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Industry
Overall Status Recruiting
Countries Argentina, Canada, France, Germany, Hungary, Israel, Italy, Korea, Republic of, Netherlands, New Zealand, Poland, South Africa, United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Idiopathic Pulmonary Fibrosis

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Inova Fairfax Hospital, Falls Church, Virginia

Status

Recruiting

Address

Inova Fairfax Hospital

Falls Church, Virginia, 22042

Charleston, South Carolina

Status

Recruiting

Address

Medical University of South Carolina - PPDS

Charleston, South Carolina, 29425

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania

Status

Recruiting

Address

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213

Temple Lung Center, Philadelphia, Pennsylvania

Status

Recruiting

Address

Temple Lung Center

Philadelphia, Pennsylvania, 19140

Thomas Jefferson University, Philadelphia, Pennsylvania

Status

Recruiting

Address

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107

Toledo, Ohio

Status

Recruiting

Address

Mercy Health - St. Vincent Medical Center

Toledo, Ohio, 43608

Ohio State University, Columbus, Ohio

Status

Recruiting

Address

Ohio State University

Columbus, Ohio, 43203

Columbia University Medical Center, New York, New York

Status

Recruiting

Address

Columbia University Medical Center

New York, New York, 10032

Lovelace Scientific Resources Inc, Albuquerque, New Mexico

Status

Recruiting

Address

Lovelace Scientific Resources Inc

Albuquerque, New Mexico, 87108

Atlantic Respiratory Institute, Summit, New Jersey

Status

Recruiting

Address

Atlantic Respiratory Institute

Summit, New Jersey, 07901

Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire

Status

Recruiting

Address

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03765

Cardio Pulmonary Associates, Chesterfield, Missouri

Status

Recruiting

Address

Cardio Pulmonary Associates

Chesterfield, Missouri, 63017

University of Minnesota Medical Center, Minneapolis, Minnesota

Status

Recruiting

Address

University of Minnesota Medical Center

Minneapolis, Minnesota, 55455

Ann Arbor, Michigan

Status

Recruiting

Address

University of Michigan Health System (UMHS)

Ann Arbor, Michigan, 48109

University of Kansas Medical Center, Kansas City, Kansas

Status

Recruiting

Address

University of Kansas Medical Center

Kansas City, Kansas, 66160

Piedmont Healthcare, Atlanta, Georgia

Status

Recruiting

Address

Piedmont Healthcare

Atlanta, Georgia, 30309

Central Florida Pulmonary Group PA, Orlando, Florida

Status

Recruiting

Address

Central Florida Pulmonary Group PA

Orlando, Florida, 32803

Renstar Medical Research, Ocala, Florida

Status

Recruiting

Address

Renstar Medical Research

Ocala, Florida, 34470

University of Miami, Miami, Florida

Status

Recruiting

Address

University of Miami

Miami, Florida, 33136

St. Francis Medical Institute, Clearwater, Florida

Status

Recruiting

Address

St. Francis Medical Institute

Clearwater, Florida, 33765

Arizona Pulmonary Specialists, Phoenix, Arizona

Status

Recruiting

Address

Arizona Pulmonary Specialists

Phoenix, Arizona, 85012

International Sites

Gateway Private Hospital, Durban, South Africa

Status

Recruiting

Address

Gateway Private Hospital

Durban, , 4091

Dr Ismail Abdullah Private Practice, Cape Town, South Africa

Status

Recruiting

Address

Dr Ismail Abdullah Private Practice

Cape Town, , 7764

Łódź, Poland

Status

Recruiting

Address

SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im Norberta Barlickiego Uniwersytetu Medycznego w Lodzi

Łódź, , 90-153

ETG Warszawa, Warszawa, Poland

Status

Recruiting

Address

ETG Warszawa

Warszawa, , 02-777

ETG Lublin, Lublin, Poland

Status

Recruiting

Address

ETG Lublin

Lublin, , 20-314

Kraków, Poland

Status

Recruiting

Address

GRAŻYNA JASIENIAK-PINIS ATOPIA Niepubliczny Zakład Opieki Zdrowotnej Poradnie Specjalistyczne

Kraków, , 31-159

Katowice, Poland

Status

Recruiting

Address

PULMAG Arkadiusz Brodowski, Grzegorz Gasior S. C.

Katowice, , 40-753

Uniwersyteckie Centrum Kliniczne - PPDS, Gdańsk, Poland

Status

Recruiting

Address

Uniwersyteckie Centrum Kliniczne - PPDS

Gdańsk, , 80-952

Centrum Medycyny Oddechowej Mroz sp. j., Białystok, Poland

Status

Recruiting

Address

Centrum Medycyny Oddechowej Mroz sp. j.

Białystok, , 15-044

Waikato Hospital, Hamilton, New Zealand

Status

Recruiting

Address

Waikato Hospital

Hamilton, , 3204

Christchurch Hospital, Christchurch, New Zealand

Status

Recruiting

Address

Christchurch Hospital

Christchurch, , 8011

NZ Respiratory & Sleep Institute, Auckland, New Zealand

Status

Recruiting

Address

NZ Respiratory & Sleep Institute

Auckland, , 1149

Greenlane Clinical Centre, Auckland, New Zealand

Status

Recruiting

Address

Greenlane Clinical Centre

Auckland, , 1051

Erasmus MC, Rotterdam, Netherlands

Status

Recruiting

Address

Erasmus MC

Rotterdam, , 3015 GD

St. Antonius Ziekenhuis, Nieuwegein, Netherlands

Status

Recruiting

Address

St. Antonius Ziekenhuis

Nieuwegein, , 3425 CM

Zuyderland Medisch Centrum, Heerlen, Netherlands

Status

Recruiting

Address

Zuyderland Medisch Centrum

Heerlen, , 6419 PC

Martini Ziekenhuis, Groningen, Netherlands

Status

Recruiting

Address

Martini Ziekenhuis

Groningen, , 9700 RM

VU Medisch Centrum, Amsterdam, Netherlands

Status

Recruiting

Address

VU Medisch Centrum

Amsterdam, , 1081 HV

Seoul, Korea, Republic of

Status

Recruiting

Address

Soon Chun Hyang University Hospital Seoul

Seoul, , 140-743

Samsung Medical Center, Seoul, Korea, Republic of

Status

Recruiting

Address

Samsung Medical Center

Seoul, , 135-170

Asan Medical Center - PPDS, Seoul, Korea, Republic of

Status

Recruiting

Address

Asan Medical Center - PPDS

Seoul, , 05505

Gachon University Gil Medical Center, Incheon, Korea, Republic of

Status

Recruiting

Address

Gachon University Gil Medical Center

Incheon, , 405760

Seongnam-si, Gyeonggi-do, Korea, Republic of

Status

Recruiting

Address

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707

Bucheon, Gyeonggi-do, Korea, Republic of

Status

Recruiting

Address

Soon Chun Hyang University Hospital Bucheon

Bucheon, Gyeonggi-do, 420-767

Azienda Ospedaliera Universitaria Senese, Siena, Italy

Status

Recruiting

Address

Azienda Ospedaliera Universitaria Senese

Siena, , 53100

Università Cattolica Del S Cuore, Roma, Italy

Status

Recruiting

Address

Università Cattolica Del S Cuore

Roma, , 00168

Ospedale S. Giuseppe Multimedica, Milano, Italy

Status

Recruiting

Address

Ospedale S. Giuseppe Multimedica

Milano, , 20123

Ancona, Italy

Status

Recruiting

Address

Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi

Ancona, , 60020

Catania, Sicilia, Italy

Status

Recruiting

Address

Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele

Catania, Sicilia, 95123

Kaplan Medical Center, Reẖovot, Israel

Status

Recruiting

Address

Kaplan Medical Center

Reẖovot, , 7661041

Rabin Medical Center - PPDS, Petah tikva, Israel

Status

Recruiting

Address

Rabin Medical Center - PPDS

Petah tikva, , 49100

Meir Medical Center, Kfar Saba, Israel

Status

Recruiting

Address

Meir Medical Center

Kfar Saba, , 44281

Hadassah University Hospital Ein Kerem, Jerusalem, Israel

Status

Recruiting

Address

Hadassah University Hospital Ein Kerem

Jerusalem, , 91120

Lady Davis Carmel Medical Center, Haifa, Israel

Status

Recruiting

Address

Lady Davis Carmel Medical Center

Haifa, , 34362

Barzilai Medical Center, Ashkelon, Israel

Status

Recruiting

Address

Barzilai Medical Center

Ashkelon, , 78278

Tüdőgyógyintézet Törökbálint, Törökbálint, Hungary

Status

Recruiting

Address

Tüdőgyógyintézet Törökbálint

Törökbálint, , 2045

Miskolc, Hungary

Status

Recruiting

Address

Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktató Kórház

Miskolc, , 3529

Veszprem Megyei Tudogyogyintezet, Farkasgyepű, Hungary

Status

Recruiting

Address

Veszprem Megyei Tudogyogyintezet

Farkasgyepű, , 8582

Semmelweis Egyetem, Budapest, Hungary

Status

Recruiting

Address

Semmelweis Egyetem

Budapest, , 1125

Solingen, Germany

Status

Recruiting

Address

Krankenhaus Bethanien - Klinik für Pneumologie und Allergologie

Solingen, , 42699

Lungenfachklinik Immenhausen, Immenhausen, Germany

Status

Recruiting

Address

Lungenfachklinik Immenhausen

Immenhausen, , 34376

Pneumologisches Forschungsinstitut, Großhansdorf, Germany

Status

Recruiting

Address

Pneumologisches Forschungsinstitut

Großhansdorf, , 22927

Praxis Dr. med. Claus Keller, Frankfurt, Germany

Status

Recruiting

Address

Praxis Dr. med. Claus Keller

Frankfurt, , 60389

Ruhrlandklinik, Essen, Germany

Status

Recruiting

Address

Ruhrlandklinik

Essen, , 45239

CHU de Reims, Reims, France

Status

Recruiting

Address

CHU de Reims

Reims, , 51092

Groupe Hospitalier Bichat Claude Bernard, Paris, France

Status

Recruiting

Address

Groupe Hospitalier Bichat Claude Bernard

Paris, , 75018

Montpellier, France

Status

Recruiting

Address

Centre Hospitalier Regional Universitaire Montpellier

Montpellier, , 34295

Hôpital Nord AP-HM, Marseille, France

Status

Recruiting

Address

Hôpital Nord AP-HM

Marseille, , 13915

Vancouver General Hospital, Vancouver, Canada

Status

Recruiting

Address

Vancouver General Hospital

Vancouver, , V5Z 1M9

Québec, Canada

Status

Recruiting

Address

Institut Universitaire de Cardiologie et de Pneumologie

Québec, , G1V 4G5

Windsor, Ontario, Canada

Status

Recruiting

Address

Dr Anil Dhar Professional Medicine Corporation

Windsor, Ontario, N8W1L9

Mar Del Plata, Argentina

Status

Recruiting

Address

Instituto de Investigaciones Clínicas Mar Del Plata

Mar Del Plata, , B7600FZN

Centro Médico Dra de Salvo, Buenos Aires, Argentina

Status

Recruiting

Address

Centro Médico Dra de Salvo

Buenos Aires, , C1426ABP

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