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 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).

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:
NCT03711162

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 Australia, Czechia, Denmark, Germany, Greece, Spain, Taiwan, 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.

University of Wisconsin, Madison, Wisconsin

Status

Recruiting

Address

University of Wisconsin

Madison, Wisconsin, 53792

McKinney, Texas

Status

Recruiting

Address

Metroplex Pulmonary and Sleep Medicine Center

McKinney, Texas, 75069

Vanderbilt University Medical Center, Nashville, Tennessee

Status

Recruiting

Address

Vanderbilt University Medical Center

Nashville, Tennessee, 37232

Rhode Island Hospital, Providence, Rhode Island

Status

Recruiting

Address

Rhode Island Hospital

Providence, Rhode Island, 02903

The Oregon Clinic, Portland, Oregon

Status

Recruiting

Address

The Oregon Clinic

Portland, Oregon, 97220

PulmonIx LLC, Greensboro, North Carolina

Status

Recruiting

Address

PulmonIx LLC

Greensboro, North Carolina, 27403

Creighton University, Omaha, Nebraska

Status

Recruiting

Address

Creighton University

Omaha, Nebraska, 68131

Minnesota Lung Center, Minneapolis, Minnesota

Status

Recruiting

Address

Minnesota Lung Center

Minneapolis, Minnesota, 55407

Caritas St. Elizabeth's Medical Center, Boston, Massachusetts

Status

Recruiting

Address

Caritas St. Elizabeth's Medical Center

Boston, Massachusetts, 02135

Tulane Medical Center, New Orleans, Louisiana

Status

Recruiting

Address

Tulane Medical Center

New Orleans, Louisiana, 70112

Council Bluffs, Iowa

Status

Recruiting

Address

Pulmonary and Infections Disease Associates

Council Bluffs, Iowa, 51503

Stanford University Medical Center, Chicago, Illinois

Status

Recruiting

Address

Stanford University Medical Center

Chicago, Illinois, 60611

PAB Clinical Research - ClinEdge - PPDS, Brandon, Florida

Status

Recruiting

Address

PAB Clinical Research - ClinEdge - PPDS

Brandon, Florida, 33511

National Jewish Health, Denver, Colorado

Status

Recruiting

Address

National Jewish Health

Denver, Colorado, 80206

Pulmonary Associates, Phoenix, Arizona

Status

Recruiting

Address

Pulmonary Associates

Phoenix, Arizona, 85006

International Sites

National Taiwan University Hospital, Taipei, Taiwan

Status

Recruiting

Address

National Taiwan University Hospital

Taipei, , 10002

Valencia, Spain

Status

Recruiting

Address

Consorcio Hospital General Universitario de Valencia

Valencia, , 46014

Santander, Spain

Status

Recruiting

Address

Hospital Universitario Marques de Valdecilla

Santander, , 39008

Clinica Universidad Navarra, Pamplona, Spain

Status

Recruiting

Address

Clinica Universidad Navarra

Pamplona, , 31008

Hospital Clinico San Carlos, Madrid, Spain

Status

Recruiting

Address

Hospital Clinico San Carlos

Madrid, , 28040

Hospital Universitario de La Princesa, Madrid, Spain

Status

Recruiting

Address

Hospital Universitario de La Princesa

Madrid, , 28006

Barcelona, Spain

Status

Recruiting

Address

Hospital Universitario de Bellvitge, Hospitalet De Llobregat

Barcelona, , 08097

Hospital Clinical de Barcelona, Barcelona, Spain

Status

Recruiting

Address

Hospital Clinical de Barcelona

Barcelona, , 03036

CHUVI - H.U. Alvaro Cunquerio, Vigo, Pontevedra, Spain

Status

Recruiting

Address

CHUVI - H.U. Alvaro Cunquerio

Vigo, Pontevedra, 36312

Thessaloníki, Greece

Status

Recruiting

Address

Georgios Papanikolaou General Hospital of Thessaloniki

Thessaloníki, , 57010

University General Hospital of Heraklion, Iraklio, Greece

Status

Recruiting

Address

University General Hospital of Heraklion

Iraklio, , 71110

Sotiria Chest Hospital of Athens, Athens, Greece

Status

Recruiting

Address

Sotiria Chest Hospital of Athens

Athens, , 11527

Klinikum Rosenheim, Rosenheim, Germany

Status

Recruiting

Address

Klinikum Rosenheim

Rosenheim, , 83022

Evangelische Lungenklinik, Berlin, Germany

Status

Recruiting

Address

Evangelische Lungenklinik

Berlin, , 13125

Odense Universitetshospital, Odense, Denmark

Status

Recruiting

Address

Odense Universitetshospital

Odense, , 5000

Gentofte Hospital, Hellerup, Denmark

Status

Recruiting

Address

Gentofte Hospital

Hellerup, , 2900

Aarhus Universitetshospital, Aarhus, Denmark

Status

Recruiting

Address

Aarhus Universitetshospital

Aarhus, , 8200

Nemocnice Na Bulovce, Praha, Czechia

Status

Recruiting

Address

Nemocnice Na Bulovce

Praha, , 180 81

Thomayerova nemocnice, Praha, Czechia

Status

Recruiting

Address

Thomayerova nemocnice

Praha, , 14059

Respiratory Clinical Trials Pty Ltd, Kent Town, South Australia, Australia

Status

Recruiting

Address

Respiratory Clinical Trials Pty Ltd

Kent Town, South Australia, 5067

Lung Research Qld, Chermside, Queensland, Australia

Status

Recruiting

Address

Lung Research Qld

Chermside, Queensland, 4060

Concord Repatriation General Hospital, Concord, New South Wales, Australia

Status

Recruiting

Address

Concord Repatriation General Hospital

Concord, New South Wales, 2139

Terms of Service

The PFF does not promote or represent that any investigational new drugs mentioned are safe or effective. The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. For a full description of terms please refer to our Terms, Conditions & Privacy.

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