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

  • STATUS
    Recruiting
  • End date
    Dec 5, 2021
  • participants needed
    750
  • sponsor
    Galapagos NV
Updated on 5 November 2020
Investigator
Galapagos Medical Information
Primary Contact
Concord Repatriation General Hospital (3.5 mi away) Contact
+169 other location
ct scan
carbon monoxide
pulmonary function test
nintedanib
emphysema
6-minute walk test
walk tests
pirfenidone
lung biopsy
glpg1690

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).

Details
Treatment Placebo, GLPG1690
Clinical Study IdentifierNCT03711162
SponsorGalapagos NV
Last Modified on5 November 2020

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Eligibility

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Inclusion Criteria

Is your age greater than or equal to 40 yrs?
Gender: Male or Female
Do you have any of these conditions: Pulmonary Fibrosis or Idiopathic Pulmonary Fibrosis?
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
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