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
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Intervention: GLPG1690; Placebo
Intervention description: GLPG1690, film-coated tablets for oral use.; Matching placebo, film-coated tablets for oral use.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 525.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

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

Eligibility 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).

          -  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.