Idiopatic pulmonary fibrosis MedDRA version: 20.0 Level: SOC Classification code 10038738 Term: Respiratory, thoracic and mediastinal disorders System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Sponsors
Galapagos NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female subject aged =40 years on the day of signing the ICF. - A diagnosis of IPF within 5 years prior to the screening visit, as per applicable ATS/ERS/JRS/ALAT guideline at the time of diagnosis. - Chest 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 LB available), or based on both HRCT and LB (with application of the different criteria in either situation). If an evaluable HRCT =65 years) yes F.1.3.1 Number of subjects for this age range 375
Exclusion criteria
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 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 5xULN and increased susceptibility to elevated LFT; moderate to severe hepatic impairment (Child-Pugh B or C) and/or abnormal LFT at screening, defined as AST, and/or ALT, and/or total bilirubin =1.5xULN, and/or GGT =3xULN. Retesting is allowed once for abnormal LFT. - Abnormal renal function defined as estimated creatinine clearance, calculated according to Cockcroft-Gault calculation (CCr) 10 mg/day or equivalent. - Clinical laboratory test suggestive of cholestasis with total serum bile acid levels >3xULN.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of two doses of GLPG1690 in addition to local standard of care compared to placebo in subjects with IPF as evaluated by the rate of decline of FVC over a period of 52 weeks;Secondary Objective: To evaluate the impact of two doses of GLPG1690 in addition to local standard of care compared to placebo in subjects with IPF on: - Disease progression defined as deterioration of FVC or all-cause mortality at 52 weeks - Respiratory-related hospitalization until the end of the study - Changes in quality of life (measured by St. George’s Respiratory Questionnaire [SGRQ] total score) at 52 weeks;Primary end point(s): Rate of decline of FVC (in mL) over a period of 52 weeks;Timepoint(s) of evaluation of this end point: At week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - 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 at 52 weeks - Time to first respiratory-related hospitalization until the end of the study - Change from baseline in the SGRQ total score at 52 weeks;Timepoint(s) of evaluation of this end point: Various timepoints during the trial as specified in the protocol | — |
Countries
Australia, Belgium, Brazil, Chile, Czech Republic, Denmark, Finland, Germany, Greece, Peru, Spain, Taiwan, Turkey, United Kingdom, United States
Contacts
Public ContactClinical Trial Information Desk
Galapagos NV
Outcome results
None listed