A CLINICAL STUDY TO TEST HOW EFFECTIVE AND SAFE GLPG1690 (G451990) IS FOR SUBJECTS WITH IDIOPATHIC PULMONARY FIBROSIS (IPF) WHEN USED TOGETHER WITH STANDARD MEDICAL TREATMENT.
- Conditions
- J841-J841 Other interstitial pulmonary diseases with fibrosisOther interstitial pulmonary diseases with fibrosis
- Registration Number
- PER-001-19
- Lead Sponsor
- Galapagos N.V,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 21
1.Able and willing to comply with the protocol requirements and signed the informed consent form (ICF) as approved by the Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to any screening evaluations.
2. Subject must be able and willing to comply with restrictions on prior and concomitant medication.
3. Male or female subject aged ≥40 years on the day of signing the ICF.
4. A diagnosis of IPF within 5 years prior to the screening visit, as per applicable ATS/ERS/JRS/ALAT guidelines.
5. 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 <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.
6. Subjects receiving local standard of care for the treatment of IPF, defined as either pirfenidone or nintedanib, or neither pirfenidone nor nintedanib (for any reason).
7. The extent of fibrotic changes is greater than the extent of emphysema on the most recent HRCT scan (investigator-determined).
8. 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. • DLCO corrected for Hb ≥30% predicted of normal.
9. In a stable condition and suitable for study participation based on the results of a medical history, physical examination, vital signs, 12-lead ECG, and laboratory evaluation.
10. Estimated minimum life expectancy of at least 30 months for non-IPF related disease in the opinion of the investigator.
11. Male subjects and female subjects of childbearing potential agree to use highly effective contraception/preventive exposure measures from the time of first dose of 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.
12. Able to walk at least 150 meters during the 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 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 ≤4 L O2/minute.
13. Able to read and complete the EQ-5D, SGRQ, LCQ, K-BILD questionnaire, and VAS by themselves.
14. Able to understand the importance of adherence, and willing to comply to study treatment, study procedures and requirements as per study protocol, including the concomitant medication restrictions.
1. Investigator or other study staff or relative thereof who is directly involved in the conduct of the study.
2. Any clinical condition or other condition or circumstance that, in the opinion of the investigator, may make a subject unsuitable for inclusion or unlikely or unable to complete the study or comply with study procedures and requirements.
3. Previous participation in a clinical study with GLPG1690 (active or placebo).
4. Known hypersensitivity to any of the IMP ingredients or a history of a significant allergic reaction to any drug as determined by the investigator (e.g. anaphylaxis requiring hospitalization).
5. History of or a current immunosuppressive condition (e.g. human immunodeficiency virus [HIV] infection, congenital, acquired, medication-induced).
6. Positive serology for hepatitis B (antigen) or C (antibody), or any history of hepatitis from any cause with the exception of hepatitis A.
7. 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).
8. Clinically significant abnormalities detected on ECG of either rhythm or conduction, a QTcF >450 ms, or a known long QT syndrome.
9. Currently taking medication known to be a substrate mainly metabolized by CYP2C8.
10. Currently taking medication known to be strong inducers of CYP3A4, and also including St-John’s Wort.
11. Currently taking medication known to be strong inhibitors of CYP3A4.
12. Currently taking medication known to be potent inducers of P-gp.
13. Currently taking medication known to be potent inhibitors of P-gp.
14. Acute IPF exacerbation within 6 months prior to screening and/or during the screening period.
15. Lower respiratory tract infection requiring antibiotics within 4 weeks prior to screening and/or during the screening period.
16. 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).
17. History of lung volume reduction surgery or lung transplant. Note: being on a transplant list is allowed.
18. Diagnosis of severe pulmonary hypertension (investigator-determined).
19. 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).
20. Underwent major surgery within 3 months prior to screening or have major surgery planned during the study period.
21. A history of being admitted to an institution under an administrative or court order, if applicable by local legislation.
22. Abnormal LFT at screening, defined as AST, and/or ALT, and/or total bilirubin ≥1.5xULN, and/or GGT ≥3xULN. Retesting is allowed once.
23. Abnormal renal function defined as estimated creatinine clearance, calculated according to Cockcroft-Gault calculation (CCr) <30 mL/min. Retesting is allowed once.
24. Hb level <10 g/dL. Retesting is allowed once.
25. Participation in a drug, device, or biological investigational research study, concurrently with the current study, or within 5 half-lives of the age
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:The FVC will be measured as part of the spirometry assessment.<br>Measure:Rate of decline of forced vital capacity (FVC) in mL<br>Timepoints:From baseline through week 52<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:The FVC will be measured as part of the spirometry assessment. A time to mortality event analysis will be conducted.<br>Measure:Disease progression<br>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<br><br>Timepoints:At week 52<br>;<br>Outcome name:A time to first hospitalization analysis will be conducted.<br>Measure:Time to first respiratory-related hospitalization until the end of the study<br>Timepoints:From screening through study completion, a minimum of 52 weeks.<br>;<br>Outcome name:St. George Respiratory Questionnaire (SGRQ)<br>Measure:Change from baseline in the St. George Respiratory Questionnaire (SGRQ) total score<br>Timepoints:At week 52<br>