Principal Investigator: Mary  Scholand
Keywords: IPF , GLPG 1690 , GLPG1690 , Galapagos , Interstitial Lung Disease , idiopathic pulmonary fibrosis Department: Pulmonary
IRB Number: 00117684 Co Investigator: Cheryl  Pirozzi
Specialty: Pulmonary, Pulmonary, Pulmonary, Pulmonary
Sub Specialties: Pulmonary Fibrosis, Pulmonary Function, General Pulmonary, Pulmonary
Recruitment Status: Completed

Contact Information

Cassie Larsen
cassie.larsen@hsc.utah.edu
8015815811

Simple Summary

**

Inclusion Criteria

Subjects who meet all of the following criteria are eligible for this clinical study:

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 as described in Section 4.5.3.2.

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) (see Appendix1). If an evaluable HRCT <12months 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 pirfenidonenor nintedanib(for any reason).

7. The extent of fibrotic changes is greater than the extent of emphysema on the most recent HRCTscan (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(see Appendix2).

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. Stable condition is based on the clinical judgment of the investigator; co-morbidities should be treated according to the local applicable guidelines. Concomitant medication for co-morbidities should have been stable from 4 weeks prior to screening and during the screening period (stable defined as no change of dose or regimen).

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 ofIMP.

12.Able to walk at least 150 meters during the 6MWT at screening Visit 1; without having a contraindication to perform the 6MWT (see Appendix10) 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 ≤4LO2/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 (described in Section 4.5.3.2). 

Exclusion Criteria

Subjects meeting one or more of the following criteria cannot be selected for this clinical study:

1. Investigator or other study staff or relative thereof who is directly involved in the conduct of the study.

2. Any condition or circumstance that, in the opinion of the investigator, may make a subject 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. A current immunosuppressive condition (e.g. human immunodeficiency virus [HIV] infection, congenital, acquired, medication-induced). Subjects treated with stable doses of immunosuppressive medications for reasons other than IPF are allowed to participate in the study on a case-by-case basis based on discussion with the sponsor’s medical monitor.

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. 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.

9. Currently taking medication known to be a substrate mainly metabolized by CYP2C8 (see Appendix 3).

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 treatment 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. Any other clinical condition or circumstance that, in the opinion of the investigator, may make the subject unsuitable for inclusion or unable to complete the study or comply with study procedures and requirements.

22. History of nintedanib-related increase in ALT and/or AST of >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.

23. Abnormal renal function defined as estimated creatinine clearance, calculated according to Cockcroft-Gault calculation (CCr)<30mL/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 agent (or within 8 weeks when 

25. Concurrent participation in another interventional drug, device, or biological
investigational research study, or use of an investigational agent within 5 halflives
of the agent (or within 8 weeks when halflife
is unknown, or within 6 months if
the investigational agent is an antibody) prior to screening is not allowed.

26. 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.

27. Current alcohol or substance abuse in the opinion of the investigator.
28. Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
treatment or within 30 days after the last dose of IMP.
29. Clinical laboratory test suggestive of cholestasis with total serum bile acid levels
>3xULN.

A current immunosuppressive condition (e.g. human immunodeficiency virus
[HIV] infection, congenital, acquired, medication-induced). Subjects treated with
stable doses of immunosuppressive medications for reasons other than IPF are
allowed to participate in the study on a case-by-case basis based on discussion
with the sponsor’s medical monitor.

Participant Reimbursement

You will be paid $50.00 at each visit.The sponsor will also compensate you for travel costs.