PHASE 3, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, PLACEBO-CONTROLLED MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF TWO DOSES OF GLPG1690 IN ADDITION TO LOCAL STANDARD OF CARE FOR MINIMUM 52 WEEKS IN SUBJECTS WITH IDIOPATHIC PULMONARY FIBROSIS.

Galapagos N.V,0 sites21 target enrollmentMay 17, 2019

Conditions-J841 Other interstitial pulmonary diseases with fibrosis Other interstitial pulmonary diseases with fibrosis J841

Overview

Phase: 未知
Intervention: Not specified
Conditions: -J841 Other interstitial pulmonary diseases with fibrosis
Sponsor: Galapagos N.V,
Enrollment: 21
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

May 17, 2019

End Date

April 8, 2021

Last Updated

2 years ago

Study Type

Interventional

Investigators

Sponsor

Galapagos N.V,

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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.