Study to Assess Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of GLPG1690 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)

• Status: Completed
• Trial end date: 2017-05-02
• Target enrollment: 0
• Participant gender: All

Summary

A multicenter randomized, double-blind, parallel group, placebo-controlled, exploratory phase IIa study in subjects with Idiopathic Pulmonary Fibrosis (IPF) to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of GLPG1690. Male and female subjects aged 40 years or older will be screened to determine eligibility. The screening period will be up to 4 weeks. At baseline, eligible subjects will be randomized in a 3:1 ratio to GLPG1690 or matching placebo administered for 12 weeks. The subjects will visit the study center at screening, baseline, Weeks 1, 2, 4, 8 and 12 and for a follow-up visit 2 weeks after the last administration of study drug. Planned assessments: Adverse event reporting, clinical laboratory tests, vital signs, physical examination, 12-Lead-ECG, PK blood sampling, biomarker blood/bronchoalveolar lavage fluid (BALF), Spirometry, St George's respiratory questionnaire, high-resolution computed tomography (HRCT).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Galapagos NV

Criteria

Inclusion Criteria:

1. Subjects able and willing to sign the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved Informed Consent Form (ICF)

2. Male or female subjects of non-child-bearing potential aged ≥ 40 years

3. Subjects with a chest HRCT performed within 12 months prior to screening

4. Subjects with IPF diagnosed by a multidisciplinary team

5. Subjects with: a. forced vital capacity (FVC) ≥50% predicted of normal AND b. Diffusing capacity for the lungs for carbon monoxide (DLCO) ≥ 30% predicted of normal corrected for hemoglobin

6. Subjects with a forced expiratory volume in 1 second (FEV1)/FVC (Tiffeneau-Pinelli index) ratio ≥ 0.70 (based on pre-bronchodilator spirometry

7. Subjects on stable supportive care

8. Subjects in stable condition

Exclusion Criteria:

1. Subjects with know hypersensitivity to any of the study drug ingredients

2. Subjects with a history of or current immunosuppressive condition

3. Subjects with a history of malignancy within the past 5 years

4. Subjects with clinically significant abnormalities on ECG

5. Subjects with acute IPF exacerbation within 6 weeks prior to screening

6. Subjects with a lower respiratory tract infection requiring antibiotics with 4 weeks prior to screening

7. Smoking within 3 months pre-screening

8. Interstitial lung disease

9. History of lung volume reduction surgery or lung transplant

10. Unstable cardiac or pulmonary disease other than IPF within 6 months prior to screening

11. Subjects with abnormal liver function

12. Subjects with abnormal renal function