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

Galapagos

Status and phase: Completed; Phase 2

Conditions: Idiopathic Pulmonary Fibrosis

Treatments: Drug: GLPG1690 600 mg QD; Drug: Placebo QD

Study type: Interventional

Funder types: Industry

Identifiers

NCT02738801

GLPG1690-CL-202

2015-004157-41 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 23 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

23 participants in 2 patient groups, including a placebo group

GLPG1690 600 mg once daily (QD)

Experimental group

Treatment:

Drug: GLPG1690 600 mg QD

Placebo QD

Placebo Comparator group

Treatment:

Drug: Placebo QD