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

NCT ID: NCT02738801

Last Updated: 2020-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2017-05-02

Brief 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).

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

Idiopathic Pulmonary Fibrosis; GLPG1690; Autotaxin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

GLPG1690 600 mg once daily (QD)

Group Type: EXPERIMENTAL

GLPG1690 600 mg QD

Intervention Type: DRUG

GLPG1690 capsules, administered at a dose of 600 mg, orally QD

Placebo QD

Group Type: PLACEBO_COMPARATOR

Placebo QD

Intervention Type: DRUG

Matching placebo capsules, administered orally QD

Interventions

GLPG1690 600 mg QD

GLPG1690 capsules, administered at a dose of 600 mg, orally QD

Intervention Type: DRUG

Placebo QD

Matching placebo capsules, administered orally QD

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Galapagos NV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ann Fieuw, MD

Role: STUDY_DIRECTOR

Galapagos NV

Locations

Municipal Clinical Hospital # 6

Dnipropetrovsk, , Ukraine

Kharkov City Clinical Hospital # 13

Kharkiv, , Ukraine

F.G. Yanovskyy Institute of Phthisiatry and Pulmonology 1

Kiev, , Ukraine

F.G. Yanovskyy Institute of Phthisiatry and Pulmonology 2

Kiev, , Ukraine

Oesa Regional Clinical Hospital

Odesa, , Ukraine

Poltava Regional Clinical Antituberculosis Dispancery

Poltava, , Ukraine

Royal Brompton Hospital

London, , United Kingdom

The Medicines Evaluation Unit

Manchester, , United Kingdom

Countries

Italy; Ukraine; United Kingdom

References

Maher TM, van der Aar EM, Van de Steen O, Allamassey L, Desrivot J, Dupont S, Fagard L, Ford P, Fieuw A, Wuyts W. Safety, tolerability, pharmacokinetics, and pharmacodynamics of GLPG1690, a novel autotaxin inhibitor, to treat idiopathic pulmonary fibrosis (FLORA): a phase 2a randomised placebo-controlled trial. Lancet Respir Med. 2018 Aug;6(8):627-635. doi: 10.1016/S2213-2600(18)30181-4. Epub 2018 May 20.

Reference Type: DERIVED

PMID: 29792287 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2015-004157-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GLPG1690-CL-202

Identifier Type: -

Identifier Source: org_study_id