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

Primary Purpose

Idiopathic Pulmonary Fibrosis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
GLPG1690 600 mg QD
Placebo QD
Sponsored by
Galapagos NV
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis focused on measuring Idiopathic Pulmonary Fibrosis, GLPG1690, Autotaxin

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Municipal Clinical Hospital # 6
  • Kharkov City Clinical Hospital # 13
  • F.G. Yanovskyy Institute of Phthisiatry and Pulmonology 1
  • F.G. Yanovskyy Institute of Phthisiatry and Pulmonology 2
  • Oesa Regional Clinical Hospital
  • Poltava Regional Clinical Antituberculosis Dispancery
  • Royal Brompton Hospital
  • The Medicines Evaluation Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

GLPG1690 600 mg once daily (QD)

Placebo QD

Arm Description

Outcomes

Primary Outcome Measures

Number of Patients With Treatment-Emergent Adverse Events (AEs)
Mean Maximum Observed Plasma Concentration (Cmax; Micrograms Per Milliliter [µg/mL]) of GLPG1690
Median Time to Occurrence of GLPG1690 Cmax (Tmax; Hours [h])
Mean Area Under the Plasma Concentration-Time Curve (AUC[t]; µg.h/mL) of GLPG1690
Mean GLPG1690 Plasma Concentration Observed at Predose (Ctrough; µg/mL)
Mean Peak Area Ratio of Lysophosphatidic Acid (LPA) C18:2 Species in Blood
LPA species C18:2 concentrations were determined in blood using a validated liquid chromatography tandem mass spectometry (LC/MS-MS) method. The baseline reference timepoint was Day -1 (mean of the pre-dosing duplicates).
Mean Peak Area Ratio of LPA C18:2 Species in Bronchoalveolar Lavage Fluid (BALF)
LPA species C18:2 concentrations were determined in BALF using a validated LC/MS-MS method. The baseline reference timepoint was Day -1 (mean of the pre-dosing duplicates).

Secondary Outcome Measures

Full Information

First Posted
April 11, 2016
Last Updated
October 16, 2020
Sponsor
Galapagos NV
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1. Study Identification

Unique Protocol Identification Number
NCT02738801
Brief Title
Study to Assess Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of GLPG1690 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
Official Title
Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Multicenter, Exploratory Phase IIa Study to Assess Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of GLPG1690 Administered for 12 Weeks in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
May 2, 2017 (Actual)
Study Completion Date
May 2, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galapagos NV

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis
Keywords
Idiopathic Pulmonary Fibrosis, GLPG1690, Autotaxin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GLPG1690 600 mg once daily (QD)
Arm Type
Experimental
Arm Title
Placebo QD
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
GLPG1690 600 mg QD
Intervention Description
GLPG1690 capsules, administered at a dose of 600 mg, orally QD
Intervention Type
Drug
Intervention Name(s)
Placebo QD
Intervention Description
Matching placebo capsules, administered orally QD
Primary Outcome Measure Information:
Title
Number of Patients With Treatment-Emergent Adverse Events (AEs)
Time Frame
From screening up to Day 98
Title
Mean Maximum Observed Plasma Concentration (Cmax; Micrograms Per Milliliter [µg/mL]) of GLPG1690
Time Frame
Baseline, predose on Days 7, 14, 28, 56, 84, and 98 (or at early discontinuation), and at 1.5, 4, and 6 hours postdose on Day 28
Title
Median Time to Occurrence of GLPG1690 Cmax (Tmax; Hours [h])
Time Frame
Baseline, predose on Days 7, 14, 28, 56, 84, and 98 (or at early discontinuation), and at 1.5, 4, and 6 hours postdose on Day 28
Title
Mean Area Under the Plasma Concentration-Time Curve (AUC[t]; µg.h/mL) of GLPG1690
Time Frame
Baseline, predose on Days 7, 14, 28, 56, 84, and 98 (or at early discontinuation), and at 1.5, 4, and 6 hours postdose on Day 28
Title
Mean GLPG1690 Plasma Concentration Observed at Predose (Ctrough; µg/mL)
Time Frame
Baseline, predose on Days 7, 14, 28, 56, 84, and 98 (or at early discontinuation), and at 1.5, 4, and 6 hours postdose on Day 28
Title
Mean Peak Area Ratio of Lysophosphatidic Acid (LPA) C18:2 Species in Blood
Description
LPA species C18:2 concentrations were determined in blood using a validated liquid chromatography tandem mass spectometry (LC/MS-MS) method. The baseline reference timepoint was Day -1 (mean of the pre-dosing duplicates).
Time Frame
Baseline (Day -1), predose and 1.5 and 6 hours postdose on Day 28, predose on Day 84, and Day 98 (or early discontinuation)
Title
Mean Peak Area Ratio of LPA C18:2 Species in Bronchoalveolar Lavage Fluid (BALF)
Description
LPA species C18:2 concentrations were determined in BALF using a validated LC/MS-MS method. The baseline reference timepoint was Day -1 (mean of the pre-dosing duplicates).
Time Frame
Baseline (Day -1) and Day 84

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects able and willing to sign the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved Informed Consent Form (ICF) Male or female subjects of non-child-bearing potential aged ≥ 40 years Subjects with a chest HRCT performed within 12 months prior to screening Subjects with IPF diagnosed by a multidisciplinary team 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 Subjects with a forced expiratory volume in 1 second (FEV1)/FVC (Tiffeneau-Pinelli index) ratio ≥ 0.70 (based on pre-bronchodilator spirometry Subjects on stable supportive care Subjects in stable condition Exclusion Criteria: Subjects with know hypersensitivity to any of the study drug ingredients Subjects with a history of or current immunosuppressive condition Subjects with a history of malignancy within the past 5 years Subjects with clinically significant abnormalities on ECG Subjects with acute IPF exacerbation within 6 weeks prior to screening Subjects with a lower respiratory tract infection requiring antibiotics with 4 weeks prior to screening Smoking within 3 months pre-screening Interstitial lung disease History of lung volume reduction surgery or lung transplant Unstable cardiac or pulmonary disease other than IPF within 6 months prior to screening Subjects with abnormal liver function Subjects with abnormal renal function
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann Fieuw, MD
Organizational Affiliation
Galapagos NV
Official's Role
Study Director
Facility Information:
Facility Name
Municipal Clinical Hospital # 6
City
Dnipropetrovsk
Country
Ukraine
Facility Name
Kharkov City Clinical Hospital # 13
City
Kharkov
Country
Ukraine
Facility Name
F.G. Yanovskyy Institute of Phthisiatry and Pulmonology 1
City
Kiev
Country
Ukraine
Facility Name
F.G. Yanovskyy Institute of Phthisiatry and Pulmonology 2
City
Kiev
Country
Ukraine
Facility Name
Oesa Regional Clinical Hospital
City
Odesa
Country
Ukraine
Facility Name
Poltava Regional Clinical Antituberculosis Dispancery
City
Poltava
Country
Ukraine
Facility Name
Royal Brompton Hospital
City
London
Country
United Kingdom
Facility Name
The Medicines Evaluation Unit
City
Manchester
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29792287
Citation
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.
Results Reference
derived

Learn more about this trial

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

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