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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-004157-41 | EudraCT Number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLPG1690 600 mg once daily (QD) | Experimental |
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| Placebo QD | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLPG1690 600 mg QD | Drug | GLPG1690 capsules, administered at a dose of 600 mg, orally QD |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Treatment-Emergent Adverse Events (AEs) | From screening up to Day 98 | |
| Mean Maximum Observed Plasma Concentration (Cmax; Micrograms Per Milliliter [µg/mL]) of GLPG1690 | 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 | |
| Median Time to Occurrence of GLPG1690 Cmax (Tmax; Hours [h]) | 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 | |
| Mean Area Under the Plasma Concentration-Time Curve (AUC[t]; µg.h/mL) of GLPG1690 | 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 | |
| Mean GLPG1690 Plasma Concentration Observed at Predose (Ctrough; µg/mL) | 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 | |
| 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). | Baseline (Day -1), predose and 1.5 and 6 hours postdose on Day 28, predose on Day 84, and Day 98 (or early discontinuation) |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ann Fieuw, MD | Lakefront Biotherapeutics NV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Municipal Clinical Hospital # 6 | Dnipropetrovsk | Ukraine | ||||
| Kharkov City Clinical Hospital # 13 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29792287 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Once Daily (QD) | Participants received matching oral capsules QD for 12 weeks. |
| FG001 | GLPG1690 600 mg QD | Participants received 600 mg GLPG1690, administered as oral capsules QD for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 16, 2015 | Oct 16, 2020 |
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| Placebo QD | Drug | Matching placebo capsules, administered orally QD |
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| Baseline (Day -1) and Day 84 |
| 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 |
| COMPLETED |
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| NOT COMPLETED |
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Safety population: all randomized participants who received at least one dose of GLPG1690.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo QD | Participants received matching oral capsules QD for 12 weeks. |
| BG001 | GLPG1690 600 mg QD | Participants received 600 mg GLPG1690, administered as oral capsules QD for 12 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With Treatment-Emergent Adverse Events (AEs) | Safety Population: all randomized participants who received at least one dose of GLPG1690. | Posted | Count of Participants | Participants | From screening up to Day 98 |
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| Primary | Mean Maximum Observed Plasma Concentration (Cmax; Micrograms Per Milliliter [µg/mL]) of GLPG1690 | Pharmacokinetic (PK) Analysis Set: all randomized participants who received at least one dose of GLPG1690 and for whom evaluable PK data were available. Excludes 1 patient who withdrew because of an AE prior to Week 1 (and had only PK concentrations for baseline and early discontinuation) and 1 patient with only a single predose sample at Week 4 | Posted | Mean | Standard Deviation | µg/mL | 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 |
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| Primary | Median Time to Occurrence of GLPG1690 Cmax (Tmax; Hours [h]) | PK Analysis Population; excludes 1 patient who withdrew because of an AE prior to Week 1 (and had only PK concentrations for baseline and early discontinuation) and 1 patient with only a single predose sample at Week 4. | Posted | Median | Full Range | hours | 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 |
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| Primary | Mean Area Under the Plasma Concentration-Time Curve (AUC[t]; µg.h/mL) of GLPG1690 | PK Analysis Population; excludes 1 patient who withdrew because of an AE prior to Week 1 (and had only PK concentrations for baseline and early discontinuation) and 1 patient with only a single predose sample at Week 4. | Posted | Mean | Standard Deviation | µg.h/mL | 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 |
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| Primary | Mean GLPG1690 Plasma Concentration Observed at Predose (Ctrough; µg/mL) | PK Analysis Population; excludes 1 patient who withdrew because of an AE prior to Week 1 (and had only PK concentrations for baseline and early discontinuation) and 1 patient with only a single predose sample at Week 4. | Posted | Mean | Standard Deviation | µg/mL | 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 |
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| Primary | 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). | Pharmacodynamic (PD) Population: all randomized participants who received at least one dose of GLPG1690 and had at least one postbaseline assessment with PD data. Only patients with assessments at both baseline and the pre-specified visit(s) were included in the analysis. | Posted | Mean | Standard Error | peak area ratio | Baseline (Day -1), predose and 1.5 and 6 hours postdose on Day 28, predose on Day 84, and Day 98 (or early discontinuation) |
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| Primary | 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). | PD Population; only patients with assessments at both baseline and the pre-specified visit were included in the analysis. | Posted | Mean | Standard Error | peak area ratio | Baseline (Day -1) and Day 84 |
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From Screening to final follow-up visit (Day 98)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo QD | Participants received matching oral capsules QD for 12 weeks. | 0 | 6 | 2 | 6 | 4 | 6 |
| EG001 | GLPG1690 600 mg QD | Participants received 600 mg GLPG1690, administered as oral capsules QD for 12 weeks. | 0 | 17 | 1 | 17 | 11 | 17 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrioventricular block second degree | Cardiac disorders | MedDRA | Systematic Assessment |
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| Lower respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Cholangiocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lower respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Infected cyst | Infections and infestations | MedDRA | Systematic Assessment |
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| Pyelonephritis acute | Infections and infestations | MedDRA | Systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Orchitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Pneumothorax spontaneous | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Fatigue | General disorders | MedDRA | Systematic Assessment |
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| Peripheral swelling | General disorders | MedDRA | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA | Systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | MedDRA | Systematic Assessment |
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| Electrocardiogram PR prolongation | Investigations | MedDRA | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
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| Loss of consciousness | Nervous system disorders | MedDRA | Systematic Assessment |
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| Bradycardia | Cardiac disorders | MedDRA | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Orthostatic hypotension | Vascular disorders | MedDRA | Systematic Assessment |
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None reported.
The investigator must agree that before publishing or communicating any results of the trial, the sponsor has at least 60 days for full review of the information prior to submission.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Evelyn Fox | Galapagos NV | 003215342900 | 3215342900 | evelyn.fox@glpg.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 16, 2017 | Oct 16, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000621178 | GLPG1690 |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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