Trial record 3 of 7 for:
GLPG2222
A Study to Evaluate Multiple Doses of GLPG2222 in Adult Subjects With Cystic Fibrosis
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| ClinicalTrials.gov Identifier: NCT03119649 |
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Recruitment Status :
Completed
First Posted : April 18, 2017
Results First Posted : November 16, 2018
Last Update Posted : November 16, 2018
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Sponsor:
Galapagos NV
Information provided by (Responsible Party):
Galapagos NV
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Brief Summary:
This is a Phase IIa, multi-center, randomized, double-blind, placebo-controlled, parallel-group study to evaluate 4 different doses of GLPG2222 administered for 4 weeks to adult subjects with a confirmed diagnosis of CF and homozygous for the F508del Cystic Fibrosis Transmembrane conductance Regulator (CFTR) mutation.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cystic Fibrosis | Drug: GLPG2222 50 mg Drug: GLPG2222 100 mg Drug: Placebo Drug: GLPG2222 200 mg Drug: GLPG2222 400 mg | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 59 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase IIa, Randomized, Double-blind, Placebo-controlled Study to Evaluate Multiple Doses of GLPG2222 in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation |
| Actual Study Start Date : | March 18, 2017 |
| Actual Primary Completion Date : | October 19, 2017 |
| Actual Study Completion Date : | October 19, 2017 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Cystic fibrosis
MedlinePlus related topics:
Cystic Fibrosis
| Arm | Intervention/treatment |
|---|---|
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Experimental: Cohort A: GLPG2222 50 mg once daily (QD)
Participants received a single GLPG2222 50 mg tablet and two matching placebo tablets orally, QD for 29 days.
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Drug: GLPG2222 50 mg
Oral tablet(s) containing GLPG2222 Drug: Placebo Matching oral tablet(s) containing placebo |
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Experimental: Cohort A: GLPG2222 100 mg QD
Participants received a single GLPG2222 100 mg tablet and two matching placebo tablets orally, QD for 29 days.
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Drug: GLPG2222 100 mg
Oral tablet(s) containing GLPG2222 Drug: Placebo Matching oral tablet(s) containing placebo |
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Experimental: Cohort B: GLPG2222 200 mg QD
Participants received two GLPG2222 100 mg tablets and one matching placebo tablet orally, QD for 29 days.
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Drug: Placebo
Matching oral tablet(s) containing placebo Drug: GLPG2222 200 mg Oral tablet(s) containing GLPG2222 |
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Experimental: Cohort B: GLPG2222 400 mg QD
Participants received two GLPG2222 150 mg tablets and one GLPG2222 100 mg tablet orally, QD for 29 days.
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Drug: Placebo
Matching oral tablet(s) containing placebo Drug: GLPG2222 400 mg Oral tablet(s) containing GLPG2222 |
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Placebo Comparator: Cohort A Placebo
Participants received three matching placebo tablets, orally, QD for 29 days.
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Drug: Placebo
Matching oral tablet(s) containing placebo |
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Placebo Comparator: Cohort B Placebo
Participants received three matching placebo tablets, orally, QD for 29 days.
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Drug: Placebo
Matching oral tablet(s) containing placebo |
Primary Outcome Measures :
- Number of Participants With Treatment-Emergent Adverse Events [ Time Frame: First administration (Day 1) through Follow-up (Day 43) ]Number of participants with any treatment-emergent adverse events (TEAEs) and serious or treatment-related TEAEs, as well as number of patients with TEAEs by worst intensity reported (mild, moderate, or severe).
Secondary Outcome Measures :
- Mean Change From Baseline in Sweat Chloride Concentration at Day 29 [ Time Frame: Prior to dosing on Days 1 and 29, or at early discontinuation ]Two sweat collections, one from each arm, were obtained. Mean sweat chloride concentration was determined from both arms and measured as millimoles per liter (mmol/L). Baseline was defined as the predose value on Day 1 (or the last non-missing predose measurement).
- Mean Change From Baseline in Percent (%) Predicted FEV1 (%FEV1) at Day 29 [ Time Frame: Predose and between 1 and 2 hours postdose on Days 1 and 29, or at early discontinuation ]Percent predicted FEV1 for age, gender, and height was determined from standardized spirometry assessments and estimated using the 2012 Global Lungs Initiative equation. Baseline was defined as the last non-missing predose assessment on Day 1.
- Mean Change From Baseline in the Respiratory Domain of the Cystic Fibrosis Questionnaire-Revised (CFQ-R) at Day 29 [ Time Frame: Prior to dosing on Days 1 and 29, or at early discontinuation ]The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. The respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), derived from Questions 40, 41, 42, 45, and 46 if at least 50% of the questions had non-missing data. The scale score ranged from 0-100; higher scores indicated fewer symptoms and better health-related quality of life with a negative change indicating a worsening of symptoms. A change of 4 is considered clinically relevant.
- Mean Maximum Observed Plasma Concentration (Cmax; Nanograms Per Milliliter [mg/mL]) of GLPG2222 [ Time Frame: Day 15 (predose and 0.5, 1, 2, 3, 4, 6, and 8 hours postdose) and prior to dosing on Day 29 ]Maximum concentration of GLPG2222 after multiple dosing (ng/ML), obtained directly from the observed concentration versus time data. All pharmacokinetic (PK) parameters were determined from Day 15; Day 29 data were determined if the participant was not available for full PK profiling on Day 15.
- Mean GLPG2222 Plasma Concentration Observed at Predose (Ctrough; ng/mL) [ Time Frame: Days 15 and 29 (predose) ]Plasma concentration of GLPG2222 observed at pre-dose (ng/mL), obtained directly from the observed concentration versus time data. Ctrough was calculated using both Day 15 and Day 29 PK data.
- Median Time to Occurrence of GLPG2222 Cmax (Tmax; Hours [h]) [ Time Frame: Day 15 (predose and 0.5, 1, 2, 3, 4, 6, and 8 hours postdose) and prior to dosing on Day 29 ]Time of occurrence of maximum concentration of GLPG2222 after multiple dosing (h), obtained directly from the observed concentration versus time data. All PK parameters were determined from Day 15; Day 29 data were determined if the participant was not available for full PK profiling on Day 15.
- Mean Area Under the Concentration-Time Curve From Time 0 up to 24 Hours Following Multiple Dosing (AUC[0-t]; ng.h/mL) of GLPG2222 [ Time Frame: Day 15 (predose and 0.5, 1, 2, 3, 4, 6, and 8 hours postdose) and prior to dosing on Day 29 ]Area under the concentration-time curve from time 0 up to 24 hours following multiple dosing (ng.h/mL), calculated by linear up/log down trapezoidal summation. All PK parameters were determined from Day 15; Day 29 data were determined if the participant was not available for full PK profiling on Day 15.
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| Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or female subject ≥ 18 years of age, on the day of signing the Informed Consent Form (ICF).
- A confirmed clinical diagnosis of CF and homozygous for the F508del CFTR mutation
- Weight ≥ 40 kg.
- Stable concomitant treatment for at least 4 weeks (28 days) prior to baseline
- Forced expiratory volume in 1 second (FEV1) ≥ 40% of predicted normal for age, gender and height at screening
Exclusion Criteria:
- History of clinically meaningful unstable or uncontrolled chronic disease that makes the subject unsuitable for inclusion in the study in the opinion of the investigator.
- Unstable pulmonary status or respiratory tract infection requiring a change in therapy within 4 weeks of baseline.
- Need for supplemental oxygen during the day, and >2 liters per minute (LPM) while sleeping.
- Use of CFTR modulator therapy (e.g. lumacaftor or ivacaftor) within 4 weeks prior to the first study drug administration.
- History of hepatic cirrhosis with portal hypertension.
- Abnormal liver function test at screening; defined as aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) and/ or alkaline phosphatase and/or gamma-glutamyl transferase (GGT) ≥ 3x the upper limit of normal (ULN); and/or total bilirubin (>1.5 times ULN)
- Estimated creatinine clearance < 60 mL/min using the Cockcroft-Gault formula at screening.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03119649
Locations
Show 23 study locations
Sponsors and Collaborators
Galapagos NV
Investigators
| Study Director: | Olivier Van Steen, MD, MBA | Galapagos NV |
Study Documents (Full-Text)
Documents provided by Galapagos NV:
Documents provided by Galapagos NV:
Study Protocol [PDF] December 6, 2016
Statistical Analysis Plan [PDF] November 10, 2017
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Galapagos NV |
| ClinicalTrials.gov Identifier: | NCT03119649 |
| Other Study ID Numbers: |
GLPG2222-CL-202 |
| First Posted: | April 18, 2017 Key Record Dates |
| Results First Posted: | November 16, 2018 |
| Last Update Posted: | November 16, 2018 |
| Last Verified: | October 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Cystic Fibrosis Fibrosis Pathologic Processes Pancreatic Diseases Digestive System Diseases |
Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases |