This is a randomized, double-blind, parallel-group, placebo-controlled, multicenter, exploratory Phase 2 study including participants with Idiopathic Pulmonary Fibrosis (IPF), investigating GLPG1205 in addition to the local standard of care (defined as receiving nintedanib, pirfenidone, or neither nintedanib nor pirfenidone).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
68
Change From Baseline in Forced Vital Capacity (FVC) at Week 26
Forced vital capacity (FVC) (in milliliter \[mL\]) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.
Time frame: Baseline, Week 26
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Related to Study Drug, and TEAEs Leading to Study Drug Discontinuation
An adverse event (AE) was any untoward medical occurrence in a participant administered study drug and which did not necessarily have a causal relationship with study drug. A TEAE was any AE with an onset date on or after the start of study drug intake and no later than 30 days after last dose of study drug, or any worsening of any AE on or after the start of study drug intake. A serious AE was defined as an AE that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was medically significant.
Time frame: First dose date up to 30 days after the last dose of study drug (maximum up to 263 days)
Time to Any Major Events Depicted by Cumulative Percentage of Participants With All-cause Deaths, Respiratory-related Deaths, All-cause Hospitalizations, and Respiratory-related Hospitalizations
Treatment effect on time to death (all-cause and respiratory-related)/hospitalization (all-cause and respiratory-related) were assessed using the log-rank test. Kaplan-Meier estimates were derived for the probability of death (all-cause and respiratory-related)/hospitalization (all-cause and respiratory-related). Cumulative percentage of participants with all-cause deaths, respiratory-related deaths, all-cause hospitalizations, and respiratory-related hospitalizations were reported.
Time frame: Day 1 up to Week 30
Change From Baseline in Total Distance Walked in Six-minute Walk Test (6MWT) at Week 26
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Specialized Hospital for Active Treatment Pleven
Pleven, Bulgaria
SHATPPD Dr. Dimitar Gramatikov, Ruse Ltd.
Rousse, Bulgaria
Acibadem City Clinic Tokuda Hospital, EAD
Sofia, Bulgaria
Klinicki Bolnicki Centar Rijeka - Susak
Rijeka, Croatia
Klinička Bolnica Dubrava
Zagreb, Croatia
Klinički Bolnički Centar Zagreb - Klinika Za Plućne Bolesti Jordanovac
Zagreb, Croatia
Helsinki University Hospital Heart and Lung Center
Helsinki, Finland
Tampere University Hospital
Tampere, Finland
Hôpital Avicenne
Bobigny, France
CHU de Brest - Hôpital Cavale Blanche
Brest, France
...and 26 more locations
The 6-MWT depicts the total distance covered by a participant during 6 minutes of walking.
Time frame: Baseline, Week 26
Change From Baseline in St.George's Respiratory Questionnaire (SGRQ) Total Score at Week 26
The SGRQ is a 50-item paper questionnaire designed to measure and quantify the impact of chronic respiratory disease on health-related quality of life (QOL) and well-being, split into 3 domains: symptoms (assessing the frequency and severity of respiratory symptoms), activity (assessing the effects of breathlessness on mobility and physical activity), and impact (assessing the psychosocial impact of the disease). Scores were weighted such that each domain score and the total score ranged from 0 to 100, with higher scores indicating the poorer health-related QOL.
Time frame: Baseline, Week 26
Change From Baseline in SGRQ Domain Score at Week 26
The SGRQ is a 50-item paper questionnaire designed to measure and quantify the impact of chronic respiratory disease on health-related QOL and well-being, split into 3 domains: symptoms (assessing the frequency and severity of respiratory symptoms), activity (assessing the effects of breathlessness on mobility and physical activity), and impact (assessing the psychosocial impact of the disease). Scores were weighted such that each domain score ranged from 0 to 100, with higher scores indicating the poorer health-related QOL.
Time frame: Baseline, Week 26
Percentage of SGRQ Responders
The SGRQ is a 50-item paper questionnaire designed to measure and quantify the impact of chronic respiratory disease on health-related QOL and well-being, split into 3 domains: symptoms (assessing the frequency and severity of respiratory symptoms), activity (assessing the effects of breathlessness on mobility and physical activity), and impact (assessing the psychosocial impact of the disease). Scores were weighted such that each domain score and total score ranged from 0 to 100, with higher scores indicating the poorer health-related QOL. SGRQ responders are those with absolute change from baseline in SGRQ total score less than or equal to -4 percent (%) at least once.
Time frame: Baseline up to Week 26
Pre-dose Plasma Concentration (Ctrough) of GLPG1205 at Week 26
GLPG1205 pre-dose plasma concentration (Ctrough) at Week 26 was reported applying the exclusion rules (e.g. dose reduction, discontinuation, samples flagged).
Time frame: Week 26 (pre-dose)
Pre-dose Plasma Concentration (Ctrough) of Nintedanib at Week 20
Nintedanib pre-dose plasma concentration (Ctrough) at Week 20 was reported applying the exclusion rules (e.g. dose reduction, discontinuation, samples flagged).
Time frame: Week 20 (pre-dose)
Pre-dose Plasma Concentration (Ctrough) of Pirfenidone at Week 20
Pirfenidone pre-dose plasma concentration (Ctrough) at Week 20 was reported applying the exclusion rules (e.g. dose reduction, discontinuation, samples flagged).
Time frame: Week 20 (pre-dose)