A Clinical Study to Test How Effective and Safe GLPG1205 is for Participants With Idiopathic Pulmonary Fibrosis (IPF)
- Registration Number
- NCT03725852
- Lead Sponsor
- Galapagos NV
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 68
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description GLPG1205 100 mg GLPG1205 Participants will receive GLPG1205 100 milligrams (mg) (2 capsules x 50 mg), orally once daily for 26 weeks in addition to the local standard of care. Standard of care includes nintedanib, pirfenidone, or neither nintedanib nor pirfenidone. Placebo Placebo Participants will receive GLPG1205 matching placebo, orally once daily (as 2 capsules) for 26 weeks in addition to the local standard of care. Standard of care includes nintedanib, pirfenidone, or neither nintedanib nor pirfenidone.
- Primary Outcome Measures
Name Time Method Change From Baseline in Forced Vital Capacity (FVC) at Week 26 Baseline, 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.
- Secondary Outcome Measures
Name Time Method Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Related to Study Drug, and TEAEs Leading to Study Drug Discontinuation First dose date up to 30 days after the last dose of study drug (maximum up to 263 days) 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 to Any Major Events Depicted by Cumulative Percentage of Participants With All-cause Deaths, Respiratory-related Deaths, All-cause Hospitalizations, and Respiratory-related Hospitalizations Day 1 up to Week 30 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.
Change From Baseline in Total Distance Walked in Six-minute Walk Test (6MWT) at Week 26 Baseline, Week 26 The 6-MWT depicts the total distance covered by a participant during 6 minutes of walking.
Change From Baseline in St.George's Respiratory Questionnaire (SGRQ) Total Score at Week 26 Baseline, 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.
Change From Baseline in SGRQ Domain Score at Week 26 Baseline, 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.
Percentage of SGRQ Responders Baseline up to 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 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.
Pre-dose Plasma Concentration (Ctrough) of GLPG1205 at Week 26 Week 26 (pre-dose) GLPG1205 pre-dose plasma concentration (Ctrough) at Week 26 was reported applying the exclusion rules (e.g. dose reduction, discontinuation, samples flagged).
Pre-dose Plasma Concentration (Ctrough) of Nintedanib at Week 20 Week 20 (pre-dose) Nintedanib pre-dose plasma concentration (Ctrough) at Week 20 was reported applying the exclusion rules (e.g. dose reduction, discontinuation, samples flagged).
Pre-dose Plasma Concentration (Ctrough) of Pirfenidone at Week 20 Week 20 (pre-dose) Pirfenidone pre-dose plasma concentration (Ctrough) at Week 20 was reported applying the exclusion rules (e.g. dose reduction, discontinuation, samples flagged).
Trial Locations
- Locations (36)
The Ivano-Frankivsk National Medical Univeristy
🇺🇦Ivano-Frankivs'k, Ukraine
Municipal Institution "Kherson city clinical hospital named after E.E. Karabelesh"
🇺🇦Kherson, Ukraine
Odessa Regional Hospital
🇺🇦Odessa, Ukraine
SHATPPD Dr. Dimitar Gramatikov, Ruse Ltd.
🇧🇬Ruse, Bulgaria
Acibadem City Clinic Tokuda Hospital, EAD
🇧🇬Sofia, Bulgaria
Klinicki Bolnicki Centar Rijeka - Susak
🇭🇷Rijeka, Croatia
Klinička Bolnica Dubrava
🇭🇷Zagreb, Croatia
Hôpital Albert Calmette
🇫🇷Lille, France
Helsinki University Hospital Heart and Lung Center
🇫🇮Helsinki, Finland
Klinički Bolnički Centar Zagreb - Klinika Za Plućne Bolesti Jordanovac
🇭🇷Zagreb, Croatia
ZAPA JJ s.r.o.
🇸🇰Levice, Slovakia
Tampere University Hospital
🇫🇮Tampere, Finland
Specialized Hospital for Active Treatment Pleven
🇧🇬Pleven, Bulgaria
CHU de Lyon - Hôpital Louis Pradel
🇫🇷Bron, France
CHU de Grenoble
🇫🇷La Tronche, France
Hôpital Avicenne
🇫🇷Bobigny, France
Hôpital Larrey
🇫🇷Toulouse, France
CHU de Brest - Hôpital Cavale Blanche
🇫🇷Brest, France
Hôpitaux Prives de Metz (HPMetz) - Hôpital Robert Schuman
🇫🇷Vantoux, France
CHRU de Tours - Hôpital Bretonneau
🇫🇷Tours, France
Hôpital Européen Georges Pompidou (HEGP)
🇫🇷Paris, France
CHU de Nice - Hôpital Pasteur
🇫🇷Nice, France
National Oncology Centre - The Royal Hospital Muscat
🇴🇲Muscat, Oman
Institutul de Pneumoftiziologie Marius Nasta
🇷🇴Bucuresti, Romania
Spitalul Clinic De Pneumoftiziologie Leon Daniello Cluj-Napoca
🇷🇴Cluj-Napoca, Romania
Clinica Medicala Lavinia Davidescu
🇷🇴Oradea, Romania
Spitalul Clinic de Pneumoftiziologie Iasi
🇷🇴Iaşi, Romania
Akademiska Sjukhuset - Uppsala Centrum for Cystisk Fibros
🇸🇪Uppsala, Sweden
Pľúcna Ambulancia Hrebenár, s.r.o.
🇸🇰Spišská Nová Ves, Slovakia
Karolinska Universitetssjukhuset
🇸🇪Stockholm, Sweden
Universitetssjukhuset i Lund
🇸🇪Lund, Sweden
National Institute of Tuberculosis, Pulmonary Diseases and Chest Surgery
🇸🇰Vyšné Hágy, Slovakia
Dnipropetrovsk State Medical Academy - Dnipropetrovsk City Clinical Hospital No. 6
🇺🇦Dnipropetrovsk, Ukraine
National Institute of Phthisiology and Pulmonology named after F.G. Yanovskyi of NAMS of Ukraine
🇺🇦Kyiv, Ukraine
Communal Nonprofit Enterprise City Clinical Hospital
🇺🇦Kharkiv, Ukraine
Vinnitsa Regional Clinical Hospital im. N.I. Pirogov
🇺🇦Vinnytsia, Ukraine