Idiopathic Pulmonary Fibrosis
Conditions
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).
Interventions
DRUGGLPG1205
GLPG1205 will be provided as an oral hard gelatin capsule.
DRUGPlacebo
GLPG1205 matching placebo will be provided as an oral hard gelatin capsule.
Sponsors
Galapagos NV
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants who meet all of the following criteria are eligible for the study: * A diagnosis of IPF within 5 years prior to the screening visit as per applicable American Thoracic Society (ATS)/European Respiratory Society(ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Association (ALAT) guideline. Participants receiving local standard of care for the treatment of IPF, defined as either pirfenidone or nintedanib at a stable dose for at least 8 weeks before screening, and during screening; or neither pirfenidone nor nintedanib (for any reason). A stable dose is defined as the highest tolerated dose. Prednisone at steady dose less than or equal to 10 mg/day or equivalent glucocorticoid dose is allowed (stabilized 4 weeks prior to screening and continued without variation of dose or regimen). Supportive care like supplemental oxygen or pulmonary rehabilitation is allowed. * Meeting all of the following criteria at screening and during the screening period: * Forced vital capacity (FVC) greater than or equal to 50% predicted of normal * Disease progression, defined as a decline of FVC (% predicted or milliliters \[mL\]) at the investigator's discretion, during the 9 months prior to the screening period and confirmed at the screening visit * Diffusing capacity for the lungs for carbon monoxide (DLCO) greater than or equal to 30% predicted of normal (corrected for hemoglobin) * Ratio of forced expiratory volume in one second (FEV1) to FVC greater than or equal to 0.70 * In a stable condition and suitable for study participation based on the results of a medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and laboratory evaluation. Stable condition is based on the clinical judgment of the investigator, co-morbidities should be treated according to the local applicable guidelines. Concomitant medication for chronic comorbidities should be stabilized from 4 weeks before screening and during the screening period (stable defined as no clinically relevant change according to the investigator's judgement). * Able to walk at least 150 meters during the 6 Minute Walk Test (6MWT) at screening; without having a contraindication to perform the 6MWT. This list only describes the key inclusion criteria.
Exclusion criteria
Participants meeting one or more of the following criteria cannot be selected for this study: * Known hypersensitivity to any of the investigational medicinal product (IMP) ingredients or a history of a significant allergic reaction to any drug as determined by the investigator (e.g. anaphylaxis requiring hospitalization). * Current immunosuppressive condition (e.g. human immunodeficiency virus \[HIV\] infection, congenital, acquired, medication induced, organ transplantation). * Positive blood testing for hepatitis B surface antigen (HBS Ag) or hepatitis C virus (HCV) antibody (if positive, confirmed by HCV ribonucleic acid \[RNA\] positivity). Note: Participants with a resolved hepatitis A at least 3 months prior to first dosing of the IMP can be included. * History of malignancy within the past 5 years (except for carcinoma in situ of the uterine cervix, basal cell carcinoma of the skin that has been treated with no evidence of recurrence, and prostate cancer medically managed through active surveillance or watchful waiting, and squamous cell carcinoma of the skin if fully resected). * Acute IPF exacerbation within 3 months prior to screening and during the screening period. * Lower respiratory tract infection requiring antibiotics within 4 weeks prior to screening and/or during the screening period. * Interstitial lung disease associated with known primary diseases (e.g. sarcoidosis, amyloidosis), exposures (e.g. radiation, silica, asbestos, coal dust), and drugs (e.g. amiodarone). * History of lung volume reduction surgery or lung transplant. * Unstable cardiovascular, pulmonary (other than IPF) or other disease within 6 months prior to screening or during the screening period (e.g. coronary heart disease, heart failure, stroke). * Participant participating in a drug, device or biologic investigational research study, concurrently with the current study, within 12 weeks or 5-half-lives of the agent, whichever is longer, prior to screening, or prior participation in an investigational drug antibody/biologic study within 6 months prior to screening. This list only describes the key
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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). |
| 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. |
Countries
Bulgaria, Croatia, Finland, France, Oman, Romania, Slovakia, Sweden, Ukraine
Participant flow
Recruitment details
Participants were enrolled at study sites in Bulgaria, Croatia, Finland, France, Oman, Romania, Slovakia, Sweden, and Ukraine. The first participant was screened on 27 Sep 2018. The last study visit occurred on 14 Aug 2020.
Pre-assignment details
A total of 155 participants were screened, of which 86 participants were considered ineligible. Out of 69 enrolled participants, 1 participant met an exclusion criterion pre-dose and was therefore excluded.
Participants by arm
| Arm | Count |
|---|---|
| GLPG1205 100 mg Participants received GLPG1205 100 mg (2 capsules x 50 mg), orally once daily for 26 weeks in addition to the local standard of care. Standard of care included nintedanib, pirfenidone, or neither nintedanib nor pirfenidone. | 45 |
| Placebo Participants received GLPG1205 matching placebo, orally once daily (as 2 capsules) for 26 weeks in addition to the local standard of care. Standard of care included nintedanib, pirfenidone, or neither nintedanib nor pirfenidone. | 23 |
| Total | 68 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Travel restrictions due to COVID-19 | 2 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Placebo | Total | GLPG1205 100 mg |
|---|---|---|---|
| Age, Continuous | 68.3 years STANDARD_DEVIATION 5.5 | 69.8 years STANDARD_DEVIATION 6.4 | 70.5 years STANDARD_DEVIATION 6.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants | 68 Participants | 45 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 17 Participants | 11 Participants |
| Race (NIH/OMB) White | 17 Participants | 49 Participants | 32 Participants |
| Sex: Female, Male Female | 6 Participants | 18 Participants | 12 Participants |
| Sex: Female, Male Male | 17 Participants | 50 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 45 | 0 / 23 |
| other Total, other adverse events | 36 / 45 | 18 / 23 |
| serious Total, serious adverse events | 9 / 45 | 1 / 23 |
Outcome results
Primary
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
Population: Participants in the full analysis set (FAS) (consisted of all randomized participants who received at least 1 dose of the study drug) with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GLPG1205 100 mg | Change From Baseline in Forced Vital Capacity (FVC) at Week 26 | Baseline | 2865.43 mL | Standard Error 103.544 |
| GLPG1205 100 mg | Change From Baseline in Forced Vital Capacity (FVC) at Week 26 | Change at Week 26 | -31.29 mL | Standard Error 42.398 |
| Placebo | Change From Baseline in Forced Vital Capacity (FVC) at Week 26 | Baseline | 2817.08 mL | Standard Error 167.773 |
| Placebo | Change From Baseline in Forced Vital Capacity (FVC) at Week 26 | Change at Week 26 | -79.47 mL | Standard Error 32.838 |
Comparison: Change at Week 26p-value: 0.49595% CI: [-81.84, 166.49]ANCOVA
Secondary
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
Population: Participants in the FAS population with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GLPG1205 100 mg | Change From Baseline in SGRQ Domain Score at Week 26 | Baseline (symptoms score) | 49.454 units on a scale | Standard Error 3.7439 |
| GLPG1205 100 mg | Change From Baseline in SGRQ Domain Score at Week 26 | Change at Week 26 (symptoms score) | -3.135 units on a scale | Standard Error 2.6281 |
| GLPG1205 100 mg | Change From Baseline in SGRQ Domain Score at Week 26 | Baseline (activity score) | 58.243 units on a scale | Standard Error 3.0224 |
| GLPG1205 100 mg | Change From Baseline in SGRQ Domain Score at Week 26 | Change at Week 26 (activity score) | -4.387 units on a scale | Standard Error 3.5367 |
| GLPG1205 100 mg | Change From Baseline in SGRQ Domain Score at Week 26 | Baseline (impacts score) | 36.409 units on a scale | Standard Error 3.1765 |
| GLPG1205 100 mg | Change From Baseline in SGRQ Domain Score at Week 26 | Change at Week 26 (impacts score) | -3.460 units on a scale | Standard Error 3.133 |
| Placebo | Change From Baseline in SGRQ Domain Score at Week 26 | Baseline (impacts score) | 40.064 units on a scale | Standard Error 4.2897 |
| Placebo | Change From Baseline in SGRQ Domain Score at Week 26 | Baseline (symptoms score) | 56.059 units on a scale | Standard Error 4.3333 |
| Placebo | Change From Baseline in SGRQ Domain Score at Week 26 | Change at Week 26 (activity score) | 1.156 units on a scale | Standard Error 3.6228 |
| Placebo | Change From Baseline in SGRQ Domain Score at Week 26 | Change at Week 26 (symptoms score) | -3.437 units on a scale | Standard Error 4.4017 |
| Placebo | Change From Baseline in SGRQ Domain Score at Week 26 | Change at Week 26 (impacts score) | -1.412 units on a scale | Standard Error 3.2971 |
| Placebo | Change From Baseline in SGRQ Domain Score at Week 26 | Baseline (activity score) | 59.454 units on a scale | Standard Error 4.614 |
Comparison: Change at Week 26: Symptoms scorep-value: 0.87595% CI: [-9.98, 8.53]ANCOVA
Comparison: Change at Week 26: Activity scorep-value: 0.41695% CI: [-14.29, 6.02]ANCOVA
Comparison: Change at Week 26: Impacts scorep-value: 0.96195% CI: [-8.32, 7.92]ANCOVA
Secondary
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
Population: Participants in the FAS population with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GLPG1205 100 mg | Change From Baseline in St.George's Respiratory Questionnaire (SGRQ) Total Score at Week 26 | Baseline | 45.363 units on a scale | Standard Error 2.8518 |
| GLPG1205 100 mg | Change From Baseline in St.George's Respiratory Questionnaire (SGRQ) Total Score at Week 26 | Change at Week 26 | -3.797 units on a scale | Standard Error 2.6683 |
| Placebo | Change From Baseline in St.George's Respiratory Questionnaire (SGRQ) Total Score at Week 26 | Baseline | 48.599 units on a scale | Standard Error 3.9497 |
| Placebo | Change From Baseline in St.George's Respiratory Questionnaire (SGRQ) Total Score at Week 26 | Change at Week 26 | -1.424 units on a scale | Standard Error 2.7151 |
Comparison: Change at Week 26p-value: 0.67395% CI: [-9.06, 5.91]ANCOVA
Secondary
Change From Baseline in Total Distance Walked in Six-minute Walk Test (6MWT) at Week 26
The 6-MWT depicts the total distance covered by a participant during 6 minutes of walking.
Time frame: Baseline, Week 26
Population: Participants in the FAS population with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GLPG1205 100 mg | Change From Baseline in Total Distance Walked in Six-minute Walk Test (6MWT) at Week 26 | Baseline | 412.6 meters | Standard Error 18.53 |
| GLPG1205 100 mg | Change From Baseline in Total Distance Walked in Six-minute Walk Test (6MWT) at Week 26 | Change at Week 26 | -16.6 meters | Standard Error 10.56 |
| Placebo | Change From Baseline in Total Distance Walked in Six-minute Walk Test (6MWT) at Week 26 | Baseline | 391.8 meters | Standard Error 25.72 |
| Placebo | Change From Baseline in Total Distance Walked in Six-minute Walk Test (6MWT) at Week 26 | Change at Week 26 | -8.7 meters | Standard Error 10.43 |
Comparison: Change at Week 26p-value: 0.56595% CI: [-40.87, 22.64]ANCOVA
Secondary
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)
Population: Participants in the FAS population were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GLPG1205 100 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Related to Study Drug, and TEAEs Leading to Study Drug Discontinuation | TEAEs | 36 participants |
| GLPG1205 100 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Related to Study Drug, and TEAEs Leading to Study Drug Discontinuation | Serious TEAEs | 9 participants |
| GLPG1205 100 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Related to Study Drug, and TEAEs Leading to Study Drug Discontinuation | TEAEs related to study drug | 20 participants |
| GLPG1205 100 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Related to Study Drug, and TEAEs Leading to Study Drug Discontinuation | TEAEs leading to study drug discontinuation | 10 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Related to Study Drug, and TEAEs Leading to Study Drug Discontinuation | TEAEs leading to study drug discontinuation | 0 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Related to Study Drug, and TEAEs Leading to Study Drug Discontinuation | TEAEs | 18 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Related to Study Drug, and TEAEs Leading to Study Drug Discontinuation | TEAEs related to study drug | 3 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Related to Study Drug, and TEAEs Leading to Study Drug Discontinuation | Serious TEAEs | 1 participants |
Comparison: TEAEs95% CI: [-17.3, 24.5]
Comparison: Serious TEAEs95% CI: [-3, 30.7]
Comparison: TEAEs related to study drug95% CI: [8.2, 49.4]
Comparison: TEAEs leading to study drug discontinuation95% CI: [6.7, 36.4]
Secondary
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
Population: Participants in the FAS population with available data were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GLPG1205 100 mg | Percentage of SGRQ Responders | 40.0 percentage of participants |
| Placebo | Percentage of SGRQ Responders | 40.9 percentage of participants |
p-value: 1Fisher Exact
Secondary
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)
Population: Participants in the pharmacokinetic (PK) analysis set (a subset of the FAS, including all participants who had available and evaluable plasma concentration data, excluding all protocol deviations or AEs that may have had an impact on the PK analysis) with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GLPG1205 100 mg | Pre-dose Plasma Concentration (Ctrough) of GLPG1205 at Week 26 | 4979.9 nanograms per milliliter (ng/mL) | Standard Deviation 2279.5 |
Secondary
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)
Population: Participants in the PK analysis set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GLPG1205 100 mg | Pre-dose Plasma Concentration (Ctrough) of Nintedanib at Week 20 | 14.58 ng/mL | Standard Deviation 6.69 |
| Placebo | Pre-dose Plasma Concentration (Ctrough) of Nintedanib at Week 20 | 14.17 ng/mL | Standard Deviation 18.65 |
Secondary
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)
Population: Participants in the PK analysis set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GLPG1205 100 mg | Pre-dose Plasma Concentration (Ctrough) of Pirfenidone at Week 20 | 3701.0 ng/mL | Standard Deviation 3583.1 |
| Placebo | Pre-dose Plasma Concentration (Ctrough) of Pirfenidone at Week 20 | 2313.0 ng/mL | Standard Deviation 1957 |
Secondary
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
Population: Participants in the FAS population were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GLPG1205 100 mg | 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 | All-cause deaths | 3.1 percentage of participants |
| GLPG1205 100 mg | 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 | Respiratory-related deaths | 3.1 percentage of participants |
| GLPG1205 100 mg | 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 | All-cause hospitalizations | 16.6 percentage of participants |
| GLPG1205 100 mg | 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 | Respiratory-related hospitalizations | 2.8 percentage of participants |
| Placebo | 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 | Respiratory-related hospitalizations | 4.3 percentage of participants |
| Placebo | 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 | All-cause deaths | 0 percentage of participants |
| Placebo | 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 | All-cause hospitalizations | 4.3 percentage of participants |
| Placebo | 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 | Respiratory-related deaths | 0 percentage of participants |
Comparison: All-cause deathsp-value: 0.397Log Rank
Comparison: Respiratory-related deathsp-value: 0.397Log Rank
Comparison: All-cause hospitalizationsp-value: 0.131Log Rank
Comparison: Respiratory-related hospitalizationsp-value: 0.762Log Rank