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A Clinical Study to Test How Effective and Safe GLPG1205 is for Participants With Idiopathic Pulmonary Fibrosis (IPF) (PINTA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03725852
Recruitment Status : Completed
First Posted : October 31, 2018
Results First Posted : September 14, 2021
Last Update Posted : September 14, 2021
Sponsor:
Information provided by (Responsible Party):
Galapagos NV

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Idiopathic Pulmonary Fibrosis
Interventions Drug: GLPG1205
Drug: Placebo
Enrollment 68
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.
Arm/Group Title GLPG1205 100 mg Placebo
Hide Arm/Group Description Participants received 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 included nintedanib, pirfenidone, or neither nintedanib nor pirfenidone. 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.
Period Title: Overall Study
Started 45 23
Completed 41 23
Not Completed 4 0
Reason Not Completed
Death             1             0
Withdrawal by Subject             1             0
Travel restrictions due to COVID-19             2             0
Arm/Group Title GLPG1205 100 mg Placebo Total
Hide Arm/Group Description 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 45 23 68
Hide Baseline Analysis Population Description
Full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 45 participants 23 participants 68 participants
70.5  (6.8) 68.3  (5.5) 69.8  (6.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 23 participants 68 participants
Female
12
  26.7%
6
  26.1%
18
  26.5%
Male
33
  73.3%
17
  73.9%
50
  73.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 23 participants 68 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
45
 100.0%
23
 100.0%
68
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 23 participants 68 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
   4.4%
0
   0.0%
2
   2.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
32
  71.1%
17
  73.9%
49
  72.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
11
  24.4%
6
  26.1%
17
  25.0%
1.Primary Outcome
Title Change From Baseline in Forced Vital Capacity (FVC) at Week 26
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title GLPG1205 100 mg Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 45 23
Mean (Standard Error)
Unit of Measure: mL
Baseline Number Analyzed 45 participants 23 participants
2865.43  (103.544) 2817.08  (167.773)
Change at Week 26 Number Analyzed 29 participants 20 participants
-31.29  (42.398) -79.47  (32.838)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GLPG1205 100 mg, Placebo
Comments Change at Week 26
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.495
Comments P-value was based on an analysis of covariance (ANCOVA) model at each time point including treatment, sex, stratum (nintedanib, pirfenidone or neither), age, height, and baseline value as covariates.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square (LS) mean difference
Estimated Value 42.33
Confidence Interval (2-Sided) 95%
-81.84 to 166.49
Parameter Dispersion
Type: Standard Error of the Mean
Value: 61.483
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Related to Study Drug, and TEAEs Leading to Study Drug Discontinuation
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the FAS population were analyzed.
Arm/Group Title GLPG1205 100 mg Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 45 23
Measure Type: Number
Unit of Measure: participants
TEAEs 36 18
Serious TEAEs 9 1
TEAEs related to study drug 20 3
TEAEs leading to study drug discontinuation 10 0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GLPG1205 100 mg, Placebo
Comments TEAEs
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 1.7
Confidence Interval (2-Sided) 95%
-17.3 to 24.5
Estimation Comments 95% CI for difference calculated using the method of Miettinen and Nurminen.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GLPG1205 100 mg, Placebo
Comments Serious TEAEs
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 15.7
Confidence Interval (2-Sided) 95%
-3.0 to 30.7
Estimation Comments 95% CI for difference calculated using the method of Miettinen and Nurminen.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GLPG1205 100 mg, Placebo
Comments TEAEs related to study drug
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 31.4
Confidence Interval (2-Sided) 95%
8.2 to 49.4
Estimation Comments 95% CI for difference calculated using the method of Miettinen and Nurminen.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection GLPG1205 100 mg, Placebo
Comments TEAEs leading to study drug discontinuation
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 22.2
Confidence Interval (2-Sided) 95%
6.7 to 36.4
Estimation Comments 95% CI for difference calculated using the method of Miettinen and Nurminen.
3.Secondary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the FAS population were analyzed.
Arm/Group Title GLPG1205 100 mg Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 45 23
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
All-cause deaths
3.1
(0.4 to 20.2)
0 [1] 
(NA to NA)
Respiratory-related deaths
3.1
(0.4 to 20.2)
0 [1] 
(NA to NA)
All-cause hospitalizations
16.6
(8.3 to 31.9)
4.3
(0.6 to 27.1)
Respiratory-related hospitalizations
2.8
(0.4 to 18.1)
4.3
(0.6 to 27.1)
[1]
Data could not be estimated as all participants in this group were censored.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GLPG1205 100 mg, Placebo
Comments All-cause deaths
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.397
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GLPG1205 100 mg, Placebo
Comments Respiratory-related deaths
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.397
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GLPG1205 100 mg, Placebo
Comments All-cause hospitalizations
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.131
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection GLPG1205 100 mg, Placebo
Comments Respiratory-related hospitalizations
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.762
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Total Distance Walked in Six-minute Walk Test (6MWT) at Week 26
Hide Description The 6-MWT depicts the total distance covered by a participant during 6 minutes of walking.
Time Frame Baseline, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the FAS population with available data were analyzed.
Arm/Group Title GLPG1205 100 mg Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 45 23
Mean (Standard Error)
Unit of Measure: meters
Baseline Number Analyzed 45 participants 23 participants
412.6  (18.53) 391.8  (25.72)
Change at Week 26 Number Analyzed 26 participants 19 participants
-16.6  (10.56) -8.7  (10.43)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GLPG1205 100 mg, Placebo
Comments Change at Week 26
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.565
Comments P-value was based on an ANCOVA model at Week 26 including treatment, stratum (nintedanib, pirfenidone or neither) and baseline 6MWT distance as covariates.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Weighted LS mean difference
Estimated Value -9.11
Confidence Interval (2-Sided) 95%
-40.87 to 22.64
Parameter Dispersion
Type: Standard Error of the Mean
Value: 15.713
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in St.George's Respiratory Questionnaire (SGRQ) Total Score at Week 26
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the FAS population with available data were analyzed.
Arm/Group Title GLPG1205 100 mg Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 45 23
Mean (Standard Error)
Unit of Measure: units on a scale
Baseline Number Analyzed 45 participants 23 participants
45.363  (2.8518) 48.599  (3.9497)
Change at Week 26 Number Analyzed 29 participants 19 participants
-3.797  (2.6683) -1.424  (2.7151)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GLPG1205 100 mg, Placebo
Comments Change at Week 26
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.673
Comments P-value was based on an ANCOVA model at Week 26 including treatment, stratum (nintedanib, pirfenidone or neither) and baseline SGRQ value as covariates.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Weighted LS mean difference.
Estimated Value -1.58
Confidence Interval (2-Sided) 95%
-9.06 to 5.91
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.710
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in SGRQ Domain Score at Week 26
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the FAS population with available data were analyzed.
Arm/Group Title GLPG1205 100 mg Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 45 23
Mean (Standard Error)
Unit of Measure: units on a scale
Baseline (symptoms score) Number Analyzed 45 participants 23 participants
49.454  (3.7439) 56.059  (4.3333)
Change at Week 26 (symptoms score) Number Analyzed 29 participants 19 participants
-3.135  (2.6281) -3.437  (4.4017)
Baseline (activity score) Number Analyzed 45 participants 23 participants
58.243  (3.0224) 59.454  (4.6140)
Change at Week 26 (activity score) Number Analyzed 29 participants 20 participants
-4.387  (3.5367) 1.156  (3.6228)
Baseline (impacts score) Number Analyzed 45 participants 23 participants
36.409  (3.1765) 40.064  (4.2897)
Change at Week 26 (impacts score) Number Analyzed 29 participants 20 participants
-3.460  (3.1330) -1.412  (3.2971)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GLPG1205 100 mg, Placebo
Comments Change at Week 26: Symptoms score
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.875
Comments P-value was based on an ANCOVA model at Week 26 including treatment, stratum (nintedanib, pirfenidone or neither) and baseline SGRQ value as covariates.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Weighted LS mean difference
Estimated Value -0.72
Confidence Interval (2-Sided) 95%
-9.98 to 8.53
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.591
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GLPG1205 100 mg, Placebo
Comments Change at Week 26: Activity score
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.416
Comments P-value was based on an ANCOVA model at Week 26 including treatment, stratum (nintedanib, pirfenidone or neither) and baseline SGRQ value as covariates.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Weighted LS mean difference
Estimated Value -4.14
Confidence Interval (2-Sided) 95%
-14.29 to 6.02
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.038
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GLPG1205 100 mg, Placebo
Comments Change at Week 26: Impacts score
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.961
Comments P-value was based on an ANCOVA model at Week 26 including treatment, stratum (nintedanib, pirfenidone or neither) and baseline SGRQ value as covariates.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Weighted LS mean difference
Estimated Value -0.20
Confidence Interval (2-Sided) 95%
-8.32 to 7.92
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.029
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percentage of SGRQ Responders
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the FAS population with available data were analyzed.
Arm/Group Title GLPG1205 100 mg Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 40 22
Measure Type: Number
Unit of Measure: percentage of participants
40.0 40.9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GLPG1205 100 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
8.Secondary Outcome
Title Pre-dose Plasma Concentration (Ctrough) of GLPG1205 at Week 26
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title GLPG1205 100 mg
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: nanograms per milliliter (ng/mL)
4979.9  (2279.5)
9.Secondary Outcome
Title Pre-dose Plasma Concentration (Ctrough) of Nintedanib at Week 20
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PK analysis set with available data were analyzed.
Arm/Group Title GLPG1205 100 mg Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 4 4
Mean (Standard Deviation)
Unit of Measure: ng/mL
14.58  (6.69) 14.17  (18.65)
10.Secondary Outcome
Title Pre-dose Plasma Concentration (Ctrough) of Pirfenidone at Week 20
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PK analysis set with available data were analyzed.
Arm/Group Title GLPG1205 100 mg Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 4 6
Mean (Standard Deviation)
Unit of Measure: ng/mL
3701.0  (3583.1) 2313.0  (1957.0)
Time Frame First dose date up to 30 days after the last dose of study drug (maximum up to 263 days)
Adverse Event Reporting Description Full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study drug.
 
Arm/Group Title GLPG1205 100 mg Placebo
Hide Arm/Group Description 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. 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.
All-Cause Mortality
GLPG1205 100 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1/45 (2.22%)   0/23 (0.00%) 
Hide Serious Adverse Events
GLPG1205 100 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   9/45 (20.00%)   1/23 (4.35%) 
Blood and lymphatic system disorders     
Neutropenia † 1  1/45 (2.22%)  0/23 (0.00%) 
Normocytic anaemia † 1  1/45 (2.22%)  0/23 (0.00%) 
Cardiac disorders     
Angina pectoris † 1  1/45 (2.22%)  0/23 (0.00%) 
Myocardial ischaemia † 1  1/45 (2.22%)  0/23 (0.00%) 
General disorders     
General physical health deterioration † 1  1/45 (2.22%)  0/23 (0.00%) 
Infections and infestations     
Bronchitis † 1  0/45 (0.00%)  1/23 (4.35%) 
Gastrointestinal viral infection † 1  1/45 (2.22%)  0/23 (0.00%) 
Post procedural infection † 1  1/45 (2.22%)  0/23 (0.00%) 
Musculoskeletal and connective tissue disorders     
Intervertebral disc protrusion † 1  1/45 (2.22%)  0/23 (0.00%) 
Neck pain † 1  1/45 (2.22%)  0/23 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer † 1  1/45 (2.22%)  0/23 (0.00%) 
Nervous system disorders     
Headache † 1  1/45 (2.22%)  0/23 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Interstitial lung disease † 1  1/45 (2.22%)  0/23 (0.00%) 
1
Term from vocabulary, MedDRA Version 23.0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
GLPG1205 100 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   36/45 (80.00%)   18/23 (78.26%) 
Blood and lymphatic system disorders     
Leukocytosis † 1  2/45 (4.44%)  0/23 (0.00%) 
Neutrophilia † 1  2/45 (4.44%)  0/23 (0.00%) 
Immune thrombocytopenia † 1  0/45 (0.00%)  1/23 (4.35%) 
Normocytic anaemia † 1  1/45 (2.22%)  0/23 (0.00%) 
Ear and labyrinth disorders     
Vertigo † 1  1/45 (2.22%)  0/23 (0.00%) 
Eye disorders     
Diplopia † 1  1/45 (2.22%)  0/23 (0.00%) 
Panophthalmitis † 1  0/45 (0.00%)  1/23 (4.35%) 
Gastrointestinal disorders     
Diarrhoea † 1  12/45 (26.67%)  3/23 (13.04%) 
Nausea † 1  13/45 (28.89%)  2/23 (8.70%) 
Abdominal pain † 1  5/45 (11.11%)  0/23 (0.00%) 
Vomiting † 1  4/45 (8.89%)  0/23 (0.00%) 
Abdominal pain upper † 1  3/45 (6.67%)  0/23 (0.00%) 
Constipation † 1  1/45 (2.22%)  1/23 (4.35%) 
Chronic gastritis † 1  1/45 (2.22%)  0/23 (0.00%) 
Dry mouth † 1  1/45 (2.22%)  0/23 (0.00%) 
Dyspepsia † 1  1/45 (2.22%)  0/23 (0.00%) 
Gastric ulcer † 1  1/45 (2.22%)  0/23 (0.00%) 
Gastrooesophageal reflux disease † 1  0/45 (0.00%)  1/23 (4.35%) 
Mucous stools † 1  1/45 (2.22%)  0/23 (0.00%) 
Toothache † 1  0/45 (0.00%)  1/23 (4.35%) 
General disorders     
Asthenia † 1  9/45 (20.00%)  0/23 (0.00%) 
Fatigue † 1  6/45 (13.33%)  0/23 (0.00%) 
Chest pain † 1  1/45 (2.22%)  0/23 (0.00%) 
Hunger † 1  1/45 (2.22%)  0/23 (0.00%) 
Malaise † 1  1/45 (2.22%)  0/23 (0.00%) 
Pyrexia † 1  1/45 (2.22%)  0/23 (0.00%) 
Thirst † 1  1/45 (2.22%)  0/23 (0.00%) 
Hepatobiliary disorders     
Cholelithiasis † 1  1/45 (2.22%)  0/23 (0.00%) 
Hepatic mass † 1  1/45 (2.22%)  0/23 (0.00%) 
Hepatic steatosis † 1  1/45 (2.22%)  0/23 (0.00%) 
Hyperbilirubinaemia † 1  0/45 (0.00%)  1/23 (4.35%) 
Infections and infestations     
Nasopharyngitis † 1  6/45 (13.33%)  4/23 (17.39%) 
Bronchitis † 1  3/45 (6.67%)  3/23 (13.04%) 
Diarrhoea infectious † 1  1/45 (2.22%)  0/23 (0.00%) 
Erythema migrans † 1  0/45 (0.00%)  1/23 (4.35%) 
Gastroenteritis † 1  1/45 (2.22%)  0/23 (0.00%) 
Gastrointestinal viral infection † 1  1/45 (2.22%)  0/23 (0.00%) 
Gingival abscess † 1  1/45 (2.22%)  0/23 (0.00%) 
Kidney infection † 1  1/45 (2.22%)  0/23 (0.00%) 
Laryngitis † 1  1/45 (2.22%)  0/23 (0.00%) 
Oral candidiasis † 1  1/45 (2.22%)  0/23 (0.00%) 
Oral fungal infection † 1  0/45 (0.00%)  1/23 (4.35%) 
Oral herpes † 1  0/45 (0.00%)  1/23 (4.35%) 
Pneumonia † 1  1/45 (2.22%)  0/23 (0.00%) 
Respiratory tract infection † 1  0/45 (0.00%)  1/23 (4.35%) 
Sinusitis † 1  0/45 (0.00%)  1/23 (4.35%) 
Tracheitis † 1  1/45 (2.22%)  0/23 (0.00%) 
Upper respiratory tract infection † 1  0/45 (0.00%)  1/23 (4.35%) 
Injury, poisoning and procedural complications     
Radius fracture † 1  1/45 (2.22%)  0/23 (0.00%) 
Rib fracture † 1  1/45 (2.22%)  0/23 (0.00%) 
Thermal burn † 1  1/45 (2.22%)  0/23 (0.00%) 
Investigations     
Weight decreased † 1  6/45 (13.33%)  1/23 (4.35%) 
Alanine aminotransferase increased † 1  3/45 (6.67%)  0/23 (0.00%) 
Aspartate aminotransferase increased † 1  3/45 (6.67%)  0/23 (0.00%) 
Gamma-glutamyltransferase increased † 1  3/45 (6.67%)  0/23 (0.00%) 
Blood bilirubin increased † 1  2/45 (4.44%)  0/23 (0.00%) 
Blood lactate dehydrogenase increased † 1  2/45 (4.44%)  0/23 (0.00%) 
Blood pressure increased † 1  2/45 (4.44%)  0/23 (0.00%) 
Blood alkaline phosphatase increased † 1  1/45 (2.22%)  0/23 (0.00%) 
Brain natriuretic peptide increased † 1  1/45 (2.22%)  0/23 (0.00%) 
Neutrophil count increased † 1  1/45 (2.22%)  0/23 (0.00%) 
White blood cell count increased † 1  1/45 (2.22%)  0/23 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite † 1  5/45 (11.11%)  0/23 (0.00%) 
Appetite disorder † 1  1/45 (2.22%)  0/23 (0.00%) 
Dyslipidaemia † 1  1/45 (2.22%)  0/23 (0.00%) 
Hyperkalaemia † 1  1/45 (2.22%)  0/23 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain † 1  3/45 (6.67%)  1/23 (4.35%) 
Myalgia † 1  2/45 (4.44%)  1/23 (4.35%) 
Arthralgia † 1  1/45 (2.22%)  0/23 (0.00%) 
Intervertebral disc protrusion † 1  1/45 (2.22%)  0/23 (0.00%) 
Muscular weakness † 1  1/45 (2.22%)  0/23 (0.00%) 
Neck pain † 1  1/45 (2.22%)  0/23 (0.00%) 
Osteoarthritis † 1  0/45 (0.00%)  1/23 (4.35%) 
Pain in extremity † 1  1/45 (2.22%)  0/23 (0.00%) 
Nervous system disorders     
Headache † 1  11/45 (24.44%)  4/23 (17.39%) 
Dizziness † 1  6/45 (13.33%)  2/23 (8.70%) 
Burning sensation † 1  1/45 (2.22%)  0/23 (0.00%) 
Dyskinesia † 1  1/45 (2.22%)  0/23 (0.00%) 
Paraesthesia † 1  0/45 (0.00%)  1/23 (4.35%) 
Parkinson's disease † 1  1/45 (2.22%)  0/23 (0.00%) 
Somnolence † 1  1/45 (2.22%)  0/23 (0.00%) 
Tremor † 1  1/45 (2.22%)  0/23 (0.00%) 
Psychiatric disorders     
Anxiety † 1  2/45 (4.44%)  0/23 (0.00%) 
Insomnia † 1  2/45 (4.44%)  0/23 (0.00%) 
Depression † 1  1/45 (2.22%)  0/23 (0.00%) 
Hallucination † 1  1/45 (2.22%)  0/23 (0.00%) 
Irritability † 1  1/45 (2.22%)  0/23 (0.00%) 
Renal and urinary disorders     
Polyuria † 1  2/45 (4.44%)  0/23 (0.00%) 
Renal pain † 1  1/45 (2.22%)  0/23 (0.00%) 
Reproductive system and breast disorders     
Prostatitis † 1  0/45 (0.00%)  1/23 (4.35%) 
Respiratory, thoracic and mediastinal disorders     
Cough † 1  6/45 (13.33%)  2/23 (8.70%) 
Dyspnoea † 1  5/45 (11.11%)  2/23 (8.70%) 
Epistaxis † 1  0/45 (0.00%)  2/23 (8.70%) 
Idiopathic pulmonary fibrosis † 1  1/45 (2.22%)  0/23 (0.00%) 
Interstitial lung disease † 1  1/45 (2.22%)  0/23 (0.00%) 
Oropharyngeal pain † 1  1/45 (2.22%)  0/23 (0.00%) 
Rhinitis allergic † 1  1/45 (2.22%)  0/23 (0.00%) 
Skin and subcutaneous tissue disorders     
Pruritus † 1  3/45 (6.67%)  0/23 (0.00%) 
Rash † 1  2/45 (4.44%)  1/23 (4.35%) 
Erythema † 1  0/45 (0.00%)  1/23 (4.35%) 
Papule † 1  0/45 (0.00%)  1/23 (4.35%) 
Photosensitivity reaction † 1  0/45 (0.00%)  1/23 (4.35%) 
Surgical and medical procedures     
Tooth extraction † 1  1/45 (2.22%)  0/23 (0.00%) 
Vascular disorders     
Hypertension † 1  3/45 (6.67%)  1/23 (4.35%) 
1
Term from vocabulary, MedDRA Version 23.0
†
Indicates events were collected by systematic assessment
The study was not powered to detect statistical significance and was limited by its small sample size, high variability of the primary endpoint (FVC), and a high rate of early treatment discontinuations.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The sponsor must review and approve any results of the study or abstracts for professional meetings prepared by the investigator(s). Published data must not compromise the objectives of the study. Data from individual study centers in multicenter studies must not be published separately.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Galapagos Medical Information
Organization: Galapagos NV
Phone: +32 15 342 900
EMail: medicalinfo@glpg.com
Publications:
Strambu IR, Fagard L, Ford P, Van Der Aa T, De Haas-Amatsaleh A, Santermans E, Seemayer C. (2020). Idiopathic pulmonary fibrosis (IPF): observations from a Phase 2 trial of GLPG1205 (PINTA). Abstract for European Respiratory Society International Congress 7-9 September 2020.
Layout table for additonal information
Responsible Party: Galapagos NV
ClinicalTrials.gov Identifier: NCT03725852    
Other Study ID Numbers: GLPG1205-CL-220
2017-004302-18 ( EudraCT Number )
First Submitted: June 8, 2018
First Posted: October 31, 2018
Results First Submitted: July 14, 2021
Results First Posted: September 14, 2021
Last Update Posted: September 14, 2021