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A Study to Assess Efficacy and Safety of GLPG1972/S201086 in Participants With Knee Osteoarthritis (Roccella)

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ClinicalTrials.gov Identifier: NCT03595618
Recruitment Status : Completed
First Posted : July 23, 2018
Results First Posted : May 12, 2021
Last Update Posted : July 28, 2021
Sponsor:
Collaborator:
Institut de Recherches Internationales Servier
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 Osteoarthritis
Interventions Drug: GLPG1972
Drug: Placebo
Enrollment 932
Recruitment Details The first participant was screened on 14 August 2018. The last study visit occurred on 14 July 2020. Due to the exceptional circumstances in relation to the COVID-19 pandemic, the Sponsor decided in accordance with competent regulatory authorities' guidelines to implement some precautionary measures in order to mitigate the risk of infection.
Pre-assignment Details A total of 3319 participants were screened and 932 participants were randomized and 931 participants were treated.
Arm/Group Title GLPG1972 75 mg GLPG1972 150 mg GLPG1972 300 mg Placebo
Hide Arm/Group Description Participants received 1 film-coated tablet of GLPG1972 75 mg and 3 GLPG1972 matching placebo tablets, orally once daily for 52 weeks. Participants received 2 film-coated tablets of GLPG1972 75 mg (total dose 150 mg) and 2 GLPG1972 matching placebo tablets, orally once daily for 52 weeks. Participants received 4 film-coated tablets of GLPG1972 75 mg (total dose 300 mg), orally once daily for 52 weeks. Participants received 4 film-coated tablets of GLPG1972 matching placebo, orally once daily for 52 weeks.
Period Title: Overall Study
Started 234 231 233 234
Treated [1] 234 231 232 234
Completed 191 191 177 200
Not Completed 43 40 56 34
Reason Not Completed
Adverse Event             16             17             20             8
Withdrawal by Subject             12             14             14             10
Lost to Follow-up             6             4             5             6
Protocol Violation             2             0             6             2
Physician Decision             0             0             1             2
Miscellaneous             7             5             10             6
[1]
All participants having taken at least one dose of investigational medicinal product (IMP)
Arm/Group Title GLPG1972 75 mg GLPG1972 150 mg GLPG1972 300 mg Placebo Total
Hide Arm/Group Description Participants received 1 film-coated tablet of GLPG1972 75 mg and 3 GLPG1972 matching placebo tablets, orally once daily for 52 weeks. Participants received 2 film-coated tablets of GLPG1972 75 mg (total dose 150 mg) and 2 GLPG1972 matching placebo tablets, orally once daily for 52 weeks. Participants received 4 film-coated tablets of GLPG1972 75 mg (total dose 300 mg), orally once daily for 52 weeks. Participants received 4 film-coated tablets of GLPG1972 matching placebo, orally once daily for 52 weeks. Total of all reporting groups
Overall Number of Baseline Participants 234 231 233 234 932
Hide Baseline Analysis Population Description
Modified Randomised Set (mRS): All included participants to whom a therapeutic unit was randomly assigned using the interactive web response system.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 234 participants 231 participants 233 participants 234 participants 932 participants
62.9  (7.5) 63.2  (7.2) 62.1  (7.4) 63.3  (7.1) 62.9  (7.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 234 participants 231 participants 233 participants 234 participants 932 participants
Female
164
  70.1%
165
  71.4%
154
  66.1%
163
  69.7%
646
  69.3%
Male
70
  29.9%
66
  28.6%
79
  33.9%
71
  30.3%
286
  30.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 234 participants 231 participants 233 participants 234 participants 932 participants
Hispanic or Latino
52
  22.2%
52
  22.5%
36
  15.5%
53
  22.6%
193
  20.7%
Not Hispanic or Latino
182
  77.8%
179
  77.5%
197
  84.5%
181
  77.4%
739
  79.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 234 participants 231 participants 233 participants 234 participants 932 participants
American Indian or Alaska Native
1
   0.4%
0
   0.0%
2
   0.9%
0
   0.0%
3
   0.3%
Asian
31
  13.2%
28
  12.1%
30
  12.9%
32
  13.7%
121
  13.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   0.4%
0
   0.0%
0
   0.0%
1
   0.1%
Black or African American
27
  11.5%
19
   8.2%
25
  10.7%
25
  10.7%
96
  10.3%
White
167
  71.4%
177
  76.6%
168
  72.1%
171
  73.1%
683
  73.3%
More than one race
8
   3.4%
6
   2.6%
8
   3.4%
6
   2.6%
28
   3.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Cartilage Thickness of the Central Medial Tibiofemoral Compartment (cMTFC) of the Target Knee   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Mm
Number Analyzed 233 participants 229 participants 231 participants 234 participants 927 participants
3.25316  (0.75857) 3.23101  (0.75531) 3.33075  (0.79839) 3.18554  (0.81513) 3.24996  (0.78289)
[1]
Measure Description: Cartilage thickness of the cMTFC of the target knee was measured by quantitative magnetic resonance imaging (qMRI)
[2]
Measure Analysis Population Description: Number of participants analyzed included participants with available data of cartilage thickness in the cMTFC at baseline.
1.Primary Outcome
Title Change From Baseline in Cartilage Thickness of the cMTFC as Assessed by qMRI on the Target Knee to Week 52
Hide Description Reduction in cartilage loss was assessed by cartilage thickness as measured in the medial cMTFC of the target knee using qMRI.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the mRS. Overall number of participants analyzed included participants with available data of cartilage thickness in the cMTFC at baseline and Week 52.
Arm/Group Title GLPG1972 75 mg GLPG1972 150 mg GLPG1972 300 mg Placebo
Hide Arm/Group Description:
Participants received 1 film-coated tablet of GLPG1972 75 mg and 3 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.
Participants received 2 film-coated tablets of GLPG1972 75 mg (total dose 150 mg) and 2 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.
Participants received 4 film-coated tablets of GLPG1972 75 mg (total dose 300 mg), orally once daily for 52 weeks.
Participants received 4 film-coated tablets of GLPG1972 matching placebo, orally once daily for 52 weeks.
Overall Number of Participants Analyzed 162 158 151 172
Mean (Standard Deviation)
Unit of Measure: mm
-0.06791  (0.20169) -0.09693  (0.26839) -0.08545  (0.21697) -0.11562  (0.27275)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GLPG1972 75 mg, Placebo
Comments Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose minus placebo using mixed-effects model for repeated measures (MMRM) including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.165
Comments Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 0.04514
Confidence Interval (2-Sided) 95%
-0.00317 to 0.09345
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.02465
Estimation Comments Two-sided 95% confidence interval of the estimate without Dunnett adjustment.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GLPG1972 150 mg, Placebo
Comments Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose minus placebo using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.939
Comments Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 0.01200
Confidence Interval (2-Sided) 95%
-0.03868 to 0.06267
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.02585
Estimation Comments Two-sided 95% confidence interval of the estimate without Dunnett adjustment.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GLPG1972 300 mg, Placebo
Comments Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose minus placebo using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.682
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 0.02329
Confidence Interval (2-Sided) 95%
-0.02641 to 0.07300
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.02536
Estimation Comments Two-sided 95% confidence interval of the estimate without Dunnett adjustment.
2.Secondary Outcome
Title Number of Participants Who Were Osteoarthritis (OA) Structural Progressors Based on Cartilage Thickness in the cMTFC Assessed by qMRI on the Target Knee
Hide Description A "structural progressor" was defined as a participant who had an 8% cartilage loss in cMTFC. Number of participants who met the criteria of "structural progressor" at Week 52 are provided.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the mRS. Overall number of participants analyzed included participants with available data of cartilage thickness in the cMTFC at Week 52.
Arm/Group Title GLPG1972 75 mg GLPG1972 150 mg GLPG1972 300 mg Placebo
Hide Arm/Group Description:
Participants received 1 film-coated tablet of GLPG1972 75 mg and 3 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.
Participants received 2 film-coated tablets of GLPG1972 75 mg (total dose 150 mg) and 2 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.
Participants received 4 film-coated tablets of GLPG1972 75 mg (total dose 300 mg), orally once daily for 52 weeks.
Participants received 4 film-coated tablets of GLPG1972 matching placebo, orally once daily for 52 weeks.
Overall Number of Participants Analyzed 162 158 151 172
Measure Type: Count of Participants
Unit of Measure: Participants
22
  13.6%
34
  21.5%
25
  16.6%
35
  20.3%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GLPG1972 75 mg, Placebo
Comments Estimate (Standard Error of log [estimate]) of the adjusted odds ratio between GLPG1972 dose regimen and placebo: between the proportions of participants with response: placebo versus GLPG1972 dose regimen
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.396
Comments Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05)
Method Logistic Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.47
Confidence Interval (2-Sided) 95%
0.84 to 2.58
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.29
Estimation Comments Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GLPG1972 150 mg, Placebo
Comments Estimate (Standard Error of log [estimate]) of the adjusted odds ratio between GLPG1972 dose regimen and placebo: between the proportions of participants with response: placebo versus GLPG1972 dose regimen
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.951
Comments Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05)
Method Logistic Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.89
Confidence Interval (2-Sided) 95%
0.53 to 1.50
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.26
Estimation Comments Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GLPG1972 300 mg, Placebo
Comments Estimate (Standard Error of log [estimate]) of the adjusted odds ratio between GLPG1972 dose regimen and placebo: between the proportions of participants with response: placebo versus GLPG1972 dose regimen
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.985
Comments Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05)
Method Logistic Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.08
Confidence Interval (2-Sided) 95%
0.64 to 1.83
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.27
Estimation Comments Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment
3.Secondary Outcome
Title Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score and Subscales Scores for Pain, Function, and Stiffness to Week 52
Hide Description Western Ontario and McMaster Universities Osteoarthritis Index is a questionnaire designed to assess health status and health outcomes in participants with OA of the knee. The questionnaire contains 24 questions targeting areas of pain, stiffness, and physical function. Pain subscale includes 5 items rated on a Likert scale of 0 (none) to 4 (extreme) with a total range of 0-20 with higher scores indicating worse symptoms and function. Stiffness subscale includes 2 items rated on a Likert scale of 0 (none) to 4 (extreme) with a total range of 0-8 with higher scores indicating worse symptoms and function. Physical function subscale includes 17 items rated on a Likert scale of 0 (none) to 4 (extreme) with a total range of 0-68 with higher scores indicating worse symptoms and function. The total score is the sum of all subscales (range: 0 to 96) with higher scores indicating worse symptoms and function.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on mRS. Overall number of participants analyzed included participants with available data of WOMAC score at baseline. Number of participants analyzed for change from baseline to Week 52 included participants with available data of WOMAC score at baseline and Week 52.
Arm/Group Title GLPG1972 75 mg GLPG1972 150 mg GLPG1972 300 mg Placebo
Hide Arm/Group Description:
Participants received 1 film-coated tablet of GLPG1972 75 mg and 3 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.
Participants received 2 film-coated tablets of GLPG1972 75 mg (total dose 150 mg) and 2 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.
Participants received 4 film-coated tablets of GLPG1972 75 mg (total dose 300 mg), orally once daily for 52 weeks.
Participants received 4 film-coated tablets of GLPG1972 matching placebo, orally once daily for 52 weeks.
Overall Number of Participants Analyzed 233 230 231 234
Mean (Standard Deviation)
Unit of Measure: score on a scale
Total score: Baseline Number Analyzed 233 participants 230 participants 231 participants 234 participants
48.0  (15.2) 48.7  (15.0) 47.0  (15.2) 48.3  (14.5)
Total score: Change from baseline to Week 52 Number Analyzed 189 participants 187 participants 176 participants 200 participants
-16.3  (17.7) -16.9  (17.7) -16.1  (19.8) -18.4  (18.9)
Pain subscore: Baseline Number Analyzed 233 participants 230 participants 231 participants 234 participants
10.2  (3.2) 10.0  (3.1) 9.8  (3.1) 10.0  (3.2)
Pain subscore: Change from baseline to Week 52 Number Analyzed 189 participants 187 participants 176 participants 200 participants
-3.9  (4.1) -3.7  (4.0) -3.7  (4.2) -4.1  (4.1)
Physical function subscore: Baseline Number Analyzed 233 participants 230 participants 231 participants 234 participants
33.8  (11.2) 34.3  (11.2) 33.0  (11.6) 34.1  (10.7)
Physical function subscore: Change from baseline to Week 52 Number Analyzed 189 participants 187 participants 176 participants 200 participants
-11.2  (12.7) -11.9  (13.0) -10.9  (14.7) -12.7  (13.9)
Stiffness subscore: Baseline Number Analyzed 233 participants 230 participants 231 participants 234 participants
4.0  (1.7) 4.3  (1.7) 4.2  (1.6) 4.2  (1.6)
Stiffness subscore: Change from baseline to Week 52 Number Analyzed 189 participants 187 participants 176 participants 200 participants
-1.2  (2.1) -1.3  (2.0) -1.4  (2.0) -1.5  (2.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GLPG1972 75 mg, Placebo
Comments Total score: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.467
Comments Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -2.1
Confidence Interval (2-Sided) 95%
-5.6 to 1.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.7
Estimation Comments Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GLPG1972 150 mg, Placebo
Comments Total score: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.557
Comments Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05)
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -1.9
Confidence Interval (2-Sided) 95%
-5.4 to 1.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.8
Estimation Comments Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GLPG1972 300 mg, Placebo
Comments Total score: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.593
Comments Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -1.9
Confidence Interval (2-Sided) 95%
-5.3 to 1.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.8
Estimation Comments Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection GLPG1972 75 mg, Placebo
Comments Pain subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.776
Comments Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-1.0 to 0.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.4
Estimation Comments Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection GLPG1972 150 mg, Placebo
Comments Pain subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.446
Comments Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.5
Confidence Interval (2-Sided) 95%
-1.2 to 0.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.4
Estimation Comments Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection GLPG1972 300 mg, Placebo
Comments Pain subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.649
Comments Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-1.1 to 0.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.4
Estimation Comments Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection GLPG1972 75 mg, Placebo
Comments Physical function subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.452
Comments Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -1.6
Confidence Interval (2-Sided) 95%
-4.1 to 0.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.3
Estimation Comments Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection GLPG1972 150 mg, Placebo
Comments Physical Function subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.665
Comments Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -1.2
Confidence Interval (2-Sided) 95%
-3.7 to 1.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.3
Estimation Comments Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection GLPG1972 300 mg, Placebo
Comments Physical Function subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.598
Comments Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -1.3
Confidence Interval (2-Sided) 95%
-3.9 to 1.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.3
Estimation Comments Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection GLPG1972 75 mg, Placebo
Comments Stiffness subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.400
Comments Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05)
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-0.6 to 0.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.2
Estimation Comments Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection GLPG1972 150 mg, Placebo
Comments Stiffness subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.393
Comments Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05)
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-0.6 to 0.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.2
Estimation Comments Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection GLPG1972 300 mg, Placebo
Comments Stiffness subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.858
Comments Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05)
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.5 to 0.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.2
Estimation Comments Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment
4.Secondary Outcome
Title Change From Baseline in Pain Assessment in the Target Knee as Measured by Visual Analog Scale (VAS) to Week 52
Hide Description The participant was asked "how would you rate the pain felt in the selected knee within the last 48 hours?". The participants rated the pain by marking the level of pain on a 100-mm VAS, with 0 being no pain and 100 being extreme pain. Higher score indicated higher pain intensity.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on mRS. Overall number of participants analyzed included participants with available data of VAS at baseline. Number of participants analyzed for change from baseline to Week 52 included participants with available data of VAS at baseline and Week 52.
Arm/Group Title GLPG1972 75 mg GLPG1972 150 mg GLPG1972 300 mg Placebo
Hide Arm/Group Description:
Participants received 1 film-coated tablet of GLPG1972 75 mg and 3 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.
Participants received 2 film-coated tablets of GLPG1972 75 mg (total dose 150 mg) and 2 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.
Participants received 4 film-coated tablets of GLPG1972 75 mg (total dose 300 mg), orally once daily for 52 weeks.
Participants received 4 film-coated tablets of GLPG1972 matching placebo, orally once daily for 52 weeks.
Overall Number of Participants Analyzed 234 231 233 234
Mean (Standard Deviation)
Unit of Measure: mm
Baseline Number Analyzed 234 participants 231 participants 233 participants 234 participants
63.3  (11.4) 63.8  (11.5) 63.3  (12.1) 63.5  (11.0)
Change from baseline to Week 52 Number Analyzed 191 participants 185 participants 178 participants 199 participants
-27.2  (24.3) -25.6  (26.9) -28.2  (27.1) -28.9  (25.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GLPG1972 75 mg, Placebo
Comments Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.705
Comments Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -2.2
Confidence Interval (2-Sided) 95%
-7.1 to 2.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.5
Estimation Comments Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GLPG1972 150 mg, Placebo
Comments Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.243
Comments Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -4.1
Confidence Interval (2-Sided) 95%
-9.0 to 0.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.5
Estimation Comments Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GLPG1972 300 mg, Placebo
Comments Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.949
Comments Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -1.1
Confidence Interval (2-Sided) 95%
-6.1 to 3.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.5
Estimation Comments Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.
5.Secondary Outcome
Title Change From Baseline in Patient Global Assessment (PGA) of Disease Activity as Measured by VAS to Week 52
Hide Description The participant was asked "Considering all the ways in which your knee osteoarthritis affects you, please rate on this 100 mm scale how well you are doing today". The participants rated the disease activity by marking on a 100-mm VAS, with 0 being no pain and 100 being extreme pain. Higher score indicated higher disease activity.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on mRS. Overall number of participants analyzed included participants with available data of PGA score at baseline. Number of participants analyzed for change from baseline to Week 52 included participants with available data of PGA score at baseline and Week 52.
Arm/Group Title GLPG1972 75 mg GLPG1972 150 mg GLPG1972 300 mg Placebo
Hide Arm/Group Description:
Participants received 1 film-coated tablet of GLPG1972 75 mg and 3 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.
Participants received 2 film-coated tablets of GLPG1972 75 mg (total dose 150 mg) and 2 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.
Participants received 4 film-coated tablets of GLPG1972 75 mg (total dose 300 mg), orally once daily for 52 weeks.
Participants received 4 film-coated tablets of GLPG1972 matching placebo, orally once daily for 52 weeks.
Overall Number of Participants Analyzed 232 230 232 233
Mean (Standard Deviation)
Unit of Measure: mm
Baseline Number Analyzed 232 participants 230 participants 232 participants 233 participants
47.1  (18.3) 47.9  (19.0) 49.4  (17.5) 50.4  (19.2)
Change from baseline to Week 52 Number Analyzed 191 participants 187 participants 178 participants 200 participants
19.4  (30.0) 14.3  (30.7) 14.1  (28.4) 14.0  (31.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GLPG1972 75 mg, Placebo
Comments Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose regimen minus placebo using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.890
Comments Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 1.4
Confidence Interval (2-Sided) 95%
-3.4 to 6.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.5
Estimation Comments Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GLPG1972 150 mg, Placebo
Comments Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose regimen minus placebo using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.682
Comments Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -2.3
Confidence Interval (2-Sided) 95%
-7.1 to 2.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.5
Estimation Comments Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GLPG1972 300 mg, Placebo
Comments Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose regimen minus placebo using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-4.8 to 5.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.5
Estimation Comments Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.
6.Secondary Outcome
Title Number of Participants Who Were Responders Based on the Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Criteria
Hide Description

OMERACT-OARSI criteria involves improvement based on WOMAC pain and function subscales and PGA. The responders according to OMERACT-OARSI criteria were participants who had:

  • A high improvement in pain or in function ≥ 50% and absolute change ≥ 20, OR
  • Improvement in at least 2 of the 3 following:

    • Pain ≥ 20% and absolute change ≥ 10
    • Function ≥ 20% and absolute change ≥ 10
    • Patient's global assessment ≥ 20% and absolute change ≥ 10.

WOMAC pain subscale score: range of 0 to 20, higher scores indicating more pain,

WOMAC physical function subscale score: range of 0 to 68, higher scores indicating worse physical function),

PGA: The participant was asked "Considering all the ways in which your knee osteoarthritis affects you, please rate on this 100 mm scale how well you are doing today". The participants rated disease activity by marking on a 100-mm VAS, with 0 being no pain and 100 being extreme pain. Higher score indicated higher disease activity.

Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the mRS. Overall number of participants analyzed included participants with available data of WOMAC pain and function subscales and PGA at Week 52.
Arm/Group Title GLPG1972 75 mg GLPG1972 150 mg GLPG1972 300 mg Placebo
Hide Arm/Group Description:
Participants received 1 film-coated tablet of GLPG1972 75 mg and 3 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.
Participants received 2 film-coated tablets of GLPG1972 75 mg (total dose 150 mg) and 2 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.
Participants received 4 film-coated tablets of GLPG1972 75 mg (total dose 300 mg), orally once daily for 52 weeks.
Participants received 4 film-coated tablets of GLPG1972 matching placebo, orally once daily for 52 weeks.
Overall Number of Participants Analyzed 189 187 176 200
Measure Type: Count of Participants
Unit of Measure: Participants
125
  66.1%
119
  63.6%
103
  58.5%
127
  63.5%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GLPG1972 75 mg, Placebo
Comments Estimate (Standard Error of log [estimate]) of the adjusted odds ratio between GLPG1972 dose regimen and placebo: between the proportions of participants with response: placebo versus GLPG1972 dose regimen.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.991
Comments Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).
Method Logistic Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.05
Confidence Interval (2-Sided) 95%
0.70 to 1.58
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.21
Estimation Comments Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GLPG1972 150 mg, Placebo
Comments Estimate (Standard Error of log [estimate]) of the adjusted odds ratio between GLPG1972 dose regimen and placebo: between the proportions of participants with response: placebo versus GLPG1972 dose regimen.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.992
Comments Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).
Method Logistic Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.95
Confidence Interval (2-Sided) 95%
0.64 to 1.43
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.21
Estimation Comments Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GLPG1972 300 mg, Placebo
Comments Estimate (Standard Error of log [estimate]) of the adjusted odds ratio between GLPG1972 dose regimen and placebo: between the proportions of participants with response: placebo versus GLPG1972 dose regimen.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.653
Comments Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).
Method Logistic Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.82
Confidence Interval (2-Sided) 95%
0.55 to 1.23
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.21
Estimation Comments Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.
7.Secondary Outcome
Title Change From Baseline in Cartilage Thickness of the Total Tibiofemoral Compartment (tTFC) of the Target Knee by qMRI to Week 52
Hide Description Reduction of cartilage loss was measured by cartilage thickness of the tTFC of the target knee using qMRI.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on mRS. Overall number of participants analyzed included participants with available data of cartilage thickness of the tTFC of the target knee at baseline. Number of participants analyzed for change from baseline to Week 52 included participants with available data of cartilage thickness of the tTFC of the target knee at baseline and Week 52.
Arm/Group Title GLPG1972 75 mg GLPG1972 150 mg GLPG1972 300 mg Placebo
Hide Arm/Group Description:
Participants received 1 film-coated tablet of GLPG1972 75 mg and 3 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.
Participants received 2 film-coated tablets of GLPG1972 75 mg (total dose 150 mg) and 2 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.
Participants received 4 film-coated tablets of GLPG1972 75 mg (total dose 300 mg), orally once daily for 52 weeks.
Participants received 4 film-coated tablets of GLPG1972 matching placebo, orally once daily for 52 weeks.
Overall Number of Participants Analyzed 232 229 231 234
Mean (Standard Deviation)
Unit of Measure: mm
Baseline Number Analyzed 232 participants 229 participants 231 participants 234 participants
6.49218  (1.02749) 6.57424  (1.02706) 6.51256  (0.97704) 6.45879  (1.01774)
Change from baseline to Week 52 Number Analyzed 162 participants 158 participants 150 participants 172 participants
-0.03572  (0.17673) -0.02401  (0.20766) -0.01678  (0.20934) -0.06447  (0.23480)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GLPG1972 75 mg, Placebo
Comments Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.193
Comments Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 0.03779
Confidence Interval (2-Sided) 95%
-0.00448 to 0.08005
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.02156
Estimation Comments Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GLPG1972 150 mg, Placebo
Comments Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.256
Comments Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 0.03580
Confidence Interval (2-Sided) 95%
-0.00801 to 0.07962
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.02235
Estimation Comments Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GLPG1972 300 mg, Placebo
Comments Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.201
Comments Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 0.03884
Confidence Interval (2-Sided) 95%
-0.00514 to 0.08281
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.02243
Estimation Comments Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.
8.Secondary Outcome
Title Change From Baseline in Bone Area of the Medial Femoral Condyle Surface of the Target Knee by qMRI to Week 28
Hide Description [Not Specified]
Time Frame Baseline, Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on mRS. Overall number of participants analyzed included participants with available data of bone area of the medial femoral condyle surface of the target knee at baseline. Number of participants analyzed for change from baseline to Week 28 included participants with available data of bone area of the medial femoral condyle surface of the target knee at baseline and Week 28.
Arm/Group Title GLPG1972 75 mg GLPG1972 150 mg GLPG1972 300 mg Placebo
Hide Arm/Group Description:
Participants received 1 film-coated tablet of GLPG1972 75 mg and 3 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.
Participants received 2 film-coated tablets of GLPG1972 75 mg (total dose 150 mg) and 2 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.
Participants received 4 film-coated tablets of GLPG1972 75 mg (total dose 300 mg), orally once daily for 52 weeks.
Participants received 4 film-coated tablets of GLPG1972 matching placebo, orally once daily for 52 weeks.
Overall Number of Participants Analyzed 234 229 232 234
Mean (Standard Deviation)
Unit of Measure: mm^2
Baseline Number Analyzed 234 participants 229 participants 232 participants 234 participants
2343.32026  (371.23246) 2346.17547  (373.46086) 2354.77368  (385.91599) 2333.67525  (362.46041)
Change from baseline to Week 28 Number Analyzed 202 participants 191 participants 190 participants 210 participants
8.21893  (31.81812) 11.11178  (33.14557) 7.63991  (33.60899) 11.43549  (29.60810)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GLPG1972 75 mg, Placebo
Comments Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: Placebo minus GLPG1972 dose regimen using an analysis of covariance (ANCOVA) including the factors treatment and region with baseline as covariate and no interaction, after a Multiple Imputation for missing data.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.627
Comments Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 3.12394
Confidence Interval (2-Sided) 95%
-3.02464 to 9.27252
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.13671
Estimation Comments Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GLPG1972 150 mg, Placebo
Comments Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: Placebo minus GLPG1972 dose regimen using an ANCOVA including the factors treatment and region with baseline as covariate and no interaction, after a Multiple Imputation for missing data.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.998
Comments Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 0.46842
Confidence Interval (2-Sided) 95%
-5.82659 to 6.76343
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.21111
Estimation Comments Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GLPG1972 300 mg, Placebo
Comments Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: Placebo minus GLPG1972 dose regimen using an ANCOVA including the factors treatment and region with baseline as covariate and no interaction, after a Multiple Imputation for missing data.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.449
Comments Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 4.11756
Confidence Interval (2-Sided) 95%
-2.30536 to 10.54049
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.27590
Estimation Comments Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.
9.Secondary Outcome
Title Change From Baseline in Bone Area of the Medial Femoral Condyle Surface of the Target Knee by qMRI to Week 52
Hide Description [Not Specified]
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on mRS. Overall number of participants analyzed included participants with available data of bone area of the medial femoral condyle surface of the target knee at baseline. Number of participants analyzed for change from baseline to Week 52 included participants with available data of bone area of the medial femoral condyle surface of the target knee at baseline and Week 52.
Arm/Group Title GLPG1972 75 mg GLPG1972 150 mg GLPG1972 300 mg Placebo
Hide Arm/Group Description:
Participants received 1 film-coated tablet of GLPG1972 75 mg and 3 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.
Participants received 2 film-coated tablets of GLPG1972 75 mg (total dose 150 mg) and 2 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.
Participants received 4 film-coated tablets of GLPG1972 75 mg (total dose 300 mg), orally once daily for 52 weeks.
Participants received 4 film-coated tablets of GLPG1972 matching placebo, orally once daily for 52 weeks.
Overall Number of Participants Analyzed 234 229 232 234
Mean (Standard Deviation)
Unit of Measure: mm^2
Baseline Number Analyzed 234 participants 229 participants 232 participants 234 participants
2343.32026  (371.23246) 2346.17547  (373.46086) 2354.77368  (385.91599) 2333.67525  (362.46041)
Change from baseline to Week 52 Number Analyzed 162 participants 160 participants 154 participants 172 participants
15.45592  (31.22629) 22.06801  (42.85848) 20.78279  (34.96462) 18.08990  (35.93650)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GLPG1972 75 mg, Placebo
Comments Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.789
Comments Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05)
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 2.84781
Confidence Interval (2-Sided) 95%
-4.51643 to 10.21205
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.75674
Estimation Comments Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GLPG1972 150 mg, Placebo
Comments Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.661
Comments Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -3.64759
Confidence Interval (2-Sided) 95%
-11.19071 to 3.89553
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.84747
Estimation Comments Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GLPG1972 300 mg, Placebo
Comments Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.843
Comments Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -2.55176
Confidence Interval (2-Sided) 95%
-10.04053 to 4.93701
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.81987
Estimation Comments Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.
10.Secondary Outcome
Title Change From Baseline in Joint Space Width (JSW) of the Target Knee to Week 52
Hide Description The JSW is the space measured between the 2 bones in the knee joint and this is assessed by x-ray.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on mRS. Overall number of participants analyzed included participants with available data of JSW at baseline. Number of participants analyzed for change from baseline to Week 52 included participants with available data of JSW at baseline and Week 52.
Arm/Group Title GLPG1972 75 mg GLPG1972 150 mg GLPG1972 300 mg Placebo
Hide Arm/Group Description:
Participants received 1 film-coated tablet of GLPG1972 75 mg and 3 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.
Participants received 2 film-coated tablets of GLPG1972 75 mg (total dose 150 mg) and 2 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.
Participants received 4 film-coated tablets of GLPG1972 75 mg (total dose 300 mg), orally once daily for 52 weeks.
Participants received 4 film-coated tablets of GLPG1972 matching placebo, orally once daily for 52 weeks.
Overall Number of Participants Analyzed 234 230 232 233
Mean (Standard Deviation)
Unit of Measure: mm
Baseline Number Analyzed 234 participants 230 participants 232 participants 233 participants
2.504  (0.779) 2.500  (0.783) 2.577  (0.840) 2.483  (0.859)
Change from baseline to Week 52 Number Analyzed 169 participants 163 participants 155 participants 179 participants
-0.087  (0.397) -0.167  (0.506) -0.113  (0.464) -0.174  (0.470)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GLPG1972 75 mg, Placebo
Comments Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose regimen minus placebo using an ANCOVA including the factors treatment and region with baseline as covariate and no interaction, after a Multiple Imputation for missing data.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.141
Comments Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 0.0951
Confidence Interval (2-Sided) 95%
-0.0028 to 0.1929
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0499
Estimation Comments Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GLPG1972 150 mg, Placebo
Comments Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose regimen minus placebo using an ANCOVA including the factors treatment and region with baseline as covariate and no interaction, after a Multiple Imputation for missing data.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.981
Comments Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 0.0158
Confidence Interval (2-Sided) 95%
-0.0861 to 0.1177
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0519
Estimation Comments Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GLPG1972 300 mg, Placebo
Comments Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose regimen minus placebo using an ANCOVA including the factors treatment and region with baseline as covariate and no interaction, after a Multiple Imputation for missing data.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.349
Comments Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 0.0753
Confidence Interval (2-Sided) 95%
-0.0286 to 0.1792
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0529
Estimation Comments Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.
11.Secondary Outcome
Title Number of Participants Who Have Used at Least 1 Systemic Analgesic During the Study
Hide Description Systemic analgesics included anti-inflammatory and anti-rheumatic products; analgesics; anti-diarrheals, intestinal, anti-inflammatory/anti-infective agents; and drugs for functional gastrointestinal disorders.
Time Frame Baseline up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on mRS.
Arm/Group Title GLPG1972 75 mg GLPG1972 150 mg GLPG1972 300 mg Placebo
Hide Arm/Group Description:
Participants received 1 film-coated tablet of GLPG1972 75 mg and 3 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.
Participants received 2 film-coated tablets of GLPG1972 75 mg (total dose 150 mg) and 2 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.
Participants received 4 film-coated tablets of GLPG1972 75 mg (total dose 300 mg), orally once daily for 52 weeks.
Participants received 4 film-coated tablets of GLPG1972 matching placebo, orally once daily for 52 weeks.
Overall Number of Participants Analyzed 234 231 233 234
Measure Type: Count of Participants
Unit of Measure: Participants
Participants with at least one treatment
216
  92.3%
213
  92.2%
211
  90.6%
212
  90.6%
Anti-inflammatory and anti-rheumatic products
173
  73.9%
167
  72.3%
180
  77.3%
178
  76.1%
Analgesics
127
  54.3%
135
  58.4%
118
  50.6%
128
  54.7%
Anti-diarrheals, intestinal anti-inflammatory/anti-infective agents
0
   0.0%
1
   0.4%
1
   0.4%
1
   0.4%
Drugs for functional gastrointestinal disorders
1
   0.4%
0
   0.0%
0
   0.0%
0
   0.0%
12.Secondary Outcome
Title Plasma Concentrations of GLPG1972
Hide Description [Not Specified]
Time Frame Pre-dose at Weeks 4, 12, and 52; Pre-dose and one post-dose sample (2-4 hours interval) at Week 28; one post dose sample (interval 4-8 hours) at Week 40
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants included participants with available data for plasma concentrations of GLPG1972. Number of participants analyzed included participants with available data for plasma concentrations of GLPG1972 at individual timepoints. As participants in the placebo arm did not receive GLPG1972, measurement of plasma concentrations of GLPG1972 for placebo arm is not applicable.
Arm/Group Title GLPG1972 75 mg GLPG1972 150 mg GLPG1972 300 mg
Hide Arm/Group Description:
Participants received 1 film-coated tablet of GLPG1972 75 mg and 3 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.
Participants received 2 film-coated tablets of GLPG1972 75 mg (total dose 150 mg) and 2 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.
Participants received 4 film-coated tablets of GLPG1972 75 mg (total dose 300 mg), orally once daily for 52 weeks.
Overall Number of Participants Analyzed 217 210 194
Mean (Standard Deviation)
Unit of Measure: μg/mL
Week 4: Pre-dose Number Analyzed 217 participants 210 participants 194 participants
0.445  (0.319) 1  (0.946) 2.013  (1.468)
Week 12: Pre-dose Number Analyzed 208 participants 203 participants 192 participants
0.474  (0.685) 0.952  (0.794) 1.788  (1.51)
Week 28: Pre-dose Number Analyzed 197 participants 188 participants 178 participants
0.457  (0.409) 0.857  (0.696) 1.714  (1.206)
Week 28: 2-4 hours post-dose Number Analyzed 199 participants 188 participants 182 participants
1.399  (0.668) 2.609  (1.022) 4.764  (1.912)
Week 40: 4-8 hours post-dose Number Analyzed 187 participants 184 participants 176 participants
1.54  (0.678) 3.13  (1.2) 5.664  (2.425)
Week 52: Pre-dose Number Analyzed 159 participants 151 participants 147 participants
0.603  (0.6) 1.12  (1.048) 2.132  (1.597)
13.Secondary Outcome
Title Number of Participants With Treatment-emergent Adverse Event (TEAE)
Hide Description

TEAEs were defined as all adverse events (AEs) that occurred:

  • between first IMP intake date (included) and last visit of participant, or
  • before first IMP intake date and that worsened (in terms of intensity) or became serious according to investigator opinion between first IMP intake date (included) and last visit of participant.

Number of participants with at least 1 TEAE (serious or non-serious) are reported.

Time Frame Baseline up to 2-weeks after last dose of IMP (up to Week 54)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set: All participants having taken at least one dose of IMP.
Arm/Group Title GLPG1972 75 mg GLPG1972 150 mg GLPG1972 300 mg Placebo
Hide Arm/Group Description:
Participants received 1 film-coated tablet of GLPG1972 75 mg and 3 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.
Participants received 2 film-coated tablets of GLPG1972 75 mg (total dose 150 mg) and 2 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.
Participants received 4 film-coated tablets of GLPG1972 75 mg (total dose 300 mg), orally once daily for 52 weeks.
Participants received 4 film-coated tablets of GLPG1972 matching placebo, orally once daily for 52 weeks.
Overall Number of Participants Analyzed 234 231 232 234
Measure Type: Count of Participants
Unit of Measure: Participants
174
  74.4%
177
  76.6%
174
  75.0%
174
  74.4%
Time Frame Baseline up to 2-weeks after last dose of IMP (up to Week 54)
Adverse Event Reporting Description

TEAEs were defined as all AEs that occurred:

  • between first IMP intake date (included) and last visit of participant, or
  • before first IMP intake date and that worsened (in terms of intensity) or became serious according to investigator opinion between first IMP intake date (included) and last visit of participant.

Analysis was based on the safety set. All serious AEs are reported, TEAEs are reported at a threshold of 3%.

 
Arm/Group Title GLPG1972 75 mg GLPG1972 150 mg GLPG1972 300 mg Placebo
Hide Arm/Group Description Participants received 1 film-coated tablet of GLPG1972 75 mg and 3 GLPG1972 matching placebo tablets, orally once daily for 52 weeks. Participants received 2 film-coated tablets of GLPG1972 75 mg (total dose 150 mg) and 2 GLPG1972 matching placebo tablets, orally once daily for 52 weeks. Participants received 4 film-coated tablets of GLPG1972 75 mg (total dose 300 mg), orally once daily for 52 weeks. Participants received 4 film-coated tablets of GLPG1972 matching placebo, orally once daily for 52 weeks.
All-Cause Mortality
GLPG1972 75 mg GLPG1972 150 mg GLPG1972 300 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/234 (0.00%)   1/231 (0.43%)   0/232 (0.00%)   0/234 (0.00%) 
Hide Serious Adverse Events
GLPG1972 75 mg GLPG1972 150 mg GLPG1972 300 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   17/234 (7.26%)   17/231 (7.36%)   18/232 (7.76%)   18/234 (7.69%) 
Cardiac disorders         
Atrial fibrillation  1  1/234 (0.43%)  1/231 (0.43%)  1/232 (0.43%)  0/234 (0.00%) 
Myocarditis  1  0/234 (0.00%)  0/231 (0.00%)  1/232 (0.43%)  0/234 (0.00%) 
Atrial flutter  1  1/234 (0.43%)  1/231 (0.43%)  0/232 (0.00%)  0/234 (0.00%) 
Supraventricular tachycardia  1  1/234 (0.43%)  0/231 (0.00%)  0/232 (0.00%)  0/234 (0.00%) 
Acute myocardial infarction  1  0/234 (0.00%)  0/231 (0.00%)  0/232 (0.00%)  2/234 (0.85%) 
Coronary artery occlusion  1  0/234 (0.00%)  0/231 (0.00%)  0/232 (0.00%)  1/234 (0.43%) 
Coronary artery stenosis  1  0/234 (0.00%)  0/231 (0.00%)  0/232 (0.00%)  1/234 (0.43%) 
Ear and labyrinth disorders         
Vertigo  1  0/234 (0.00%)  1/231 (0.43%)  0/232 (0.00%)  0/234 (0.00%) 
Eye disorders         
Retinal detachment  1  0/234 (0.00%)  0/231 (0.00%)  1/232 (0.43%)  0/234 (0.00%) 
Angle closure glaucoma  1  0/234 (0.00%)  0/231 (0.00%)  0/232 (0.00%)  1/234 (0.43%) 
Macular degeneration  1  0/234 (0.00%)  0/231 (0.00%)  0/232 (0.00%)  1/234 (0.43%) 
Gastrointestinal disorders         
Food poisoning  1  0/234 (0.00%)  0/231 (0.00%)  1/232 (0.43%)  0/234 (0.00%) 
Peritoneal cyst  1  0/234 (0.00%)  1/231 (0.43%)  0/232 (0.00%)  0/234 (0.00%) 
Abdominal incarcerated hernia  1  1/234 (0.43%)  0/231 (0.00%)  0/232 (0.00%)  0/234 (0.00%) 
Intestinal obstruction  1  1/234 (0.43%)  0/231 (0.00%)  0/232 (0.00%)  0/234 (0.00%) 
Nausea  1  1/234 (0.43%)  0/231 (0.00%)  0/232 (0.00%)  0/234 (0.00%) 
General disorders         
Chills  1  1/234 (0.43%)  0/231 (0.00%)  0/232 (0.00%)  0/234 (0.00%) 
Non-cardiac chest pain  1  1/234 (0.43%)  0/231 (0.00%)  0/232 (0.00%)  0/234 (0.00%) 
Hepatobiliary disorders         
Cholelithiasis  1  0/234 (0.00%)  1/231 (0.43%)  0/232 (0.00%)  0/234 (0.00%) 
Cholecystitis acute  1  0/234 (0.00%)  0/231 (0.00%)  0/232 (0.00%)  2/234 (0.85%) 
Bile duct stone  1  0/234 (0.00%)  0/231 (0.00%)  0/232 (0.00%)  1/234 (0.43%) 
Drug-induced liver injury  1  0/234 (0.00%)  0/231 (0.00%)  0/232 (0.00%)  1/234 (0.43%) 
Infections and infestations         
COVID-19  1  0/234 (0.00%)  1/231 (0.43%)  1/232 (0.43%)  0/234 (0.00%) 
Gastroenteritis  1  0/234 (0.00%)  0/231 (0.00%)  1/232 (0.43%)  0/234 (0.00%) 
Pneumonia bacterial  1  0/234 (0.00%)  0/231 (0.00%)  1/232 (0.43%)  0/234 (0.00%) 
Bronchitis  1  0/234 (0.00%)  1/231 (0.43%)  0/232 (0.00%)  0/234 (0.00%) 
Pyelonephritis  1  1/234 (0.43%)  0/231 (0.00%)  0/232 (0.00%)  0/234 (0.00%) 
Urinary tract infection  1  1/234 (0.43%)  0/231 (0.00%)  0/232 (0.00%)  0/234 (0.00%) 
Appendiceal abscess  1  0/234 (0.00%)  0/231 (0.00%)  0/232 (0.00%)  1/234 (0.43%) 
Burn infection  1  0/234 (0.00%)  0/231 (0.00%)  0/232 (0.00%)  1/234 (0.43%) 
Injury, poisoning and procedural complications         
Face injury  1  0/234 (0.00%)  0/231 (0.00%)  1/232 (0.43%)  0/234 (0.00%) 
Procedural pain  1  0/234 (0.00%)  0/231 (0.00%)  1/232 (0.43%)  0/234 (0.00%) 
Tendon rupture  1  0/234 (0.00%)  0/231 (0.00%)  1/232 (0.43%)  0/234 (0.00%) 
Fall  1  1/234 (0.43%)  0/231 (0.00%)  0/232 (0.00%)  0/234 (0.00%) 
Femur fracture  1  1/234 (0.43%)  0/231 (0.00%)  0/232 (0.00%)  0/234 (0.00%) 
Wrist fracture  1  1/234 (0.43%)  0/231 (0.00%)  0/232 (0.00%)  0/234 (0.00%) 
Humerus fracture  1  0/234 (0.00%)  0/231 (0.00%)  0/232 (0.00%)  1/234 (0.43%) 
Joint dislocation  1  0/234 (0.00%)  0/231 (0.00%)  0/232 (0.00%)  1/234 (0.43%) 
Metabolism and nutrition disorders         
Dehydration  1  0/234 (0.00%)  0/231 (0.00%)  1/232 (0.43%)  0/234 (0.00%) 
Hypercalcaemia  1  1/234 (0.43%)  0/231 (0.00%)  0/232 (0.00%)  0/234 (0.00%) 
Musculoskeletal and connective tissue disorders         
Osteoarthritis  1  2/234 (0.85%)  2/231 (0.87%)  3/232 (1.29%)  0/234 (0.00%) 
Arthralgia  1  2/234 (0.85%)  1/231 (0.43%)  1/232 (0.43%)  0/234 (0.00%) 
Back pain  1  0/234 (0.00%)  0/231 (0.00%)  1/232 (0.43%)  0/234 (0.00%) 
Myopathy  1  0/234 (0.00%)  1/231 (0.43%)  0/232 (0.00%)  0/234 (0.00%) 
Joint swelling  1  1/234 (0.43%)  0/231 (0.00%)  0/232 (0.00%)  0/234 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Prostate cancer stage II  1  0/234 (0.00%)  0/231 (0.00%)  1/232 (0.43%)  0/234 (0.00%) 
Invasive ductal breast carcinoma  1  0/234 (0.00%)  3/231 (1.30%)  0/232 (0.00%)  1/234 (0.43%) 
Invasive papillary breast carcinoma  1  0/234 (0.00%)  1/231 (0.43%)  0/232 (0.00%)  0/234 (0.00%) 
Endometrial adenocarcinoma  1  1/234 (0.43%)  0/231 (0.00%)  0/232 (0.00%)  0/234 (0.00%) 
Malignant melanoma in situ  1  1/234 (0.43%)  0/231 (0.00%)  0/232 (0.00%)  0/234 (0.00%) 
Basal cell carcinoma  1  0/234 (0.00%)  0/231 (0.00%)  0/232 (0.00%)  1/234 (0.43%) 
Glottis carcinoma  1  0/234 (0.00%)  0/231 (0.00%)  0/232 (0.00%)  1/234 (0.43%) 
Intraductal proliferative breast lesion  1  0/234 (0.00%)  0/231 (0.00%)  0/232 (0.00%)  1/234 (0.43%) 
Nervous system disorders         
Cervical cord compression  1  0/234 (0.00%)  0/231 (0.00%)  1/232 (0.43%)  0/234 (0.00%) 
Sciatica  1  0/234 (0.00%)  0/231 (0.00%)  1/232 (0.43%)  0/234 (0.00%) 
Ischaemic stroke  1  2/234 (0.85%)  1/231 (0.43%)  0/232 (0.00%)  1/234 (0.43%) 
Cerebrovascular accident  1  0/234 (0.00%)  1/231 (0.43%)  0/232 (0.00%)  0/234 (0.00%) 
Syncope  1  1/234 (0.43%)  0/231 (0.00%)  0/232 (0.00%)  1/234 (0.43%) 
Hypoaesthesia  1  1/234 (0.43%)  0/231 (0.00%)  0/232 (0.00%)  0/234 (0.00%) 
Psychiatric disorders         
Depression suicidal  1  0/234 (0.00%)  0/231 (0.00%)  1/232 (0.43%)  0/234 (0.00%) 
Renal and urinary disorders         
Acute kidney injury  1  1/234 (0.43%)  0/231 (0.00%)  1/232 (0.43%)  0/234 (0.00%) 
Ureterolithiasis  1  1/234 (0.43%)  0/231 (0.00%)  0/232 (0.00%)  0/234 (0.00%) 
Reproductive system and breast disorders         
Ovarian cyst  1  0/234 (0.00%)  1/231 (0.43%)  0/232 (0.00%)  0/234 (0.00%) 
Vaginal haemorrhage  1  1/234 (0.43%)  0/231 (0.00%)  0/232 (0.00%)  0/234 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Pulmonary embolism  1  0/234 (0.00%)  0/231 (0.00%)  1/232 (0.43%)  0/234 (0.00%) 
Vascular disorders         
Hypotension  1  0/234 (0.00%)  0/231 (0.00%)  1/232 (0.43%)  1/234 (0.43%) 
Orthostatic hypotension  1  0/234 (0.00%)  0/231 (0.00%)  0/232 (0.00%)  1/234 (0.43%) 
1
Term from vocabulary, MedDRA (23.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
GLPG1972 75 mg GLPG1972 150 mg GLPG1972 300 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   114/234 (48.72%)   124/231 (53.68%)   105/232 (45.26%)   130/234 (55.56%) 
Gastrointestinal disorders         
Nausea  1  3/234 (1.28%)  7/231 (3.03%)  11/232 (4.74%)  5/234 (2.14%) 
Diarrhoea  1  3/234 (1.28%)  7/231 (3.03%)  4/232 (1.72%)  7/234 (2.99%) 
General disorders         
Oedema peripheral  1  6/234 (2.56%)  4/231 (1.73%)  2/232 (0.86%)  8/234 (3.42%) 
Infections and infestations         
Nasopharyngitis  1  21/234 (8.97%)  16/231 (6.93%)  22/232 (9.48%)  20/234 (8.55%) 
Upper respiratory tract infection  1  7/234 (2.99%)  12/231 (5.19%)  6/232 (2.59%)  10/234 (4.27%) 
Bronchitis  1  8/234 (3.42%)  7/231 (3.03%)  5/232 (2.16%)  6/234 (2.56%) 
Urinary tract infection  1  6/234 (2.56%)  5/231 (2.16%)  4/232 (1.72%)  8/234 (3.42%) 
Influenza  1  8/234 (3.42%)  4/231 (1.73%)  3/232 (1.29%)  7/234 (2.99%) 
Injury, poisoning and procedural complications         
Fall  1  14/234 (5.98%)  20/231 (8.66%)  16/232 (6.90%)  13/234 (5.56%) 
Contusion  1  4/234 (1.71%)  7/231 (3.03%)  6/232 (2.59%)  6/234 (2.56%) 
Investigations         
Gamma-glutamyltransferase increased  1  3/234 (1.28%)  2/231 (0.87%)  16/232 (6.90%)  4/234 (1.71%) 
Blood creatine phosphokinase increased  1  12/234 (5.13%)  7/231 (3.03%)  9/232 (3.88%)  8/234 (3.42%) 
Alanine aminotransferase increased  1  4/234 (1.71%)  3/231 (1.30%)  10/232 (4.31%)  7/234 (2.99%) 
Aspartate aminotransferase increased  1  4/234 (1.71%)  2/231 (0.87%)  10/232 (4.31%)  6/234 (2.56%) 
C-reactive protein increased  1  1/234 (0.43%)  1/231 (0.43%)  9/232 (3.88%)  2/234 (0.85%) 
Metabolism and nutrition disorders         
Hypercholesterolaemia  1  3/234 (1.28%)  7/231 (3.03%)  4/232 (1.72%)  7/234 (2.99%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  26/234 (11.11%)  34/231 (14.72%)  26/232 (11.21%)  19/234 (8.12%) 
Back pain  1  11/234 (4.70%)  10/231 (4.33%)  6/232 (2.59%)  19/234 (8.12%) 
Osteoarthritis  1  6/234 (2.56%)  10/231 (4.33%)  8/232 (3.45%)  10/234 (4.27%) 
Pain in extremity  1  5/234 (2.14%)  7/231 (3.03%)  6/232 (2.59%)  4/234 (1.71%) 
Musculoskeletal pain  1  3/234 (1.28%)  4/231 (1.73%)  8/232 (3.45%)  5/234 (2.14%) 
Joint swelling  1  3/234 (1.28%)  7/231 (3.03%)  4/232 (1.72%)  4/234 (1.71%) 
Nervous system disorders         
Headache  1  15/234 (6.41%)  12/231 (5.19%)  11/232 (4.74%)  9/234 (3.85%) 
Vascular disorders         
Hypertension  1  6/234 (2.56%)  9/231 (3.90%)  12/232 (5.17%)  16/234 (6.84%) 
1
Term from vocabulary, MedDRA (23.0)
Indicates events were collected by systematic assessment
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 15342900
EMail: medicalinfo@glpg.com
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Responsible Party: Galapagos NV
ClinicalTrials.gov Identifier: NCT03595618    
Other Study ID Numbers: GLPG1972-CL-201
2017-004581-10 ( EudraCT Number )
U1111-1205-0321 ( Other Identifier: Universal Trial Number )
First Submitted: July 11, 2018
First Posted: July 23, 2018
Results First Submitted: April 20, 2021
Results First Posted: May 12, 2021
Last Update Posted: July 28, 2021