Trial · NCT03595618
A Study to Assess Efficacy and Safety of GLPG1972/S201086 in Participants With Knee Osteoarthritis
NCT03595618, Phase 2, Completed, Lakefront Biotherapeutics NV; results first posted 2021-05-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Assess Efficacy and Safety of GLPG1972/S201086 in Participants With Knee Osteoarthritis. Trials, record NCT03595618. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03595618
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Assess Efficacy and Safety of GLPG1972/S201086 in Participants With Knee Osteoarthritis
- NCT number
- NCT03595618
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 932 participants, actual
- Lead sponsor
- Lakefront Biotherapeutics NV
- Conditions
- Osteoarthritis
- Interventions
- GLPG1972, Placebo
- First posted
- 2018-07-23
- Last updated
- 2021-07-28
- Other registries' IDs
- eudract:2017-004581-10
- Results first posted
- 2021-05-12
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Cartilage Thickness of the cMTFC as Assessed by qMRI on the Target Knee to Week 52 | Baseline, Week 52 | Reduction in cartilage loss was assessed by cartilage thickness as measured in the medial cMTFC of the target knee using qMRI. |
| Secondary | Number of Participants Who Were Osteoarthritis (OA) Structural Progressors Based on Cartilage Thickness in the cMTFC Assessed by qMRI on the Target Knee | Week 52 | 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. |
| Secondary | 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 | Baseline, Week 52 | 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. |
| Secondary | Change From Baseline in Pain Assessment in the Target Knee as Measured by Visual Analog Scale (VAS) to Week 52 | Baseline, Week 52 | 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. |
| Secondary | Change From Baseline in Patient Global Assessment (PGA) of Disease Activity as Measured by VAS to Week 52 | Baseline, Week 52 | 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. |
| Secondary | Number of Participants Who Were Responders Based on the Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Criteria | Week 52 | 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. |
| Secondary | Change From Baseline in Cartilage Thickness of the Total Tibiofemoral Compartment (tTFC) of the Target Knee by qMRI to Week 52 | Baseline, Week 52 | Reduction of cartilage loss was measured by cartilage thickness of the tTFC of the target knee using qMRI. |
| Secondary | Change From Baseline in Bone Area of the Medial Femoral Condyle Surface of the Target Knee by qMRI to Week 28 | Baseline, Week 28 | |
| Secondary | Change From Baseline in Bone Area of the Medial Femoral Condyle Surface of the Target Knee by qMRI to Week 52 | Baseline, Week 52 | |
| Secondary | Change From Baseline in Joint Space Width (JSW) of the Target Knee to Week 52 | Baseline, Week 52 | The JSW is the space measured between the 2 bones in the knee joint and this is assessed by x-ray. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Cartilage Thickness of the cMTFC as Assessed by qMRI on the Target Knee to Week 52 | Baseline, Week 52 | 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. | mm | MEAN |
| SECONDARY | Number of Participants Who Were Osteoarthritis (OA) Structural Progressors Based on Cartilage Thickness in the cMTFC Assessed by qMRI on the Target Knee | Week 52 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 | Baseline, Week 52 | 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. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Pain Assessment in the Target Knee as Measured by Visual Analog Scale (VAS) to Week 52 | Baseline, Week 52 | 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. | mm | MEAN |
| SECONDARY | Change From Baseline in Patient Global Assessment (PGA) of Disease Activity as Measured by VAS to Week 52 | Baseline, Week 52 | 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. | mm | MEAN |
| SECONDARY | Number of Participants Who Were Responders Based on the Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Criteria | Week 52 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Cartilage Thickness of the Total Tibiofemoral Compartment (tTFC) of the Target Knee by qMRI to Week 52 | Baseline, Week 52 | 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. | mm | MEAN |
| SECONDARY | Change From Baseline in Bone Area of the Medial Femoral Condyle Surface of the Target Knee by qMRI to Week 28 | Baseline, Week 28 | 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. | mm^2 | MEAN |
| SECONDARY | Change From Baseline in Bone Area of the Medial Femoral Condyle Surface of the Target Knee by qMRI to Week 52 | Baseline, Week 52 | 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. | mm^2 | MEAN |
| SECONDARY | Change From Baseline in Joint Space Width (JSW) of the Target Knee to Week 52 | Baseline, Week 52 | 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. | mm | MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group134
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Cartilage Thickness of the cMTFC as Assessed by qMRI on the Target Knee to Week 52 | GLPG1972 75 mg | -0.06791 | Standard Deviation 0.20169 | mm | |
| Change From Baseline in Cartilage Thickness of the cMTFC as Assessed by qMRI on the Target Knee to Week 52 | GLPG1972 150 mg | -0.09693 | Standard Deviation 0.26839 | mm | |
| Change From Baseline in Cartilage Thickness of the cMTFC as Assessed by qMRI on the Target Knee to Week 52 | GLPG1972 300 mg | -0.08545 | Standard Deviation 0.21697 | mm | |
| Change From Baseline in Cartilage Thickness of the cMTFC as Assessed by qMRI on the Target Knee to Week 52 | Placebo | -0.11562 | Standard Deviation 0.27275 | mm | |
| Number of Participants Who Were Osteoarthritis (OA) Structural Progressors Based on Cartilage Thickness in the cMTFC Assessed by qMRI on the Target Knee | GLPG1972 75 mg | 22 | Participants | ||
| Number of Participants Who Were Osteoarthritis (OA) Structural Progressors Based on Cartilage Thickness in the cMTFC Assessed by qMRI on the Target Knee | GLPG1972 150 mg | 34 | Participants | ||
| Number of Participants Who Were Osteoarthritis (OA) Structural Progressors Based on Cartilage Thickness in the cMTFC Assessed by qMRI on the Target Knee | GLPG1972 300 mg | 25 | Participants | ||
| Number of Participants Who Were Osteoarthritis (OA) Structural Progressors Based on Cartilage Thickness in the cMTFC Assessed by qMRI on the Target Knee | Placebo | 35 | Participants | ||
| 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 | GLPG1972 75 mg | Total score: Baseline | 48.0 | Standard Deviation 15.2 | score on a scale |
| 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 | GLPG1972 150 mg | Total score: Baseline | 48.7 | Standard Deviation 15.0 | score on a scale |
1 to 10 of 134Source ClinicalTrials.gov
See all 134 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | GLPG1972 75 mg | 234 | |
| Overall Study | STARTED | GLPG1972 150 mg | 231 | |
| Overall Study | STARTED | GLPG1972 300 mg | 233 | |
| Overall Study | STARTED | Placebo | 234 | |
| Overall Study | Treated | GLPG1972 75 mg | 234 | |
| Overall Study | Treated | GLPG1972 150 mg | 231 | |
| Overall Study | Treated | GLPG1972 300 mg | 232 | |
| Overall Study | Treated | Placebo | 234 | |
| Overall Study | COMPLETED | GLPG1972 75 mg | 191 | |
| Overall Study | COMPLETED | GLPG1972 150 mg | 191 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events364
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Arthralgia | Musculoskeletal and connective tissue disorders | GLPG1972 75 mg | 26 | 234 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | GLPG1972 150 mg | 34 | 231 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | GLPG1972 300 mg | 26 | 232 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Placebo | 19 | 234 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | GLPG1972 75 mg | 11 | 234 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | GLPG1972 150 mg | 10 | 231 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | GLPG1972 300 mg | 6 | 232 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Placebo | 19 | 234 | |
| other | Nasopharyngitis | Infections and infestations | GLPG1972 75 mg | 21 | 234 | |
| other | Nasopharyngitis | Infections and infestations | GLPG1972 150 mg | 16 | 231 |
1 to 10 of 364Source ClinicalTrials.gov
See all 364 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | GLPG1972 75 mg | 0 | 234 |
| Total, all-cause mortality | GLPG1972 150 mg | 1 | 231 |
| Total, all-cause mortality | GLPG1972 300 mg | 0 | 232 |
| Total, all-cause mortality | Placebo | 0 | 234 |
| Total, other adverse events | GLPG1972 75 mg | 114 | 234 |
| Total, other adverse events | GLPG1972 150 mg | 124 | 231 |
| Total, other adverse events | GLPG1972 300 mg | 105 | 232 |
| Total, other adverse events | Placebo | 130 | 234 |
| Total, serious adverse events | GLPG1972 75 mg | 17 | 234 |
| Total, serious adverse events | GLPG1972 150 mg | 17 | 231 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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