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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-004581-10 | EudraCT Number | ||
| U1111-1205-0321 | Other Identifier | Universal Trial Number |
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| Name | Class |
|---|---|
| Institut de Recherches Internationales Servier | OTHER |
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This study is a phase 2, 52-week international, multi-regional, multi-center, randomized, double-blind, placebo-controlled dose-ranging study for the treatment of osteoarthritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLPG1972 75 mg | Experimental | Participants received 1 film-coated tablet of GLPG1972 75 mg and 3 GLPG1972 matching placebo tablets, orally once daily for 52 weeks. |
|
| GLPG1972 150 mg | Experimental | 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. |
|
| GLPG1972 300 mg | Experimental | Participants received 4 film-coated tablets of GLPG1972 75 mg (total dose 300 mg), orally once daily for 52 weeks. |
|
| Placebo | Placebo Comparator | Participants received 4 film-coated tablets of GLPG1972 matching placebo, orally once daily for 52 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLPG1972 | Drug | Film-coated tablets of GLPG1972 for oral use. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Cartilage Thickness of the cMTFC as Assessed by qMRI on the Target Knee to Week 52 | Reduction in cartilage loss was assessed by cartilage thickness as measured in the medial cMTFC of the target knee using qMRI. | Baseline, Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Were Osteoarthritis (OA) Structural Progressors Based on Cartilage Thickness in the cMTFC Assessed by qMRI on the Target Knee | 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. | Week 52 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Galapagos Study Director | Lakefront Biotherapeutics NV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Research Associates, Inc. | Birmingham | Alabama | 35205 | United States | ||
| Achieve Clinical Research, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40826764 | Derived | Chen L, Huang FL, Tang Q, Zhao ZK, Ye ZY, Liang JH. Targeted therapy for knee osteoarthritis: From basic to clinics. Medicine (Baltimore). 2025 Aug 15;104(33):e43686. doi: 10.1097/MD.0000000000043686. | |
| 38862084 | Derived | Larsson S, Lalande A, Stefan Lohmander L, Soret P, Bernard K, Pueyo M, Struglics A. Serum ARGS-aggrecan in a phase 2 clinical trial targeting osteoarthritis. Osteoarthritis Cartilage. 2024 Nov;32(11):1463-1470. doi: 10.1016/j.joca.2024.06.003. Epub 2024 Jun 9. |
Not provided
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A total of 3319 participants were screened and 932 participants were randomized and 931 participants were treated.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | GLPG1972 75 mg | Participants received 1 film-coated tablet of GLPG1972 75 mg and 3 GLPG1972 matching placebo tablets, orally once daily for 52 weeks. |
| FG001 | GLPG1972 150 mg | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 9, 2019 | Apr 13, 2021 |
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| Placebo | Drug | Film-coated tablets of matching placebo for oral use. |
|
| 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 | 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. | Baseline, Week 52 |
| Change From Baseline in Pain Assessment in the Target Knee as Measured by Visual Analog Scale (VAS) to 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. | Baseline, Week 52 |
| Change From Baseline in Patient Global Assessment (PGA) of Disease Activity as Measured by VAS to 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. | Baseline, Week 52 |
| Number of Participants Who Were Responders Based on the Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Criteria | 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:
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. | Week 52 |
| Change From Baseline in Cartilage Thickness of the Total Tibiofemoral Compartment (tTFC) of the Target Knee by qMRI to Week 52 | Reduction of cartilage loss was measured by cartilage thickness of the tTFC of the target knee using qMRI. | Baseline, Week 52 |
| Change From Baseline in Bone Area of the Medial Femoral Condyle Surface of the Target Knee by qMRI to Week 28 | Baseline, Week 28 |
| Change From Baseline in Bone Area of the Medial Femoral Condyle Surface of the Target Knee by qMRI to Week 52 | Baseline, Week 52 |
| Change From Baseline in Joint Space Width (JSW) of the Target Knee to Week 52 | The JSW is the space measured between the 2 bones in the knee joint and this is assessed by x-ray. | Baseline, Week 52 |
| Number of Participants Who Have Used at Least 1 Systemic Analgesic During the Study | Systemic analgesics included anti-inflammatory and anti-rheumatic products; analgesics; anti-diarrheals, intestinal, anti-inflammatory/anti-infective agents; and drugs for functional gastrointestinal disorders. | Baseline up to Week 52 |
| Plasma Concentrations of GLPG1972 | 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 |
| Number of Participants With Treatment-emergent Adverse Event (TEAE) | TEAEs were defined as all adverse events (AEs) that occurred:
Number of participants with at least 1 TEAE (serious or non-serious) are reported. | Baseline up to 2-weeks after last dose of IMP (up to Week 54) |
| Birmingham |
| Alabama |
| 35216 |
| United States |
| Elite Clinical Studies | Phoenix | Arizona | 85018 | United States |
| Hope Research Institute, LLC - Arizona | Phoenix | Arizona | 85018 | United States |
| Arizona Research Center | Phoenix | Arizona | 85053 | United States |
| Clinical Research Consortium Arizona | Tempe | Arizona | 85283 | United States |
| Samy Metyas MD, Inc - Covina Arthritis Clinic | Covina | California | 91723 | United States |
| TriWest Research Associates, LLC | El Cajon | California | 92020 | United States |
| BioSolutions Clinical Research Center | La Mesa | California | 91942 | United States |
| The Helm Center for Pain Management | Laguna Hills | California | 92637 | United States |
| Stanford University | Palo Alto | California | 94304 | United States |
| Artemis Institute for Clinical Research - San Diego | San Diego | California | 92103 | United States |
| Artemis Institute for Clinical Research - San Marcos | San Marcos | California | 92078 | United States |
| Encompass Clinical Research | Spring Valley | California | 91978 | United States |
| Center for Musculoskeletal Care - Yale Medicine | New Haven | Connecticut | 06519 | United States |
| Avail Clinical Research, LLC | DeLand | Florida | 32720 | United States |
| Clinical Physiology Associates Clinical Study Center | Fort Myers | Florida | 33912 | United States |
| Health Awareness, Inc | Jupiter | Florida | 33458 | United States |
| Bioclinica Research | Orlando | Florida | 32806 | United States |
| Stedman Clinical Trials, LLC | Tampa | Florida | 33613 | United States |
| Compass Research, LLC | The Villages | Florida | 32162 | United States |
| Injury Care Research, LLC | Boise | Idaho | 83713 | United States |
| Millennium Pain Center - Bloomington | Bloomington | Illinois | 61704 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Medisphere Medical Research Center | Evansville | Indiana | 47714 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Phoenix Medical Reasearch | Prairie Village | Kansas | 66208 | United States |
| Central Kentucky Research Associates, Inc. | Lexington | Kentucky | 40509 | United States |
| Medpharmics | Metairie | Louisiana | 70006 | United States |
| The Center for Rheumatology and Bone Research | Wheaton | Maryland | 20902 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Clinical Research Consortium Nevada | Las Vegas | Nevada | 89119 | United States |
| NY Scientific | Brooklyn | New York | 11235 | United States |
| Rochester Clinical Research, Inc. | Rochester | New York | 14609 | United States |
| Upstate Clinical Research Associates | Williamsville | New York | 14221 | United States |
| Lillestol Research, LCC | Fargo | North Dakota | 58103 | United States |
| Optimed Research, LTD | Columbus | Ohio | 43235 | United States |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | United States |
| Pioneer Research Solutions Inc. | Houston | Texas | 77099 | United States |
| Diagnostics Research Group | San Antonio | Texas | 78229 | United States |
| Advanced Clinical Research | West Jordan | Utah | 84088 | United States |
| Charlottesville Medical Research Center, LCC | Charlottesville | Virginia | 22911 | United States |
| Health Research of Hampton Roads, Inc. - Newport News | Newport News | Virginia | 23606 | United States |
| Clinical Research Associates of Tidewater | Norfolk | Virginia | 23507 | United States |
| 37059327 | Derived | Schnitzer T, Pueyo M, Deckx H, van der Aar E, Bernard K, Hatch S, van der Stoep M, Grankov S, Phung D, Imbert O, Chimits D, Muller K, Hochberg MC, Bliddal H, Wirth W, Eckstein F, Conaghan PG. Evaluation of S201086/GLPG1972, an ADAMTS-5 inhibitor, for the treatment of knee osteoarthritis in ROCCELLA: a phase 2 randomized clinical trial. Osteoarthritis Cartilage. 2023 Jul;31(7):985-994. doi: 10.1016/j.joca.2023.04.001. Epub 2023 Apr 13. |
| 33719441 | Derived | Brebion F, Gosmini R, Deprez P, Varin M, Peixoto C, Alvey L, Jary H, Bienvenu N, Triballeau N, Blanque R, Cottereaux C, Christophe T, Vandervoort N, Mollat P, Touitou R, Leonard P, De Ceuninck F, Botez I, Monjardet A, van der Aar E, Amantini D. Discovery of GLPG1972/S201086, a Potent, Selective, and Orally Bioavailable ADAMTS-5 Inhibitor for the Treatment of Osteoarthritis. J Med Chem. 2021 Mar 25;64(6):2937-2952. doi: 10.1021/acs.jmedchem.0c02008. Epub 2021 Mar 15. |
| FG002 | GLPG1972 300 mg | Participants received 4 film-coated tablets of GLPG1972 75 mg (total dose 300 mg), orally once daily for 52 weeks. |
| FG003 | Placebo | Participants received 4 film-coated tablets of GLPG1972 matching placebo, orally once daily for 52 weeks. |
| Treated | All participants having taken at least one dose of investigational medicinal product (IMP) |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Modified Randomised Set (mRS): All included participants to whom a therapeutic unit was randomly assigned using the interactive web response system.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | GLPG1972 75 mg | Participants received 1 film-coated tablet of GLPG1972 75 mg and 3 GLPG1972 matching placebo tablets, orally once daily for 52 weeks. |
| BG001 | GLPG1972 150 mg | 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. |
| BG002 | GLPG1972 300 mg | Participants received 4 film-coated tablets of GLPG1972 75 mg (total dose 300 mg), orally once daily for 52 weeks. |
| BG003 | Placebo | Participants received 4 film-coated tablets of GLPG1972 matching placebo, orally once daily for 52 weeks. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Cartilage Thickness of the Central Medial Tibiofemoral Compartment (cMTFC) of the Target Knee | Cartilage thickness of the cMTFC of the target knee was measured by quantitative magnetic resonance imaging (qMRI) | Number of participants analyzed included participants with available data of cartilage thickness in the cMTFC at baseline. | Mean | Standard Deviation | mm |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Cartilage Thickness of the cMTFC as Assessed by qMRI on the Target Knee to Week 52 | Reduction in cartilage loss was assessed by cartilage thickness as measured in the medial cMTFC of the target knee using qMRI. | 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. | Posted | Mean | Standard Deviation | mm | Baseline, Week 52 |
|
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| Secondary | Number of Participants Who Were Osteoarthritis (OA) Structural Progressors Based on Cartilage Thickness in the cMTFC Assessed by qMRI on the Target Knee | 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. | 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. | Posted | Count of Participants | Participants | Week 52 |
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| 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 | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 52 |
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| Secondary | Change From Baseline in Pain Assessment in the Target Knee as Measured by Visual Analog Scale (VAS) to 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. | 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. | Posted | Mean | Standard Deviation | mm | Baseline, Week 52 |
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| Secondary | Change From Baseline in Patient Global Assessment (PGA) of Disease Activity as Measured by VAS to 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. | 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. | Posted | Mean | Standard Deviation | mm | Baseline, Week 52 |
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| Secondary | Number of Participants Who Were Responders Based on the Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Criteria | 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:
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. | 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. | Posted | Count of Participants | Participants | Week 52 |
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| Secondary | Change From Baseline in Cartilage Thickness of the Total Tibiofemoral Compartment (tTFC) of the Target Knee by qMRI to Week 52 | Reduction of cartilage loss was measured by cartilage thickness of the tTFC of the target knee using qMRI. | 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. | Posted | Mean | Standard Deviation | mm | Baseline, Week 52 |
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| Secondary | Change From Baseline in Bone Area of the Medial Femoral Condyle Surface of the Target Knee by qMRI to 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. | Posted | Mean | Standard Deviation | mm^2 | Baseline, Week 28 |
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| Secondary | Change From Baseline in Bone Area of the Medial Femoral Condyle Surface of the Target Knee by qMRI to 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. | Posted | Mean | Standard Deviation | mm^2 | Baseline, Week 52 |
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| Secondary | Change From Baseline in Joint Space Width (JSW) of the Target Knee to Week 52 | The JSW is the space measured between the 2 bones in the knee joint and this is assessed by x-ray. | 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. | Posted | Mean | Standard Deviation | mm | Baseline, Week 52 |
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| Secondary | Number of Participants Who Have Used at Least 1 Systemic Analgesic During the Study | Systemic analgesics included anti-inflammatory and anti-rheumatic products; analgesics; anti-diarrheals, intestinal, anti-inflammatory/anti-infective agents; and drugs for functional gastrointestinal disorders. | Analysis was based on mRS. | Posted | Count of Participants | Participants | Baseline up to Week 52 |
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| Secondary | Plasma Concentrations of GLPG1972 | 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. | Posted | Mean | Standard Deviation | μg/mL | 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 |
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| Secondary | Number of Participants With Treatment-emergent Adverse Event (TEAE) | TEAEs were defined as all adverse events (AEs) that occurred:
Number of participants with at least 1 TEAE (serious or non-serious) are reported. | Safety Set: All participants having taken at least one dose of IMP. | Posted | Count of Participants | Participants | Baseline up to 2-weeks after last dose of IMP (up to Week 54) |
|
Baseline up to 2-weeks after last dose of IMP (up to Week 54)
TEAEs were defined as all AEs that occurred:
Analysis was based on the safety set. All serious AEs are reported, TEAEs are reported at a threshold of 3%.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GLPG1972 75 mg | Participants received 1 film-coated tablet of GLPG1972 75 mg and 3 GLPG1972 matching placebo tablets, orally once daily for 52 weeks. | 0 | 234 | 17 | 234 | 114 | 234 |
| EG001 | GLPG1972 150 mg | 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. | 1 | 231 | 17 | 231 | 124 | 231 |
| EG002 | GLPG1972 300 mg | Participants received 4 film-coated tablets of GLPG1972 75 mg (total dose 300 mg), orally once daily for 52 weeks. | 0 | 232 | 18 | 232 | 105 | 232 |
| EG003 | Placebo | Participants received 4 film-coated tablets of GLPG1972 matching placebo, orally once daily for 52 weeks. | 0 | 234 | 18 | 234 | 130 | 234 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Myopathy | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Appendiceal abscess | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Burn infection | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Face injury | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Cervical cord compression | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Prostate cancer stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Systematic Assessment |
| |
| Invasive papillary breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Systematic Assessment |
| |
| Endometrial adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Systematic Assessment |
| |
| Malignant melanoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Systematic Assessment |
| |
| Glottis carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Systematic Assessment |
| |
| Intraductal proliferative breast lesion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Peritoneal cyst | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Abdominal incarcerated hernia | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Angle closure glaucoma | Eye disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Macular degeneration | Eye disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Depression suicidal | Psychiatric disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (23.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (23.0) | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Galapagos Medical Information | Galapagos NV | +32 15342900 | medicalinfo@glpg.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 29, 2020 | Apr 13, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
|
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|
Two-sided 95% confidence interval of the estimate without Dunnett adjustment.
| Superiority |
| 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. | Mixed Models Analysis | 0.939 | Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05). | Adjusted mean difference | 0.01200 | Standard Error of the Mean | 0.02585 | 2-Sided | 95 | -0.03868 | 0.06267 | Two-sided 95% confidence interval of the estimate without Dunnett adjustment. | Superiority |
| 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. | Mixed Models Analysis | 0.682 | Adjusted mean difference | 0.02329 | Standard Error of the Mean | 0.02536 | 2-Sided | 95 | -0.02641 | 0.07300 | Two-sided 95% confidence interval of the estimate without Dunnett adjustment. | Superiority |
| Placebo |
Participants received 4 film-coated tablets of GLPG1972 matching placebo, orally once daily for 52 weeks. |
|
|
|
| OG001 |
| GLPG1972 150 mg |
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. |
| OG002 | GLPG1972 300 mg | Participants received 4 film-coated tablets of GLPG1972 75 mg (total dose 300 mg), orally once daily for 52 weeks. |
| OG003 | Placebo | Participants received 4 film-coated tablets of GLPG1972 matching placebo, orally once daily for 52 weeks. |
|
|
|
| OG003 | Placebo | Participants received 4 film-coated tablets of GLPG1972 matching placebo, orally once daily for 52 weeks. |
|
|
|
| OG003 | Placebo | Participants received 4 film-coated tablets of GLPG1972 matching placebo, 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. |
| OG002 | GLPG1972 300 mg | Participants received 4 film-coated tablets of GLPG1972 75 mg (total dose 300 mg), orally once daily for 52 weeks. |
| OG003 | Placebo | Participants received 4 film-coated tablets of GLPG1972 matching placebo, orally once daily for 52 weeks. |
|
|
|
| OG003 | Placebo | Participants received 4 film-coated tablets of GLPG1972 matching placebo, orally once daily for 52 weeks. |
|
|
|
Participants received 4 film-coated tablets of GLPG1972 matching placebo, orally once daily for 52 weeks. |
|
|
|
Participants received 4 film-coated tablets of GLPG1972 matching placebo, orally once daily for 52 weeks. |
|
|
|
Participants received 4 film-coated tablets of GLPG1972 matching placebo, orally once daily for 52 weeks. |
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| OG003 | Placebo | Participants received 4 film-coated tablets of GLPG1972 matching placebo, orally once daily for 52 weeks. |
|
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| Title | Measurements |
|---|---|
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