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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-502799-22-00 | Other Identifier | EU-CT |
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The study met futility criteria at pre-planned interim analysis, showing no clinical efficacy of the investigational drug. Based on the lack of efficacy at the interim data review, the sponsor decided to terminate the study.
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This is dose-finding study of GSK3858279 in participants with moderate to severe knee osteoarthritis pain. The purpose of this study is to investigate and provide the data necessary to select the optimal effective and safe dose(s) of GSK3858279.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK3858279 - 60 mg weekly | Experimental | Participants received GSK3858279 60 milligram (mg) SC injection once per week for 16 weeks. |
|
| GSK3858279 - 240 mg every 2 weeks | Experimental | Participants received GSK3858279 240 mg SC injection every other week for 16 weeks. Placebo was given in the intervening week to maintain the blinding. |
|
| GSK3858279 - 240 mg weekly | Experimental | Participants received GSK3858279 240 mg SC injection once per week for 16 weeks. |
|
| GSK3858279 - 360 mg weekly | Experimental | Participants received GSK3858279 360 mg SC injection once per week for 16 weeks. |
|
| Placebo | Placebo Comparator | Participants received placebo subcutaneous (SC) injection once per week for 16 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK3858279 | Drug | GSK3858279 will be administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Weekly Average of Average Daily Knee Pain Intensity Using Numeric Rating Scale at Week 12 | Change from Baseline in knee pain due to Osteoarthritis were reported by weekly average of average daily pain numeric rating scale (NRS) at Week 12. The pain NRS is an 11-point scale (ranging from 0-10) for self-reporting of average daily knee pain where 0 indicates no pain, and 10 indicates the worst possible pain. For each participant, the weekly average of average daily pain score was calculated using the mean value of available daily pain scores falling in the assessment window for each week. A negative change from baseline indicates an improvement in pain. Participants were asked to complete the pain NRS questionnaire at the same time in the evening each day. Baseline scores were assigned based on an average of 7 days prior to day 1 dosing visit. Posterior mean change from baseline, 95 percent (%) credible interval (CI) was derived using Bayesian mixed model repeated measures. The data presented are the posterior mean with 95% confidence interval refers to 95% credible interval. | Baseline (Day -7 to Day -1) and at Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score At Week 12 | The WOMAC pain subscale have a recall period of 48 hours and includes 5 subscales of pain assessment: 1-walking on flat, 2-going up downstairs, 3-at night while in bed, 4-sitting or lying; 5-standing upright. The total WOMAC pain subscale score ranges from 0-10; where 0 is no pain and 10 is extreme pain. The WOMAC pain subscale score was calculated by taking average of the 5 pain subscales at each visit. Change from baseline was calculated for each visit as the mean WOMAC Pain subscale score minus the mean baseline WOMAC Pain subscale score. A negative change from baseline indicates an improvement in pain. Baseline WOMAC scores for each participant were assigned based on the score measured prior to first dosing on Day1 visit. Posterior mean change from baseline, 95 percent (%) credible interval (CI) was derived using Bayesian mixed model repeated measures. The data presented are the posterior mean change from baseline with a 95% confidence interval refers to 95% Credible Interval. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Cerritos | California | 90703 | United States | ||
| GSK Investigational Site |
Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
Of 314 participants enrolled, 4 participants were randomized but did not receive study dose, hence were excluded from the FAS.
A total of 314 participants were enrolled in the study. Out of which 310 participants were included in the full analysis set (FAS) population.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received placebo subcutaneous (SC) injection once per week for 16 weeks. |
| FG001 | GSK3858279 - 60 mg Weekly | Participants received GSK3858279 60 milligram (mg) SC injection once per week for 16 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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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 | Jul 26, 2024 | Oct 24, 2025 |
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| Placebo | Drug | Placebo will be administered. |
|
| Baseline (Day 1) and at Week 12 |
| Change From Baseline in WOMAC Physical Function Subscale Score at Week 12 | The WOMAC function subscale have a recall period of 48 hours and include 17 items of daily function assessments. The total WOMAC physical function subscale score ranges from 0-10 scale; where 0 is no difficulty and 10 is extremely difficult. The WOMAC physical function subscale score was calculated by taking the average of the 17 physical function subscales at each visit. Change from baseline was calculated for each visit as the mean WOMAC function subscale score minus the mean baseline WOMAC function subscale score. Baseline scores for each participant were assigned based on the score measured prior to first dosing on Day1 visit. A negative change from baseline indicated improvement. Posterior mean change from baseline, 95 percent (%) credible interval (CI) was derived using Bayesian mixed model repeated measures. The data presented are the posterior mean change from baseline with a 95% confidence interval refers to 95% Credible Interval. | Baseline (Day 1) and at Week 12 |
| Change From Baseline in Patient Global Assessment Of Disease (PtGA) at Week 12 | The PtGA is an assessment for disease conditions and intensity of knee osteoarthritis (OA) pain. Participants will respond on a Likert scale ranging from 1-5 based on the question "Considering all the ways in which your knee OA affects you, how do you feel your knee OA is doing today?" and to identify a number from 1 = very good (asymptomatic and no limitation to normal activities) to 5 = "very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicate worse conditions. Baseline scores for each participant were assigned based on the scores reported prior to first dosing on Day 1 visit. Posterior mean change from baseline, 95 percent (%) credible interval (CI) was derived using Bayesian mixed model repeated measures. The data presented are the posterior mean with a 95% confidence interval refers to 95% Credible Interval. | Baseline (Day 1) and at Week 12 |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESI) | AEs, SAEs, and AESIs were collected. An AE is any untoward medical occurrence in participant, temporally associated with use of study intervention, whether or not considered related to medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, medically important were categorized as SAEs. The AESIs of the study drug included serious and opportunistic infections, tuberculosis (TB) and TB reactivation, serious hypersensitivity reactions and Injection site reactions. | Up to 31 weeks |
| Number of Participants With Greater Than or Equal to (>=) Grade 3 Hematological/Clinical Chemistry Abnormalities According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCICTCAE) | The laboratory measurements included hematology and clinical chemistry. The parameters evaluated were Basophil, Eosinophil, Erythrocyte Mean Corpuscular Hemoglobin, Erythrocyte Mean Corpuscular Volume, Erythrocytes, Hematocrit, Hemoglobin, Lymphocyte, Monocyte, Neutrophils, Platelets and Reticulocytes, Alanine Aminotransferase, Albumin, Alkaline phosphatase, Aspartate Aminotransferase, Bilirubin, Calcium, Creatinine, Direct Bilirubin, Glucose, Potassium, Sodium and Urea. Worst case grade (G) increase from baseline grade was provided for all the laboratory tests that were gradable by National Cancer Institute Common Terminology Criteria (NCI CTCAE, Version 5.0). Data for any participants with the worst-case grade changes (Increase or equal to Grade 3 or Increase to Grade 4) post-baseline are reported. Missing baseline grade was assumed as grade 0. | Up to 31 weeks |
| Maximum Concentration (Cmax) of GSK3858279 | Blood samples were collected at the indicated time points for pharmacokinetic (PK) analysis of GSK3858279 . Pharmacokinetic analysis was conducted using a model based analysis using all available data. | Pre-dose: Day 1, Weeks 1, 2, 4, 8, 10, 11 and 12 |
| Time to Maximum Plasma Concentration (Tmax) of GSK3858279 | Tmax predicted from the population PK model fitted to GSK3859279 serum concentration time data collected at the indicated time points for PK analysis. | Pre-dose: Day 1, Weeks 1, 2, 4, 8, 10, 11 and 12 |
| Pre-Dose (Trough) Concentration at the End of the Dosing Interval (Ctau) of GSK3858279 | Ctau predicted from the population PK model fitted to GSK3859279 serum concentration time data collected at the indicated time points for PK analysis. | Pre-dose: Day 1, Weeks 1, 2, 4, 8, 10, 11 and 12 |
| Average Concentration Over a Dosing Interval (Cavg) of GSK3858279 | Cavg predicted from the population PK model fitted to GSK3859279 serum concentration time data collected at the indicated time points for PK analysis. | Pre-dose: Day 1, Weeks 1, 2, 4, 8, 10, 11 and 12 |
| Area Under the Time-Concentration Curve (AUC) Over the Dosing Interval (0-Tau) (AUC[0-Tau]) of GSK3858279 | AUC(0-tau) predicted from the population PK model fitted to GSK3859279 serum concentration time data collected at the indicated time points for PK analysis. | Pre-dose: Day 1, Weeks 1, 2, 4, 8, 10, 11 and 12 |
| Huntington Beach |
| California |
| 92647 |
| United States |
| GSK Investigational Site | Santa Clara | California | 95054 | United States |
| GSK Investigational Site | Cooper City | Florida | 33024 | United States |
| GSK Investigational Site | Cutler Bay | Florida | 33189 | United States |
| GSK Investigational Site | Miami | Florida | 33173 | United States |
| GSK Investigational Site | Miami | Florida | 33185 | United States |
| GSK Investigational Site | Wichita | Kansas | 67207 | United States |
| GSK Investigational Site | Louisville | Kentucky | 40213 | United States |
| GSK Investigational Site | New Orleans | Louisiana | 70115 | United States |
| GSK Investigational Site | Henderson | Nevada | 89052 | United States |
| GSK Investigational Site | Williamsville | New York | 14221 | United States |
| GSK Investigational Site | Greensboro | North Carolina | 27410 | United States |
| GSK Investigational Site | Duncansville | Pennsylvania | 16635 | United States |
| GSK Investigational Site | Charlottesville | Virginia | 22911 | United States |
| GSK Investigational Site | Buenos Aires | C1128AAF | Argentina |
| GSK Investigational Site | Buenos Aires-San Isidro | 1643 | Argentina |
| GSK Investigational Site | Ciudad Autonoma Buenos Aires | C1417 | Argentina |
| GSK Investigational Site | Ciudad AutOnoma de Buenos Aire | 1118 | Argentina |
| GSK Investigational Site | Ciudad Autonoma de Buenos Aire | C1046AAQ | Argentina |
| GSK Investigational Site | Mar del Plata | B7600FYK | Argentina |
| GSK Investigational Site | Botany | New South Wales | 2019 | Australia |
| GSK Investigational Site | Kotara | New South Wales | 2289 | Australia |
| GSK Investigational Site | Sydney | New South Wales | 2010 | Australia |
| GSK Investigational Site | Camberwell | Victoria | 3124 | Australia |
| GSK Investigational Site | Victoria | British Columbia | V8V 4A1 | Canada |
| GSK Investigational Site | Brampton | Ontario | L6T 0G1 | Canada |
| GSK Investigational Site | Guelph | Ontario | N1H 1B1 | Canada |
| GSK Investigational Site | Sarnia | Ontario | N7T 4X3 | Canada |
| GSK Investigational Site | Toronto | Ontario | M5T 2S8 | Canada |
| GSK Investigational Site | Toronto | Ontario | M9V 4B4 | Canada |
| GSK Investigational Site | Winchester | Ontario | K0C 2K0 | Canada |
| GSK Investigational Site | Joliette | Quebec | J6E 6A9 | Canada |
| GSK Investigational Site | Sherbrooke | Quebec | J1L 0H8 | Canada |
| GSK Investigational Site | Trois-Rivières | Quebec | G9A 3X2 | Canada |
| GSK Investigational Site | Beijing | 100083 | China |
| GSK Investigational Site | Beijing | 100730 | China |
| GSK Investigational Site | Changchun | 130021 | China |
| GSK Investigational Site | Chengdu | 610041 | China |
| GSK Investigational Site | Guangzhou | 510000 | China |
| GSK Investigational Site | Hohhot | 010017 | China |
| GSK Investigational Site | Nanjing | 210009 | China |
| GSK Investigational Site | Shanghai | 200011 | China |
| GSK Investigational Site | Shanghai | 200040 | China |
| GSK Investigational Site | Shanghai | 200065 | China |
| GSK Investigational Site | Shenyang | 110022 | China |
| GSK Investigational Site | Shijiazhuang | 050051 | China |
| GSK Investigational Site | Tianjin | 300192 | China |
| GSK Investigational Site | Zhuzhou | 412007 | China |
| GSK Investigational Site | Dax | 40107 | France |
| GSK Investigational Site | La Roche-sur-Yon | 85925 | France |
| GSK Investigational Site | La Rochelle | 17019 | France |
| GSK Investigational Site | Montpellier | 34000 | France |
| GSK Investigational Site | Paris | 75012 | France |
| GSK Investigational Site | Berlin | 10117 | Germany |
| GSK Investigational Site | Hamburg | 20095 | Germany |
| GSK Investigational Site | Hamburg | 22415 | Germany |
| GSK Investigational Site | Magdeburg | 39120 | Germany |
| GSK Investigational Site | Fukuoka | 834-0115 | Japan |
| GSK Investigational Site | Ibaraki | 300-1234 | Japan |
| GSK Investigational Site | Ibaraki | 300-1253 | Japan |
| GSK Investigational Site | Nagano | 390-8601 | Japan |
| GSK Investigational Site | Nagano | 395-8505 | Japan |
| GSK Investigational Site | Osaka | 543-0027 | Japan |
| GSK Investigational Site | Saitama | 330-0074 | Japan |
| GSK Investigational Site | Shimane | 693-8501 | Japan |
| GSK Investigational Site | Tokyo | 103-0027 | Japan |
| GSK Investigational Site | Tokyo | 104-0031 | Japan |
| GSK Investigational Site | Tokyo | 113-8431 | Japan |
| GSK Investigational Site | Chihuahua City | 31000 | Mexico |
| GSK Investigational Site | Guadalajara | 44650 | Mexico |
| GSK Investigational Site | Mexicali | 21200 | Mexico |
| GSK Investigational Site | Mérida | CP 97070 | Mexico |
| GSK Investigational Site | Torreón | 27000 | Mexico |
| GSK Investigational Site | Cape Town | 7130 | South Africa |
| GSK Investigational Site | Cape Town | 7405 | South Africa |
| GSK Investigational Site | Gauteng | 1619 | South Africa |
| GSK Investigational Site | Johannesburg | 2113 | South Africa |
| GSK Investigational Site | Stellenbosch | 7600 | South Africa |
| GSK Investigational Site | Seoul | 03080 | South Korea |
| GSK Investigational Site | Seoul | 06973 | South Korea |
| GSK Investigational Site | Seoul | 07441 | South Korea |
| GSK Investigational Site | A Coruña | 15006 | Spain |
| GSK Investigational Site | Barcelona | 08430 | Spain |
| GSK Investigational Site | Barcelona | 08540 | Spain |
| GSK Investigational Site | Madrid | 28046 | Spain |
| GSK Investigational Site | Santander | 39008 | Spain |
| GSK Investigational Site | Santiago de Compostela | 15702 | Spain |
| GSK Investigational Site | Seville | 41014 | Spain |
| GSK Investigational Site | Blackpool | FY2 0JH | United Kingdom |
| GSK Investigational Site | Cannock | WS11 0BN | United Kingdom |
| GSK Investigational Site | London | EN5 3DJ | United Kingdom |
| GSK Investigational Site | Manchester | M13 9NQ | United Kingdom |
| FG002 | GSK3858279 - 240 mg Every 2 Weeks | Participants received GSK3858279 240 mg SC injection every other week for 16 weeks. Placebo was given in the intervening week to maintain the blinding. |
| FG003 | GSK3858279 - 240 mg Weekly | Participants received GSK3858279 240 mg SC injection once per week for 16 weeks. |
| FG004 | GSK3858279 - 360 mg Weekly | Participants received GSK3858279 360 mg SC injection once per week for 16 weeks. |
| Full Analysis Population |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
Full analysis set population included all randomized participants who received at least one dose of study intervention. Data was reported according to the randomized study intervention.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received placebo SC injection once per week for 16 weeks. |
| BG001 | GSK3858279 - 60 mg Weekly | Participants received GSK3858279 60 mg SC injection once per week for 16 weeks. |
| BG002 | GSK3858279 - 240 mg Every 2 Weeks | Participants received GSK3858279 240 mg SC injection every other week for 16 weeks. Placebo was given in the intervening week to maintain the blinding. |
| BG003 | GSK3858279 - 240 mg Weekly | Participants received GSK3858279 240 mg SC injection once per week for 16 weeks. |
| BG004 | GSK3858279 - 360 mg Weekly | Participants received GSK3858279 360 mg SC injection once per week for 16 weeks. |
| BG005 | 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 |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| 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 Weekly Average of Average Daily Knee Pain Intensity Using Numeric Rating Scale at Week 12 | Change from Baseline in knee pain due to Osteoarthritis were reported by weekly average of average daily pain numeric rating scale (NRS) at Week 12. The pain NRS is an 11-point scale (ranging from 0-10) for self-reporting of average daily knee pain where 0 indicates no pain, and 10 indicates the worst possible pain. For each participant, the weekly average of average daily pain score was calculated using the mean value of available daily pain scores falling in the assessment window for each week. A negative change from baseline indicates an improvement in pain. Participants were asked to complete the pain NRS questionnaire at the same time in the evening each day. Baseline scores were assigned based on an average of 7 days prior to day 1 dosing visit. Posterior mean change from baseline, 95 percent (%) credible interval (CI) was derived using Bayesian mixed model repeated measures. The data presented are the posterior mean with 95% confidence interval refers to 95% credible interval. | The analysis was performed on the full analysis set (FAS) that included all randomized participants who received at least one dose of study intervention. Only those participants who had a measured outcome used in estimation or imputed outcome based on composite intercurrent event strategy at the current time point were included in the overall number of participants analyzed field. | Posted | Mean | 95% Confidence Interval | Scores on Scale | Baseline (Day -7 to Day -1) and at Week 12 |
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| Secondary | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score At Week 12 | The WOMAC pain subscale have a recall period of 48 hours and includes 5 subscales of pain assessment: 1-walking on flat, 2-going up downstairs, 3-at night while in bed, 4-sitting or lying; 5-standing upright. The total WOMAC pain subscale score ranges from 0-10; where 0 is no pain and 10 is extreme pain. The WOMAC pain subscale score was calculated by taking average of the 5 pain subscales at each visit. Change from baseline was calculated for each visit as the mean WOMAC Pain subscale score minus the mean baseline WOMAC Pain subscale score. A negative change from baseline indicates an improvement in pain. Baseline WOMAC scores for each participant were assigned based on the score measured prior to first dosing on Day1 visit. Posterior mean change from baseline, 95 percent (%) credible interval (CI) was derived using Bayesian mixed model repeated measures. The data presented are the posterior mean change from baseline with a 95% confidence interval refers to 95% Credible Interval. | The analysis was performed on FAS population which included all randomized participants who received at least one dose of study intervention. Only those participants who had a measured outcome used in estimation or imputed outcome based on composite intercurrent event strategy at the current time point were included in the overall number of participants analyzed field. | Posted | Mean | 95% Confidence Interval | Scores on Scale | Baseline (Day 1) and at Week 12 |
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| Secondary | Change From Baseline in WOMAC Physical Function Subscale Score at Week 12 | The WOMAC function subscale have a recall period of 48 hours and include 17 items of daily function assessments. The total WOMAC physical function subscale score ranges from 0-10 scale; where 0 is no difficulty and 10 is extremely difficult. The WOMAC physical function subscale score was calculated by taking the average of the 17 physical function subscales at each visit. Change from baseline was calculated for each visit as the mean WOMAC function subscale score minus the mean baseline WOMAC function subscale score. Baseline scores for each participant were assigned based on the score measured prior to first dosing on Day1 visit. A negative change from baseline indicated improvement. Posterior mean change from baseline, 95 percent (%) credible interval (CI) was derived using Bayesian mixed model repeated measures. The data presented are the posterior mean change from baseline with a 95% confidence interval refers to 95% Credible Interval. | The analysis was performed on FAS population which included all randomized participants who received at least one dose of study intervention. Only those participants who had a measured outcome used in estimation or imputed outcome based on composite intercurrent event strategy at the current time point were included in the overall number of participants analyzed field. | Posted | Mean | 95% Confidence Interval | Scores on Scale | Baseline (Day 1) and at Week 12 |
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| Secondary | Change From Baseline in Patient Global Assessment Of Disease (PtGA) at Week 12 | The PtGA is an assessment for disease conditions and intensity of knee osteoarthritis (OA) pain. Participants will respond on a Likert scale ranging from 1-5 based on the question "Considering all the ways in which your knee OA affects you, how do you feel your knee OA is doing today?" and to identify a number from 1 = very good (asymptomatic and no limitation to normal activities) to 5 = "very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicate worse conditions. Baseline scores for each participant were assigned based on the scores reported prior to first dosing on Day 1 visit. Posterior mean change from baseline, 95 percent (%) credible interval (CI) was derived using Bayesian mixed model repeated measures. The data presented are the posterior mean with a 95% confidence interval refers to 95% Credible Interval. | The analysis was performed on FAS population which included all randomized participants who received at least one dose of study intervention. Only those participants who had a measured outcome used in estimation or imputed outcome based on composite intercurrent event strategy at the current time point were included in the overall number of participants analyzed field. | Posted | Mean | 95% Confidence Interval | Scores on Scale | Baseline (Day 1) and at Week 12 |
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| Secondary | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESI) | AEs, SAEs, and AESIs were collected. An AE is any untoward medical occurrence in participant, temporally associated with use of study intervention, whether or not considered related to medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, medically important were categorized as SAEs. The AESIs of the study drug included serious and opportunistic infections, tuberculosis (TB) and TB reactivation, serious hypersensitivity reactions and Injection site reactions. | The analysis was performed on safety population which included all participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | Up to 31 weeks |
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| Secondary | Number of Participants With Greater Than or Equal to (>=) Grade 3 Hematological/Clinical Chemistry Abnormalities According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCICTCAE) | The laboratory measurements included hematology and clinical chemistry. The parameters evaluated were Basophil, Eosinophil, Erythrocyte Mean Corpuscular Hemoglobin, Erythrocyte Mean Corpuscular Volume, Erythrocytes, Hematocrit, Hemoglobin, Lymphocyte, Monocyte, Neutrophils, Platelets and Reticulocytes, Alanine Aminotransferase, Albumin, Alkaline phosphatase, Aspartate Aminotransferase, Bilirubin, Calcium, Creatinine, Direct Bilirubin, Glucose, Potassium, Sodium and Urea. Worst case grade (G) increase from baseline grade was provided for all the laboratory tests that were gradable by National Cancer Institute Common Terminology Criteria (NCI CTCAE, Version 5.0). Data for any participants with the worst-case grade changes (Increase or equal to Grade 3 or Increase to Grade 4) post-baseline are reported. Missing baseline grade was assumed as grade 0. | The analysis was performed on safety population which included all participants who received at least 1 dose of study treatment. The overall number of participants analyzed represents only those participants available at the specified time points and evaluable for this outcome measure. | Posted | Count of Participants | Participants | Up to 31 weeks |
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| Secondary | Maximum Concentration (Cmax) of GSK3858279 | Blood samples were collected at the indicated time points for pharmacokinetic (PK) analysis of GSK3858279 . Pharmacokinetic analysis was conducted using a model based analysis using all available data. | The analysis was performed on PK set which included all randomized participants in the Safety Population who had at least 1 dose of GSK3858279 and at least 1 non-missing PK assessment (Non-quantifiable values were considered as non-missing values). Only those participants with data available at specified time points have been analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms/milliliter (ng/mL) | Pre-dose: Day 1, Weeks 1, 2, 4, 8, 10, 11 and 12 |
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| Secondary | Time to Maximum Plasma Concentration (Tmax) of GSK3858279 | Tmax predicted from the population PK model fitted to GSK3859279 serum concentration time data collected at the indicated time points for PK analysis. | The analysis was performed on PK set which included all randomized participants in the Safety Population who had at least 1 dose of GSK3858279 and at least 1 non-missing PK assessment (Non-quantifiable values were considered as non-missing values). Only those participants with data available at specified time points have been analyzed. | Posted | Median | Full Range | Day | Pre-dose: Day 1, Weeks 1, 2, 4, 8, 10, 11 and 12 |
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| Secondary | Pre-Dose (Trough) Concentration at the End of the Dosing Interval (Ctau) of GSK3858279 | Ctau predicted from the population PK model fitted to GSK3859279 serum concentration time data collected at the indicated time points for PK analysis. | The analysis was performed on PK set which included all randomized participants in the Safety Population who had at least 1 dose of GSK3858279 and at least 1 non-missing PK assessment (Non-quantifiable values were considered as non-missing values). Only those participants with data available at specified time points have been analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Pre-dose: Day 1, Weeks 1, 2, 4, 8, 10, 11 and 12 |
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| Secondary | Average Concentration Over a Dosing Interval (Cavg) of GSK3858279 | Cavg predicted from the population PK model fitted to GSK3859279 serum concentration time data collected at the indicated time points for PK analysis. | The analysis was performed on PK set which included all randomized participants in the Safety Population who had at least 1 dose of GSK3858279 and at least 1 non-missing PK assessment (Non-quantifiable values were considered as non-missing values). Only those participants with data available at specified time points have been analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Pre-dose: Day 1, Weeks 1, 2, 4, 8, 10, 11 and 12 |
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| Secondary | Area Under the Time-Concentration Curve (AUC) Over the Dosing Interval (0-Tau) (AUC[0-Tau]) of GSK3858279 | AUC(0-tau) predicted from the population PK model fitted to GSK3859279 serum concentration time data collected at the indicated time points for PK analysis. | The analysis was performed on PK set which included all randomized participants in the Safety Population who had at least 1 dose of GSK3858279 and at least 1 non-missing PK assessment (Non-quantifiable values were considered as non-missing values). Only those participants with data available at specified time points have been analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | day*ng/mL | Pre-dose: Day 1, Weeks 1, 2, 4, 8, 10, 11 and 12 |
|
All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31.
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
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 | Placebo | Participants received placebo SC injection once per week for 16 weeks. | 0 | 105 | 4 | 105 | 37 | 105 |
| EG001 | GSK3858279 - 60 mg Weekly | Participants received GSK3858279 60 mg SC injection once per week for 16 weeks. | 0 | 50 | 3 | 50 | 14 | 50 |
| EG002 | GSK3858279 - 240 mg Every 2 Weeks | Participants received GSK3858279 240 mg SC injection every other week for 16 weeks. Placebo was given in the intervening week to maintain the blinding. | 0 | 51 | 0 | 51 | 25 | 51 |
| EG003 | GSK3858279 - 240 mg Weekly | Participants received GSK3858279 240 mg SC injection once per week for 16 weeks. | 0 | 51 | 1 | 51 | 20 | 51 |
| EG004 | GSK3858279 - 360 mg Weekly | Participants received GSK3858279 360 mg SC injection once per week for 16 weeks. | 0 | 53 | 2 | 53 | 22 | 53 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute coronary syndrome | Cardiac disorders | MedDra 27.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDra 27.1 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Tubo-ovarian abscess | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDra 27.1 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDra 27.1 | Systematic Assessment |
| |
| Lipoedema | Metabolism and nutrition disorders | MedDra 27.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDra 27.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDra 27.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDra 27.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDra 27.1 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDra 27.1 | Systematic Assessment |
| |
| Injection site bruising | General disorders | MedDra 27.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDra 27.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDra 27.1 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data do not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
| Prot_004.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 12, 2024 | Oct 24, 2025 | SAP_005.pdf |
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| D009140 | Musculoskeletal Diseases |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
| Male |
|
| Asian |
|
| Black or African American |
|
| American Indian or Alaska Native |
|
| Not reported |
|
| Unknown |
|
Posterior mean difference with 95% credible interval is reported.
| Mixed Models Analysis | Analyzed using a joint model for change from baseline in average weekly pain score and time to intercurrent event handled using a composite strategy. | Difference in Posterior Mean Change | 0.25 | 2-Sided | 95 | -0.46 | 0.95 | Other | Analysis performed using a Bayesian mixed model repeated measures adjusting for treatment, week, baseline, region and the treatment by week and baseline by week interactions using vague priors. | Posterior mean difference with 95% credible interval is reported. |
| Mixed Models Analysis | Analyzed using a joint model for change from baseline in average weekly pain score and time to intercurrent event handled using a composite strategy. | Difference in Posterior Mean Change | 0.39 | 2-Sided | 95 | -0.31 | 1.10 | Other | Analysis performed using a Bayesian mixed model repeated measures adjusting for treatment, week, baseline, region and the treatment by week and baseline by week interactions using vague priors. | Posterior mean difference with 95% credible interval is reported. |
| Mixed Models Analysis | Analyzed using a joint model for change from baseline in average weekly pain score and time to intercurrent event handled using a composite strategy. | Difference in Posterior Mean Change | 0.11 | 2-Sided | 95 | -0.60 | 0.80 | Other | Analysis performed using a Bayesian mixed model repeated measures adjusting for treatment, week, baseline, region and the treatment by week and baseline by week interactions using vague priors. | Posterior mean difference with 95% credible interval is reported. |
| OG001 | GSK3858279 - 60 mg Weekly | Participants received GSK3858279 60 mg SC injection once per week for 16 weeks. |
| OG002 | GSK3858279 - 240 mg Every 2 Weeks | Participants received GSK3858279 240 mg SC injection every other week for 16 weeks. Placebo was given in the intervening week to maintain the blinding. |
| OG003 | GSK3858279 - 240 mg Weekly | Participants received GSK3858279 240 mg SC injection once per week for 16 weeks. |
| OG004 | GSK3858279 - 360 mg Weekly | Participants received GSK3858279 360 mg SC injection once per week for 16 weeks. |
|
|
| GSK3858279 - 60 mg Weekly |
Participants received GSK3858279 60 mg SC injection once per week for 16 weeks. |
| OG002 | GSK3858279 - 240 mg Every 2 Weeks | Participants received GSK3858279 240 mg SC injection every other week for 16 weeks. Placebo was given in the intervening week to maintain the blinding. |
| OG003 | GSK3858279 - 240 mg Weekly | Participants received GSK3858279 240 mg SC injection once per week for 16 weeks. |
| OG004 | GSK3858279 - 360 mg Weekly | Participants received GSK3858279 360 mg SC injection once per week for 16 weeks. |
|
|
Participants received GSK3858279 60 mg SC injection once per week for 16 weeks. |
| OG002 | GSK3858279 - 240 mg Every 2 Weeks | Participants received GSK3858279 240 mg SC injection every other week for 16 weeks. Placebo was given in the intervening week to maintain the blinding. |
| OG003 | GSK3858279 - 240 mg Weekly | Participants received GSK3858279 240 mg SC injection once per week for 16 weeks. |
| OG004 | GSK3858279 - 360 mg Weekly | Participants received GSK3858279 360 mg SC injection once per week for 16 weeks. |
|
|
Participants received GSK3858279 240 mg SC injection every other week for 16 weeks. Placebo was given in the intervening week to maintain the blinding.
| OG003 | GSK3858279 - 240 mg Weekly | Participants received GSK3858279 240 mg SC injection once per week for 16 weeks. |
| OG004 | GSK3858279 - 360 mg Weekly | Participants received GSK3858279 360 mg SC injection once per week for 16 weeks. |
|
|
Participants received GSK3858279 60 mg SC injection once per week for 16 weeks. |
| OG002 | GSK3858279 - 240 mg Every 2 Weeks | Participants received GSK3858279 240 mg SC injection every other week for 16 weeks. Placebo was given in the intervening week to maintain the blinding. |
| OG003 | GSK3858279 - 240 mg Weekly | Participants received GSK3858279 240 mg SC injection once per week for 16 weeks. |
| OG004 | GSK3858279 - 360 mg Weekly | Participants received GSK3858279 360 mg SC injection once per week for 16 weeks. |
|
|
| OG003 | GSK3858279 - 360 mg Weekly | Participants received GSK3858279 360 mg SC injection once per week for 16 weeks. |
|
|
| GSK3858279 - 360 mg Weekly |
Participants received GSK3858279 360 mg SC injection once per week for 16 weeks. |
|
|
| OG003 | GSK3858279 - 360 mg Weekly | Participants received GSK3858279 360 mg SC injection once per week for 16 weeks. |
|
|
| OG003 |
| GSK3858279 - 360 mg Weekly |
Participants received GSK3858279 360 mg SC injection once per week for 16 weeks. |
|
|
| OG003 | GSK3858279 - 360 mg Weekly | Participants received GSK3858279 360 mg SC injection once per week for 16 weeks. |
|
|
|
|
|
|
|