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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-502313-28-00 | 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 a multicenter randomized, double-blind, placebo-controlled phase 2 study to evaluate efficacy, safety, tolerability, pharmacokinetics, and target engagement of GSK3858279 in adult participants with chronic Diabetic Peripheral Neuropathic Pain (DPNP). The primary objective of the study is to assess the efficacy of GSK3858279 in participants with DPNP who have been unable to sufficiently manage their pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK3858279 60 mg | Experimental | Participants received GSK3858279 SC injection 60 milligram (mg) once per week for 12 weeks. |
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| GSK3858279 360 mg | Experimental | Participants received GSK3858279 SC injection 360 mg once per week for 12 weeks. |
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| Placebo | Placebo Comparator | Participants received matching placebo subcutaneous (SC) injection once per week for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK3858279 | Drug | GSK3858279 was administered |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Weekly Average of Average Daily Pain Score at Week 12, Assessed on the Numeric Rating Scale (NRS) | The change from baseline (CFB) in the weekly average of the average daily pain score at Week 12 was assessed using Numeric Rating Scale (NRS). Participants recorded their average daily pain response daily using a Brief Pain Inventory Item 5. It is a single item designed for self-reporting average pain score for past 24 hours. Participants were asked to mark their average pain intensity daily, using the NRS, on an 11-point scale (0 = no pain, 10 = worst pain imaginable). The weekly average was computed as weekly average of the average daily scores (range: 0-10), where higher scores indicate more severe pain. A negative CFB indicates pain improvement. Baseline was defined as the average score over the 7 days before dosing (Day -7 to -1). Posterior mean CFB and the 95% credible interval were derived using a Bayesian mixed model repeated measures analysis. The data presented as "Mean" refers to the 'posterior mean' and "95% confidence interval" to '95% credible interval'. | Baseline (Day -7 to Day -1) and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs), Serious AE (SAEs) and AEs of Special Interest (AESI) | Adverse events, 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 SAE. AESIs of the study drug includes serious and opportunistic infections, tuberculosis (TB), serious hypersensitivity reactions and Injection site reactions. |
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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 | Anniston | Alabama | 36207 | 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/
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A total of 147 participants were enrolled in the study. Three participants were randomized but did not receive any study drug, hence were excluded from the FAS.
A total of 147 participants were enrolled in the study, Out of which 144 participants were included in the full analysis set (FAS) population.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received matching placebo subcutaneous (SC) injection once per week for 12 weeks. |
| FG001 | GSK3858279 60 mg | Participants received GSK3858279 SC injection 60 milligram (mg) once per week for 12 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 | Mar 26, 2024 | Oct 7, 2025 |
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| Placebo |
| Drug |
Placebo was administered |
|
| Up to 27 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 (NCI-CTCAE) | The laboratory measurements included hematology and clinical chemistry. The parameters evaluated were Eosinophils, Hemoglobin, White blood cell, Lymphocyte count, Neutrophil count and Platelet count, Alanine aminotransferase, Alkaline phosphatase, Aspartate aminotransferase, Blood bilirubin, Hypercalcemia, Hypocalcemia, Cholesterol, Creatine Phosphokinase, Creatinine, Gamma Glutamyl Transferase (GGT), Hypoglycemia, Hyperkalemia, Hypernatremia and Hypertriglyceridemia. Worst case grade (G) increase from baseline grade was evaluated for all the laboratory tests that were gradable by National Cancer Institute Common Terminology Criteria (NCI CTCAE). Data is presented for only those parameters for which participants had worst case >= Grade 3 increase from Baseline. | Up to 27 weeks |
| Maximum Concentration (Cmax) of GSK3858279 | Blood samples were collected for the determination of serum concentrations of GSK3858279 from which pharmacokinetic (PK) parameters were determined. Cmax was predicted from the population PK model fitted to GSK3859279 serum concentration time data collected at the indicated time points for PK analysis. | Pre-dose, Week 1, Week 4, Week 7, Week 8, Week 11, Week 12, Week 16, Week 20 and Week 27 post dose |
| Time to Maximum Concentration (Tmax) of GSK3858279 | Blood samples were collected for the determination of serum concentrations of GSK3858279 from which PK parameters were determined. Tmax was predicted from the population PK model fitted to GSK3859279 serum concentration time data collected at the indicated time points for PK analysis. | Pre-dose, Week 1, Week 4, Week 7, Week 8, Week 11, Week 12, Week 16, Week 20 and Week 27 post dose |
| Trough Concentration at the End of the Dosing Interval (Ctau) of GSK3858279 | Blood samples were collected for the determination of serum concentrations of GSK3858279 from which PK parameters were determined. Ctau is defined as the lowest concentration reached by a drug before the next dose is administered. Ctau was predicted from the population PK model fitted to GSK3859279 serum concentration time data collected at the indicated time points for PK analysis. | Pre-dose, Week 1, Week 4, Week 7, Week 8, Week 11, Week 12, Week 16, Week 20 and Week 27 post dose |
| Average Concentration Over a Dosing Interval (Cavg) of GSK3858279 | Blood samples were collected for the determination of serum concentrations of GSK3858279 from which PK parameters were determined. Cavg is the average concentration over the dosing interval (weekly). Cavg was predicted from the population PK model fitted to GSK3859279 serum concentration time data collected at the indicated time points for PK analysis. | Pre-dose, Week 1, Week 4, Week 7, Week 8, Week 11, Week 12, Week 16, Week 20 and Week 27 post dose |
| Area Under the Time-Concentration Curve (AUC) Over the Dosing Interval (AUC[0-Tau]) of GSK3858279 | Blood samples were collected for the determination of serum concentrations of GSK3858279 from which PK parameters were determined. AUC(0-tau) was predicted from the population model fitted to GSK3859279 serum concentration time data collected at the indicated time points for PK analysis. | Pre-dose, Week 1, Week 4, Week 7, Week 8, Week 11, Week 12, Week 16, Week 20 and Week 27 post dose |
| Change From Baseline in the Short-Form Mcgill Pain Questionnaire Total Score Over Time | The McGill pain questionnaire Short Form 2 is a 22-item questionnaire total score, which evaluated multi-dimensional pain over time. The questionnaire consists of 22 different descriptors of pain, and each item is rated based on a 0-10 pain intensity scale with 0 indicating no pain and 10 as worst possible pain. The total score was calculated as the mean of all item ratings. Higher scores indicate more severe pain. Baseline is defined as the last assessment prior to the first dose with a non-missing value, including those from unscheduled visits. Posterior mean change from baseline, 95 percent (%) credible interval (CI) was derived using Bayesian mixed model repeated measures. The data presented as 'Mean' refers to 'posterior mean' and '95% confidence interval' refers to '95% credible intervals'. | Baseline (Day1), Week 2, Week 4, Week 8 and Week 12 |
| Change From Baseline in the Weekly Average of Average Daily Pain Score Over Time, Assessed on the NRS | The change from baseline (CFB) in the weekly average of the average daily pain score at indicated time points was assessed using NRS. Participants recorded their average daily pain response daily using a Brief Pain Inventory Item 5. It is a single item designed for self-reporting average pain score for past 24 hours. Participants were asked to mark their average pain intensity daily, using the NRS, on an 11-point scale (0 = no pain, 10 = worst pain imaginable). The weekly average was computed as weekly average of the average daily scores (range: 0-10), where higher scores indicate more severe pain. A negative CFB indicates pain improvement. Baseline was defined as the average score over the 7 days before dosing (Day - 7 to -1). Posterior mean CFB and the 95% credible interval were derived using a Bayesian mixed model repeated measures analysis. The data presented as 'Mean' refers to the 'posterior mean' and '95% confidence interval' to the '95% credible interval'. | Baseline (Day -7 to Day -1), Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12 |
| Proportion of Participants With Greater Than or Equal To (>=) 30 Percentage (%) Reduction From Baseline in the Weekly Average of Average Daily Pain Intensity at Week 12, Assessed on the NRS | The proportion of participants who achieved >=30 percentage reduction from Baseline (responders) in the weekly average of the average daily pain score at Week 12 as measured by NRS is reported. Participants were instructed to assess their average daily pain daily, and to record the response in a Brief Pain Inventory item 5. It is a single item designed to capture information on the self- reported average pain score over the past 24 hours. Participants were asked to mark their pain- intensity daily, using the NRS, on an 11- point scale (0-10), with 0 = no pain, and 10 = worst pain imaginable. The weekly average was computed as weekly average of the average daily scores (range: 0-10), where higher scores indicate more severe pain. The data is presented for proportion of responders where 'Mean' refers to 'posterior mean proportion' and '95% confidence interval' refers to '95% credible interval'. | At Week 12 |
| Proportion of Participants With Greater Than or Equal To >= 50 % Reduction From Baseline in the Weekly Average of Average Daily Pain Score at Week 12, Assessed on the NRS | The proportion of participants who achieved >=50 percentage reduction from Baseline (responders) in the weekly average of the average daily pain score at Week 12 as measured by NRS is reported. Participants were instructed to assess their average daily pain daily, and to record the response in a Brief Pain Inventory item 5. It is a single item designed to capture information on the self- reported average pain score over the past 24 hours. Participants were asked to mark their pain- intensity daily, using the NRS, on an 11- point scale (0-10), with 0 = no pain, and 10 = worst pain imaginable. The weekly average was computed as weekly average of the average daily scores (range: 0-10), where higher scores indicate more severe pain. The data is presented for proportion of responders where 'Mean' refers to 'posterior mean proportion' and '95% confidence interval' refers to '95% credible interval'. | At Week 12 |
| Surprise |
| Arizona |
| 85378 |
| United States |
| GSK Investigational Site | Cerritos | California | 90703 | United States |
| GSK Investigational Site | Lomita | California | 90717 | United States |
| GSK Investigational Site | Largo | Florida | 33777 | United States |
| GSK Investigational Site | Miami | Florida | 33135 | United States |
| GSK Investigational Site | Miami | Florida | 33175 | United States |
| GSK Investigational Site | West Palm Beach | Florida | 33401 | United States |
| GSK Investigational Site | Decatur | Georgia | 30030 | United States |
| GSK Investigational Site | Chicago | Illinois | 60611 | United States |
| GSK Investigational Site | Waltham | Massachusetts | 02451 | United States |
| GSK Investigational Site | Williamsville | New York | 14221 | United States |
| GSK Investigational Site | Huntersville | North Carolina | 28078 | United States |
| GSK Investigational Site | Lancaster | South Carolina | 29720 | United States |
| GSK Investigational Site | Cypress | Texas | 77429 | United States |
| GSK Investigational Site | DeSoto | Texas | 75154 | United States |
| GSK Investigational Site | Houston | Texas | 77030 | United States |
| GSK Investigational Site | McAllen | Texas | 78501 | United States |
| GSK Investigational Site | Bellevue | Washington | 98007 | United States |
| GSK Investigational Site | New Westminster | British Columbia | V3L 3W4 | Canada |
| GSK Investigational Site | Vancouver | British Columbia | V5Y 3W2 | Canada |
| GSK Investigational Site | Winnipeg | Manitoba | R3C 0N2 | Canada |
| GSK Investigational Site | Toronto | Ontario | L6S 0C6 | Canada |
| GSK Investigational Site | Toronto | Ontario | M5G 2C4 | Canada |
| GSK Investigational Site | Beijing | 100032 | China |
| GSK Investigational Site | Guangzhou | 510000 | China |
| GSK Investigational Site | Harbin | 150001 | China |
| GSK Investigational Site | Luoyang | 471003 | China |
| GSK Investigational Site | Shanghai | 200032 | China |
| GSK Investigational Site | Wuhan | 430030 | China |
| GSK Investigational Site | Yueyang | 414000 | China |
| GSK Investigational Site | Corbeil-Essonnes | 91100 | France |
| GSK Investigational Site | Mulhouse | 68100 | France |
| GSK Investigational Site | Bad Homburg | 61348 | Germany |
| GSK Investigational Site | Mainz | 55128 | Germany |
| GSK Investigational Site | Münster | 48145 | Germany |
| GSK Investigational Site | Wallerfing | 94574 | Germany |
| GSK Investigational Site | Chiba | 260-0804 | Japan |
| GSK Investigational Site | Fukuoka | 807-8556 | Japan |
| GSK Investigational Site | Gunma | 370-3573 | Japan |
| GSK Investigational Site | Hokkaido | 060-0061 | Japan |
| GSK Investigational Site | Ibaraki | 300-0028 | Japan |
| GSK Investigational Site | Kanagawa | 211-8533 | Japan |
| GSK Investigational Site | Osaka | 565-0853 | Japan |
| GSK Investigational Site | Tochigi | 321-0204 | Japan |
| GSK Investigational Site | Tochigi | 321-0974 | Japan |
| GSK Investigational Site | Tochigi | 322-8550 | Japan |
| GSK Investigational Site | Tokyo | 103-0027 | Japan |
| GSK Investigational Site | Tokyo | 104-0031 | Japan |
| GSK Investigational Site | Tokyo | 143-0015 | Japan |
| GSK Investigational Site | Tokyo | 160-0008 | Japan |
| GSK Investigational Site | Częstochowa | 42-217 | Poland |
| GSK Investigational Site | Gdynia | 81-338 | Poland |
| GSK Investigational Site | Katowice | 40-081 | Poland |
| GSK Investigational Site | Katowice | 40-282 | Poland |
| GSK Investigational Site | Katowice | 40-648 | Poland |
| GSK Investigational Site | Katowice | 40-749 | Poland |
| GSK Investigational Site | Skorzewo | 60-185 | Poland |
| GSK Investigational Site | Sochaczew | 96-500 | Poland |
| GSK Investigational Site | Warsaw | 02-117 | Poland |
| GSK Investigational Site | Cape Town | 7530 | South Africa |
| GSK Investigational Site | Johannesburg | 2196 | South Africa |
| GSK Investigational Site | KwaDukuza | 4450 | South Africa |
| GSK Investigational Site | Pretoria | 0184 | South Africa |
| GSK Investigational Site | Somerset West | 7130 | South Africa |
| GSK Investigational Site | Bucheon-si | 422711 | South Korea |
| GSK Investigational Site | Daejeon | 35233 | South Korea |
| GSK Investigational Site | Seoul | 120-752 | South Korea |
| GSK Investigational Site | Seoul | 136-705 | South Korea |
| GSK Investigational Site | Seoul | 137-701 | South Korea |
| GSK Investigational Site | Seoul | South Korea |
| GSK Investigational Site | A Coruña | 15006 | Spain |
| GSK Investigational Site | Barcelona | 08023 | Spain |
| GSK Investigational Site | Málaga | 29010 | Spain |
| GSK Investigational Site | Palma de Mallorca | 07120 | Spain |
| GSK Investigational Site | San SebastiAn de Los Rey | 28702 | Spain |
| GSK Investigational Site | Torrevieja Alicante | 3186 | Spain |
| GSK Investigational Site | Cannock | WS11 0BN | United Kingdom |
| GSK Investigational Site | Liverpool | L9 7AL | United Kingdom |
| GSK Investigational Site | Teesside | TS17 6EW | United Kingdom |
| GSK Investigational Site | West Yorkshire | LS10 1DU | United Kingdom |
| FG002 | GSK3858279 360 mg | Participants received GSK3858279 SC injection 360 mg once per week for 12 weeks. |
| Full Analysis Set | Full Analysis Set included all randomized participants who received at least one dose of study intervention. |
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| COMPLETED |
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| NOT COMPLETED |
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The analysis was performed on the Full Analysis Set (FAS) set that included all randomized participants who received at least one dose of study intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received matching placebo subcutaneous (SC) injection once per week for 12 weeks. |
| BG001 | GSK3858279 60 mg | Participants received GSK3858279 SC injection 60 mg once per week for 12 weeks. |
| BG002 | GSK3858279 360 mg | Participants received GSK3858279 SC injection 360 mg once per week for 12 weeks. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| 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 | [1] The 'All Other Races' category (American Indian or Alaska Native, Black or African American, Asian, Multiple, Not Reported and Unknown) are combined into one category to maintain participant confidentiality and privacy. | Number | Participants |
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| 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 the Weekly Average of Average Daily Pain Score at Week 12, Assessed on the Numeric Rating Scale (NRS) | The change from baseline (CFB) in the weekly average of the average daily pain score at Week 12 was assessed using Numeric Rating Scale (NRS). Participants recorded their average daily pain response daily using a Brief Pain Inventory Item 5. It is a single item designed for self-reporting average pain score for past 24 hours. Participants were asked to mark their average pain intensity daily, using the NRS, on an 11-point scale (0 = no pain, 10 = worst pain imaginable). The weekly average was computed as weekly average of the average daily scores (range: 0-10), where higher scores indicate more severe pain. A negative CFB indicates pain improvement. Baseline was defined as the average score over the 7 days before dosing (Day -7 to -1). Posterior mean CFB and the 95% credible interval were derived using a Bayesian mixed model repeated measures analysis. The data presented as "Mean" refers to the 'posterior mean' and "95% confidence interval" to '95% credible interval'. | The analysis was performed on the Full Analysis Set population that included all randomized participants who received at least one dose of study intervention. Number of participants with analyzable outcome (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 a Scale | Baseline (Day -7 to Day -1) and Week 12 |
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| Secondary | Number of Participants With Adverse Events (AEs), Serious AE (SAEs) and AEs of Special Interest (AESI) | Adverse events, 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 SAE. AESIs of the study drug includes serious and opportunistic infections, tuberculosis (TB), serious hypersensitivity reactions and Injection site reactions. | This analysis was performed on Safety Set which included all participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | Up to 27 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 (NCI-CTCAE) | The laboratory measurements included hematology and clinical chemistry. The parameters evaluated were Eosinophils, Hemoglobin, White blood cell, Lymphocyte count, Neutrophil count and Platelet count, Alanine aminotransferase, Alkaline phosphatase, Aspartate aminotransferase, Blood bilirubin, Hypercalcemia, Hypocalcemia, Cholesterol, Creatine Phosphokinase, Creatinine, Gamma Glutamyl Transferase (GGT), Hypoglycemia, Hyperkalemia, Hypernatremia and Hypertriglyceridemia. Worst case grade (G) increase from baseline grade was evaluated for all the laboratory tests that were gradable by National Cancer Institute Common Terminology Criteria (NCI CTCAE). Data is presented for only those parameters for which participants had worst case >= Grade 3 increase from Baseline. | This analysis was performed on Safety Set which included all participants who received at least 1 dose of study treatment. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for specified time points. | Posted | Count of Participants | Participants | Up to 27 weeks |
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| Secondary | Maximum Concentration (Cmax) of GSK3858279 | Blood samples were collected for the determination of serum concentrations of GSK3858279 from which pharmacokinetic (PK) parameters were determined. Cmax was predicted from the population PK model fitted to GSK3859279 serum concentration time data collected at the indicated time points for PK analysis. | This analysis was performed on Pharmacokinetic (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 [NQ] 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 | Nanogram per milliliter (ng/mL) | Pre-dose, Week 1, Week 4, Week 7, Week 8, Week 11, Week 12, Week 16, Week 20 and Week 27 post dose |
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| Secondary | Time to Maximum Concentration (Tmax) of GSK3858279 | Blood samples were collected for the determination of serum concentrations of GSK3858279 from which PK parameters were determined. Tmax was 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 Pharmacokinetic (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 [NQ] 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, Week 1, Week 4, Week 7, Week 8, Week 11, Week 12, Week 16, Week 20 and Week 27 post dose |
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| Secondary | Trough Concentration at the End of the Dosing Interval (Ctau) of GSK3858279 | Blood samples were collected for the determination of serum concentrations of GSK3858279 from which PK parameters were determined. Ctau is defined as the lowest concentration reached by a drug before the next dose is administered. Ctau was predicted from the population PK model fitted to GSK3859279 serum concentration time data collected at the indicated time points for PK analysis. | This analysis was performed on Pharmacokinetic (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 [NQ] 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 | Nanogram per milliliter (ng/mL) | Pre-dose, Week 1, Week 4, Week 7, Week 8, Week 11, Week 12, Week 16, Week 20 and Week 27 post dose |
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| Secondary | Average Concentration Over a Dosing Interval (Cavg) of GSK3858279 | Blood samples were collected for the determination of serum concentrations of GSK3858279 from which PK parameters were determined. Cavg is the average concentration over the dosing interval (weekly). Cavg was predicted from the population PK model fitted to GSK3859279 serum concentration time data collected at the indicated time points for PK analysis. | This analysis was performed on Pharmacokinetic (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 [NQ] 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 | Nanogram per milliliter (ng/mL) | Pre-dose, Week 1, Week 4, Week 7, Week 8, Week 11, Week 12, Week 16, Week 20 and Week 27 post dose |
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| Secondary | Area Under the Time-Concentration Curve (AUC) Over the Dosing Interval (AUC[0-Tau]) of GSK3858279 | Blood samples were collected for the determination of serum concentrations of GSK3858279 from which PK parameters were determined. AUC(0-tau) was predicted from the population model fitted to GSK3859279 serum concentration time data collected at the indicated time points for PK analysis. | This analysis was performed on Pharmacokinetic (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 [NQ] 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*Nanogram per milliliter (Day*ng/mL) | Pre-dose, Week 1, Week 4, Week 7, Week 8, Week 11, Week 12, Week 16, Week 20 and Week 27 post dose |
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| Secondary | Change From Baseline in the Short-Form Mcgill Pain Questionnaire Total Score Over Time | The McGill pain questionnaire Short Form 2 is a 22-item questionnaire total score, which evaluated multi-dimensional pain over time. The questionnaire consists of 22 different descriptors of pain, and each item is rated based on a 0-10 pain intensity scale with 0 indicating no pain and 10 as worst possible pain. The total score was calculated as the mean of all item ratings. Higher scores indicate more severe pain. Baseline is defined as the last assessment prior to the first dose with a non-missing value, including those from unscheduled visits. Posterior mean change from baseline, 95 percent (%) credible interval (CI) was derived using Bayesian mixed model repeated measures. The data presented as 'Mean' refers to 'posterior mean' and '95% confidence interval' refers to '95% credible intervals'. | The analysis was performed on the Full Analysis Set population that included all randomized participants who received at least one dose of study intervention. Number of participants with analyzable outcome (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 a Scale | Baseline (Day1), Week 2, Week 4, Week 8 and Week 12 |
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| Secondary | Change From Baseline in the Weekly Average of Average Daily Pain Score Over Time, Assessed on the NRS | The change from baseline (CFB) in the weekly average of the average daily pain score at indicated time points was assessed using NRS. Participants recorded their average daily pain response daily using a Brief Pain Inventory Item 5. It is a single item designed for self-reporting average pain score for past 24 hours. Participants were asked to mark their average pain intensity daily, using the NRS, on an 11-point scale (0 = no pain, 10 = worst pain imaginable). The weekly average was computed as weekly average of the average daily scores (range: 0-10), where higher scores indicate more severe pain. A negative CFB indicates pain improvement. Baseline was defined as the average score over the 7 days before dosing (Day - 7 to -1). Posterior mean CFB and the 95% credible interval were derived using a Bayesian mixed model repeated measures analysis. The data presented as 'Mean' refers to the 'posterior mean' and '95% confidence interval' to the '95% credible interval'. | The analysis was performed on the Full Analysis Set population that included all randomized participants who received at least one dose of study intervention. Number of participants with analyzable outcome (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 a Scale | Baseline (Day -7 to Day -1), Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12 |
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| Secondary | Proportion of Participants With Greater Than or Equal To (>=) 30 Percentage (%) Reduction From Baseline in the Weekly Average of Average Daily Pain Intensity at Week 12, Assessed on the NRS | The proportion of participants who achieved >=30 percentage reduction from Baseline (responders) in the weekly average of the average daily pain score at Week 12 as measured by NRS is reported. Participants were instructed to assess their average daily pain daily, and to record the response in a Brief Pain Inventory item 5. It is a single item designed to capture information on the self- reported average pain score over the past 24 hours. Participants were asked to mark their pain- intensity daily, using the NRS, on an 11- point scale (0-10), with 0 = no pain, and 10 = worst pain imaginable. The weekly average was computed as weekly average of the average daily scores (range: 0-10), where higher scores indicate more severe pain. The data is presented for proportion of responders where 'Mean' refers to 'posterior mean proportion' and '95% confidence interval' refers to '95% credible interval'. | The analysis was performed on the Full Analysis Set (FAS) set that included all randomized participants who received at least one dose of study intervention. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for specified time points. | Posted | Mean | 95% Confidence Interval | Proportion of participants | At Week 12 |
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| Secondary | Proportion of Participants With Greater Than or Equal To >= 50 % Reduction From Baseline in the Weekly Average of Average Daily Pain Score at Week 12, Assessed on the NRS | The proportion of participants who achieved >=50 percentage reduction from Baseline (responders) in the weekly average of the average daily pain score at Week 12 as measured by NRS is reported. Participants were instructed to assess their average daily pain daily, and to record the response in a Brief Pain Inventory item 5. It is a single item designed to capture information on the self- reported average pain score over the past 24 hours. Participants were asked to mark their pain- intensity daily, using the NRS, on an 11- point scale (0-10), with 0 = no pain, and 10 = worst pain imaginable. The weekly average was computed as weekly average of the average daily scores (range: 0-10), where higher scores indicate more severe pain. The data is presented for proportion of responders where 'Mean' refers to 'posterior mean proportion' and '95% confidence interval' refers to '95% credible interval'. | The analysis was performed on the Full Analysis Set (FAS) set that included all randomized participants who received at least one dose of study intervention. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for specified time points. | Posted | Mean | 95% Confidence Interval | Proportion of participants | At Week 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 27.
Safety set included all randomized participants who took at least 1 dose of study intervention. Participants were analyzed according to the treatment they actually received.
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 12 weeks. | 0 | 48 | 4 | 48 | 11 | 48 |
| EG001 | GSK3858279 60 Milligram (mg) Weekly | Participants received GSK3858279 subcutaneous (SC) injection 60 mg once per week for 12 weeks. | 0 | 48 | 2 | 48 | 9 | 48 |
| EG002 | GSK3858279 360 mg Weekly | Participants received GSK3858279 SC injection 360 mg once per week for 12 weeks. | 0 | 48 | 0 | 48 | 10 | 48 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina unstable | Cardiac disorders | MedDRA 28 | Systematic Assessment |
| |
| Cat scratch disease | Infections and infestations | MedDRA 28 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 28 | Systematic Assessment |
| |
| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 28 | Systematic Assessment |
| |
| Hemianopia | Nervous system disorders | MedDRA 28 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 28 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 28 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site haemorrhage | General disorders | MedDRA 28 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 28 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 28 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 28 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 28 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 28 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 28 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 28 | 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 not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 8664357343 | GSKClinicalSupportHD@gsk.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 30, 2025 | Oct 7, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| D003920 | Diabetes Mellitus |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| Male |
|
| American Indian or Alaska Native |
|
| Asian |
|
| Black or African American |
|
| Mixed race |
|
| Not reported |
|
| Unknown |
|
| Posterior Mean Difference |
| -0.22 |
| 2-Sided |
| 95 |
| -1.04 |
| 0.61 |
Posterior mean difference with 95% credible interval is reported using Bayesian mixed model repeated measures analysis. |
| 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. |
|
|
Participants received GSK3858279 SC injection 60 milligram (mg) once per week for 12 weeks. |
| OG002 | GSK3858279 360 mg | Participants received GSK3858279 SC injection 360 mg once per week for 12 weeks. |
|
|
| Participants |
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Counts |
|---|
| Participants |
|
|
Participants received GSK3858279 SC injection 60 milligram (mg) once per week for 12 weeks. |
| OG002 | GSK3858279 360 mg | Participants received GSK3858279 SC injection 360 mg once per week for 12 weeks. |
|
|
| OG001 | GSK3858279 60 mg | Participants received GSK3858279 SC injection 60 milligram (mg) once per week for 12 weeks. |
| OG002 | GSK3858279 360 mg | Participants received GSK3858279 SC injection 360 mg once per week for 12 weeks. |
|
|
| OG001 | GSK3858279 60 mg | Participants received GSK3858279 SC injection 60 milligram (mg) once per week for 12 weeks. |
| OG002 | GSK3858279 360 mg | Participants received GSK3858279 SC injection 360 mg once per week for 12 weeks. |
|
|
| OG001 | GSK3858279 60 mg | Participants received GSK3858279 SC injection 60 milligram (mg) once per week for 12 weeks. |
| OG002 | GSK3858279 360 mg | Participants received GSK3858279 SC injection 360 mg once per week for 12 weeks. |
|
|