A Study to Evaluate Efficacy and Safety of GSK3858279 in Diabetic Peripheral Neuropathic Pain
NCT ID: NCT05838755
Last Updated: 2025-11-21
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
147 participants
INTERVENTIONAL
2023-09-20
2025-02-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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GSK3858279 60 mg
Participants received GSK3858279 SC injection 60 milligram (mg) once per week for 12 weeks.
GSK3858279
GSK3858279 was administered
GSK3858279 360 mg
Participants received GSK3858279 SC injection 360 mg once per week for 12 weeks.
GSK3858279
GSK3858279 was administered
Placebo
Participants received matching placebo subcutaneous (SC) injection once per week for 12 weeks.
Placebo
Placebo was administered
Interventions
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GSK3858279
GSK3858279 was administered
Placebo
Placebo was administered
Eligibility Criteria
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Inclusion Criteria
* Type I or Type II diabetes with painful, distal, symmetrical, sensory motor neuropathy attributed to diabetes, of at least 6 months duration.
* A pain score ≥4 and less than or equal to (≤) 9 by the 11-point NRS (0-10) for average daily pain intensity over the past 24 hours at the screening visit.
* Body mass index (BMI) within the range 18-40 kilogram per meter square (kg/m\^2) (inclusive)
* Capable of giving signed informed consent.
Exclusion Criteria
* Participant has current painful peripheral neuropathy due to a cause other than diabetes (e.g. pernicious anemia, hypothyroidism, post-herpetic neuralgia).
* History of significant allergies to monoclonal antibodies.
* Current enrolment or past participation in a clinical study of an investigational medicinal product intervention within the last 30 days or 5 half-lives (whichever is longer) of signing consent.
* Participants who are unlikely to comply with the protocol (e.g. uncooperative attitude, inability to return for subsequent visits, inability to complete the eDiary daily etc.) and/or otherwise considered by the Investigator to be unlikely to complete the study.
18 Years
75 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Anniston, Alabama, United States
GSK Investigational Site
Surprise, Arizona, United States
GSK Investigational Site
Cerritos, California, United States
GSK Investigational Site
Lomita, California, United States
GSK Investigational Site
Largo, Florida, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
West Palm Beach, Florida, United States
GSK Investigational Site
Decatur, Georgia, United States
GSK Investigational Site
Chicago, Illinois, United States
GSK Investigational Site
Waltham, Massachusetts, United States
GSK Investigational Site
Williamsville, New York, United States
GSK Investigational Site
Huntersville, North Carolina, United States
GSK Investigational Site
Lancaster, South Carolina, United States
GSK Investigational Site
Cypress, Texas, United States
GSK Investigational Site
DeSoto, Texas, United States
GSK Investigational Site
Houston, Texas, United States
GSK Investigational Site
McAllen, Texas, United States
GSK Investigational Site
Bellevue, Washington, United States
GSK Investigational Site
New Westminster, British Columbia, Canada
GSK Investigational Site
Vancouver, British Columbia, Canada
GSK Investigational Site
Winnipeg, Manitoba, Canada
GSK Investigational Site
Toronto, Ontario, Canada
GSK Investigational Site
Toronto, Ontario, Canada
GSK Investigational Site
Beijing, , China
GSK Investigational Site
Guangzhou, , China
GSK Investigational Site
Harbin, , China
GSK Investigational Site
Luoyang, , China
GSK Investigational Site
Shanghai, , China
GSK Investigational Site
Wuhan, , China
GSK Investigational Site
Yueyang, , China
GSK Investigational Site
Corbeil-Essonnes, , France
GSK Investigational Site
Mulhouse, , France
GSK Investigational Site
Bad Homburg, , Germany
GSK Investigational Site
Mainz, , Germany
GSK Investigational Site
Münster, , Germany
GSK Investigational Site
Wallerfing, , Germany
GSK Investigational Site
Chiba, , Japan
GSK Investigational Site
Fukuoka, , Japan
GSK Investigational Site
Gunma, , Japan
GSK Investigational Site
Hokkaido, , Japan
GSK Investigational Site
Ibaraki, , Japan
GSK Investigational Site
Kanagawa, , Japan
GSK Investigational Site
Osaka, , Japan
GSK Investigational Site
Tochigi, , Japan
GSK Investigational Site
Tochigi, , Japan
GSK Investigational Site
Tochigi, , Japan
GSK Investigational Site
Tokyo, , Japan
GSK Investigational Site
Tokyo, , Japan
GSK Investigational Site
Tokyo, , Japan
GSK Investigational Site
Tokyo, , Japan
GSK Investigational Site
Częstochowa, , Poland
GSK Investigational Site
Gdynia, , Poland
GSK Investigational Site
Katowice, , Poland
GSK Investigational Site
Katowice, , Poland
GSK Investigational Site
Katowice, , Poland
GSK Investigational Site
Katowice, , Poland
GSK Investigational Site
Skorzewo, , Poland
GSK Investigational Site
Sochaczew, , Poland
GSK Investigational Site
Warsaw, , Poland
GSK Investigational Site
Cape Town, , South Africa
GSK Investigational Site
Johannesburg, , South Africa
GSK Investigational Site
KwaDukuza, , South Africa
GSK Investigational Site
Pretoria, , South Africa
GSK Investigational Site
Somerset West, , South Africa
GSK Investigational Site
Bucheon-si, , South Korea
GSK Investigational Site
Daejeon, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
A Coruña, , Spain
GSK Investigational Site
Barcelona, , Spain
GSK Investigational Site
Málaga, , Spain
GSK Investigational Site
Palma de Mallorca, , Spain
GSK Investigational Site
San SebastiAn de Los Rey, , Spain
GSK Investigational Site
Torrevieja Alicante, , Spain
GSK Investigational Site
Cannock, , United Kingdom
GSK Investigational Site
Liverpool, , United Kingdom
GSK Investigational Site
Teesside, , United Kingdom
GSK Investigational Site
West Yorkshire, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2022-502313-28-00
Identifier Type: OTHER
Identifier Source: secondary_id
214221
Identifier Type: -
Identifier Source: org_study_id
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