A Study to Evaluate Efficacy and Safety of GSK3858279 in Diabetic Peripheral Neuropathic Pain (NEPTUNE-17)
Pain
About this trial
This is an interventional treatment trial for Pain focused on measuring Diabetes, Neuropathic pain, Diabetic Peripheral Neuropathic Pain (DPNP), 214221, GSK3858279, Efficacy, Safety, Pharmacokinetics, Tolerability
Eligibility Criteria
Inclusion Criteria: Participant must be 18-75 years of age inclusive, at the time of signing the informed consent. 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: History or presence of cardiovascular, renal, gastrointestinal, lymphatic disorders which in the opinion of the investigator would interfere with the study procedures and/or assessments. 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.
Sites / Locations
- GSK Investigational SiteRecruiting
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Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
GSK3858279 Dose 1
GSK3858279 Dose 2
Placebo
Participants will receive GSK3858279 dose 1.
Participants will receive GSK3858279 dose 2.
Participants will receive placebo.