Chronic diabetic peripheral neuropathic pain
Conditions
Interventions
-GSK3858279(2 doses)
-Placebo
This study consists of 3 study arms (Placebo arm and GSK3858279 dose1~2 arms).
Sponsors
Okamasa Arisa
Eligibility
Sex/Gender
All
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline at Week 12 in weekly average of average daily knee pain intensity, assessed on the Numeric Rating Scale (NRS) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Occurrence of AEs, SAEs and AEs of Special Interest (AESIs) - Occurrence of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade >-3 hematological/clinical chemistry abnormalities - Maximum value (Cmax), time of Cmax (tmax), trough value (Ctau), average concentration (Cavg) and area under the curve over the dosing interval (AUC(0-tau)) after the last planned dose - Change from baseline in the Short-Form McGill Pain Questionnaire total score over time - Change from baseline in the weekly average of average daily pain intensity over time, assessed on the NRS - Occurrence of >-30% reduction from baseline in the weekly average of average daily pain intensity at Week 12, assessed on the NRS - Occurrence of >-50% reduction from baseline in the weekly average of average daily pain intensity at Week 12, assessed on the NRS | — |
Countries
Canada, China, France, Germany, Japan, Korea, Poland, South Africa, Spain, Turkey, United Kingdom, United States
Contacts
Public ContactArisa Okamasa
GlaxoSmithKline K.K.
Outcome results
None listed