A Study to Evaluate Efficacy and Safety of GSK3858279 in Diabetic Peripheral Neuropathic Pain

Launched by GLAXOSMITHKLINE · Apr 20, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called GSK3858279, which is being tested for its ability to help manage pain caused by diabetic peripheral neuropathic pain (DPNP). DPNP is a type of nerve pain that some people with diabetes experience, and this trial aims to find out if GSK3858279 can effectively reduce that pain. The study is being conducted at multiple locations and is designed to ensure that neither the participants nor the researchers know who is receiving the actual medication versus a placebo (a pill that looks the same but has no active medication).

To be eligible for this trial, participants must be between 18 and 75 years old, have been diagnosed with Type 1 or Type 2 diabetes, and experience moderate to severe pain from DPNP for at least six months. They also need to meet certain health criteria to ensure safety during the trial. Participants will receive regular check-ups and may be asked to keep a daily diary to track their pain levels and any side effects they may experience. This study is an important step in understanding how well GSK3858279 works and whether it is safe for people suffering from this type of pain.

Gender

ALL

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.