Safety and efficacy of GSK3858279 in Diabetic Peripheral Neuropathic Pain

• Research type

  Research Study

• Full title

  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) / NEPTUNE-17

• IRAS ID

  1006266

• Contact name

  Yulia Green

• Contact email

  yulia.x.green@gsk.com

• Sponsor organisation

  GlaxoSmithKline Research & Development Limited

• Eudract number

  2022-502313-28

• Research summary

  Diabetic peripheral neuropathy is a common long-term complication for many individuals with diabetes. Diabetic peripheral neuropathy is the damage to nerves that can cause abnormal sensations such as prickling, burning, pain or numbness, weakness in the arms, hands, legs, and/or feet.
  This study will test a new drug, GSK3858279, which is a monoclonal antibody. Previous research has shown that GSK3858279 blocks the activity of a protein called CCL17 and may reduce pain. It is hoped that blocking CCL17 may reduce pain in individuals with diabetic peripheral neuropathy.
  The study will involve about 240 adult participants who are between 18-75 and experience Diabetic Peripheral Neuropathic Pain (DPNP). Around 17 of these participants will be in the UK. In the UK the study will be run from NHS hospitals and private research sites. The study will last for a period of up to 32 weeks which includes up to 5 weeks screening period, 12 week treatment period and a follow up period of 15 weeks. Participants will have 21 visits and one phone call over the course of the study.
  GSK3858279 is given by an injection under the skin. All study participants will be divided into 3 groups. Two groups will receive GSK3858279 and 1 group will receive placebo. The 2 groups receiving GSK3858279 will do so at two different doses. This study will test whether the study drug reduces pain in participants with DPNP. It will also look at the safety of GSK3858279, how the body reacts to it and how the body uses GSK3858279 at different doses. The study is sponsored by GlaxoSmithKline.
  Tests undertaken will include, but are not limited to:
  - blood tests
  - questionnaires on pain and quality of life
  - physical examination
  - urine tests

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  23/NW/0127

• Date of REC Opinion

  8 Sep 2023

• REC opinion

  Further Information Favourable Opinion