207804 In Part B, phase 1 study for oposteoarthritis of the knee.

• Research type

  Research Study

• Full title

  A two-part phase I randomized, double blind, placebo controlled study to evaluate safety, tolerability, pharmacokinetics and target engagement of single intravenous and subcutaneous doses of GSK3858279 in healthy participants and to evaluate the efficacy of repeat subcutaneous doses in participants with osteoarthritis of the knee

• IRAS ID

  251348

• Contact name

  Fernando Disala

• Contact email

  disala.x.fernando@gsk.com

• Sponsor organisation

  GSK

• Eudract number

  2017-004809-41

• ISRCTN Number

  ISRCTN12345789

• Clinicaltrials.gov Identifier

  NCT12345678

• Duration of Study in the UK

  1 years, 0 months, 30 days

• Research summary

  This is a two-part phase I study (this means that this is the first time the study drug will be given to humans) in healthy volunteers and participants with osteoarthritis (OA) of the knee.
  The study has 2 main parts (Part A and Part B) - Part B only is being submitted for approval.
  The purpose of part B of the study is to look at the following:
  • how safe and well tolerated the study drug is in people with OA of the knee
  • if the study drug can reduce levels of CCL17 in the blood
  • how well the study drug works following a single dose in reducing pain in people with OA of the knee
  • how the study drug works and what happens to it in the body (called pharmacokinetics [PK]).
  Up to 50 participants with OA of the knee will take part in this study. The dose of study drug that will be used in this part of the study will be determined in Part A. Participation in the study will last a maximum of 24 weeks. The study will involve a stay at the study centre overnight before receiving the study medication (Day -1) and an optional stay following dosing if preferred. The rest of the visits will be completed by out-patient visits to the study centre (approximately 10 visits).

  Lay summary of study results: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbUj3gyZenBVn6KyLiVmwDmcXCCoLEUT813xW1M9mRiR3x4ByfH6acK6PNjyok5St0Pd7-2FAq4FldyFJP-2BbAu1Zm78seyhsTywIMhh3eaW-2F5hWwFiT_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YI0bhk-2F-2BAAMQYzArS7Rp-2Fp2We8vmkXM4AV0agwUNaY4lLwJVHZ9zIbR1B-2F8irnjfu32mH0-2BqZGDiq4jXWrgqoYM26qOnelRRQzkje1r-2B6VMcFFRDvJmQOXXq3pd-2Fw0VXIADbznVhVp-2FWtXNcAny9MJxhv03VRSciMBBKKjr1CZqkw-3D-3D&data=05%7C01%7Criverside.rec%40hra.nhs.uk%7C3f65497e2edb467f4ea708dbe10abe92%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638351208483665540%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=1Mqi6TIvzqaOpiaZl7BChf9ZoBqPTosT6o%2FDfKJW3nc%3D&reserved=0

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  18/LO/1415

• Date of REC Opinion

  31 Oct 2018

• REC opinion

  Further Information Favourable Opinion