Comparison of single RTX-GRT7039 vs placebo injection for knee pain associated with osteoarthritis

• Research type

  Research Study

• Full title

  A randomized, double-blind, placebo-controlled, Phase III trial to evaluate the efficacy and safety of a single intra-articular injection of RTX-GRT7039 in adult subjects with pain associated with osteoarthritis of the knee.

• IRAS ID

  1005195

• Contact name

  Jessica Luppus

• Contact email

  regulatory.affairs@grunenthal.com

• Sponsor organisation

  Grünenthal GmbH

• Eudract number

  2021-005020-38

• Clinicaltrials.gov Identifier

  NCT05449132

• Research summary

  This research study is a double-blind (neither Doctor nor participant will know who is receiving the study drug), Phase III trial to evaluate the efficacy and safety of a single injection in the index knee (knee with the worst pain) of RTX-GRT7039 in adult participants with moderate to severe pain associated with osteoarthritis of the knee, and who are not getting adequate pain relief despite the usual standard of care treatment.
  The purpose of this study is to test the efficacy of an investigational study drug , RTX-GRT7039, on knee pain and to evaluate if RTX-GRT7039 is safe and well tolerated when compared to a placebo (looks like the study drug but contains no active medicine).
  Approximately 450 participants will be randomised to receive a single dose of either RTX-GRT7039 or placebo in a 1:1 ratio, with a safety follow-up duration of 52 weeks (approx. 1 year).
  
  The trial has 2 stages, the 'screening period' (when tests will be performed to confirm trial eligibility) and the 'treatment and follow-up period'. Participants who continue to the treatment period, in addition to continued standard of care treatment, will receive the study treatment or Placebo as an injection into their knee joint space in their 'index knee'.
  Study procedures will include: X-rays, MRI scans, blood and urine tests, ECGs, physical examinations and completion of questionnaires

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  22/SC/0194

• Date of REC Opinion

  29 Jul 2022

• REC opinion

  Further Information Favourable Opinion