D5680C00003 - Painful Osteoarthritis of the Knee
Research type
Research Study
Full title
A Randomised, Double-blind, Placebo-controlled, Dose-response Study of the Efficacy and Safety of MEDI7352 in Subjects with Painful Osteoarthritis of the Knee
IRAS ID
287992
Contact name
Philip Conaghan
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2020-003797-51
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 8 months, 26 days
Research summary
MEDI7352 is an investigational drug that is being studied by AstraZeneca for use as a potential treatment for chronic pain associated with osteoarthritis (OA) of the knee.
This research study is for participants 18 to 80 years of age (inclusive) with moderate-to-severe chronic pain of the knee during the previous 3 months or longer, caused by OA, and not adequately controlled by standard-of-care treatments.
To learn about MEDI7352, it will be compared with a placebo. A placebo looks like the study drug but does not contain the active ingredient found in the investigational drug. A placebo is used to check that any effects seen in people taking part in the study are because of the investigational drug itself.
The main purpose of this study is to look at whether the investigational drug reduces pain in participants with painful OA of the knee. This will involve measuring pain levels experienced by the participants in the study.
The study will also explore how safe the investigational drug is, how the body handles taking the investigational drug (tolerability), find out how much of the investigational drug enters the blood stream after it is given and how its levels change over time (pharmacokinetics), and whether the body’s defence system (the immune system) reacts to the investigational drug (immunogenicity).
Approximately 300 people worldwide will take part in this study.
The study consists of a screening period of up to 45 days, a 12-week treatment period, and a 20-week follow-up period.
REC name
London - Chelsea Research Ethics Committee
REC reference
20/LO/1100
Date of REC Opinion
4 Jan 2021
REC opinion
Further Information Favourable Opinion