A Phase IIa Study of MIV-711 in Knee Joint Osteoarthritis
Research type
Research Study
Full title
A Randomised, Double-blind Placebo-controlled Phase IIa Study to Evaluate Efficacy, Safety and Tolerability of MIV-711 in Knee Joint Osteoarthritis
IRAS ID
191244
Contact name
Charlotte Pai
Contact email
Sponsor organisation
Medivir AB
Eudract number
2015-003230-26
Duration of Study in the UK
1 years, 2 months, 31 days
Research summary
Osteoarthritis (OA) is a condition of progressive breakdown of one or more joints. The breakdown, of the joints, comprises both cartilage and underlying bone. Gradually increasing joint pain and decreasing functionality are the most important symptoms of this process. OA occurs most often in the weight bearing joints like the hips and knees, but can occur wherever there's a cartilage cushioned joint.
The ongoing degenerative nature of OA means that it will get worse over time unless there's some way to stop whatever caused the initial wear and tear of the joint(s).
Current treatments for OA are aimed at controlling pain and maintaining function. All major current guidelines recommend a range of drug and non-drug therapies, which include:
• Patient education
• Heat and cold
• Weight loss
• Exercise
• Physical therapy
• Occupational therapy
• Unloading (reducing or redistributing weight using devices or surgery) in joints (eg, knee, hip)
• Acetaminophen
• Oral Nonsteroidal anti-inflammatory drugs (NSAIDs)
• Topical NSAIDs
• Tramadol
• Intra-articular corticosteroid injectionsOther than surgery, there are no current safe, long-term, effective pain-relieving treatments for established OA. 70% of people with OA report to being in constant pain and 12.5% live with daily unbearable pain. This highlights the need for safe and effective drug treatment alternatives that target and modifies the OA disease process by positively affecting the joint’s bone and or cartilage components.
The study medication MIV-711 selectively inhibits cathepsin K, an enzyme that helps specific bone digesting cells that are thought to assist in the joint degeneration of OA. Cathepsin K levels are increased in joint tissue from OA patients and cathepsin K inhibitors can prevent OA joint breakdown based on results from animal studies.The aim of this study is to assess the effect of MIV-711 on knee pain, as measured by an 11-point self-rated scale in patients with knee OA, as well as the effects on joint structure as measured with magnetic resonance imaging (MRI).
A total of 240 patients with knee OA will be enrolled at six sites in: United Kingdom, Germany, Bulgaria, Georgia, Moldova and Romania.Sponsor: Medivir AB, Stockholm, Sweden
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
16/NW/0036
Date of REC Opinion
22 Mar 2016
REC opinion
Further Information Favourable Opinion