A Study to Evaluate the Efficacy, Safety and Tolerability of MIV-711 in Osteoarthritis Patients

Medivir244 enrolled

Overview

This is a multicentre, randomised, placebo-controlled, double-blind, three-arm parallel, Phase IIa study to evaluate the efficacy, safety and tolerability of MIV-711 in patients with knee osteoarthritis (OA).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

244

Conditions

Osteoarthritis, Knee

Interventions

MIV-711DRUG

MIV-711 administered orally once daily

PlaceboDRUG

Placebo manufactured to mimic MIV-711 capsule.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Current average knee pain, defined as pain in either knee, within 1 week before visit 1, for which the patient gives a severity score of ≥4, \<10 on a 0-10 NRS (Numeric Rating Scale). * Inclusive of 40-80 years old. * Diagnosis of primary knee osteoarthritis Exclusion Criteria: * The presence of any inflammatory arthritis * Any generalized pain condition that may interfere with the evaluation of the target knee pain (e.g., fibromyalgia) as judged by the investigator. * Any clinically severe or significant uncontrolled concurrent illness, which, in the opinion of the Investigator, would impair ability to give informed consent or take part in or complete this clinical study. * Known or suspected intolerance or hypersensitivity to the investigational product, closely related compounds, or any of the stated ingredients.

Locations (6)

MC Comac Medical

Sofia, Bulgaria

LCC ARENSIA Exploratory Medicine

Tbilisi, Georgia

PAREXEL Berlin Early Phase Clinical Unit

Berlin, Germany

LCC ARENSIA Exploratory Medicine

Chisinau, Moldova

Outcomes

Primary Outcomes

Numeric Rating Scale (NRS) Average Target Knee Pain Score at Week 26

Change from Visit 2 (Baseline) to Visit 8 (Week 26) in NRS average target knee pain score. NRS (Numeric rating scale) ranges from 0 indicating -"no pain", to 10 indicating - "pain as bad as it could be".

Time frame: baseline and 26 weeks

Secondary Outcomes

Magnetic Resonance Imaging (MRI) Bone Area of the Target Knee at Week 26

Change from Visit 2 (Baseline) to Visit 8 (Week 26) in MRI (Magnetic Resonance Imaging;) bone area of the target knee in mm\^2.

Time frame: baseline and 26 weeks

Magnetic Resonance Imaging (MRI) of Cartilage Thickness (Femur) at Week 26

Change from Visit 2 (baseline) to Visit 8 (week 26) in MRI cartilage thickness in the Central Medial Femur Region of the target knee in mm.

Time frame: baseline and 26 weeks

Normalised Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) Pain Score

Change from Visit 2 (Baseline) to Visit 8 (Week 26) in normalised WOMAC pain score. The WOMAC responses are scored using an 11-point NRS where 0=none and 10=extreme. There are 5 questions in the WOMAC pain scale which is summed up for the total WOMAC score, leading to a range of 0 to 50. The total WOMAC pain score has been standardised to a scale with a range from 0 to 100 (where 100 is extreme pain): \- Normalised WOMAC pain score = Total WOMAC pain score multiplicated with 2.

Time frame: baseline and 26 weeks

Normalised Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) Difficulty Score

Change from Visit 2 (Baseline) to Visit 8 (Week 26) in normalised WOMAC difficulty score. The WOMAC responses are scored using an 11-point NRS where 0=none and 10=extreme. There are 17 questions in the WOMAC difficulty scale which is summed up for the total WOMAC difficulty score, leading to a range of 0 to 170. The total WOMAC difficulty score has been standardised to a scale with a range from 0 to 100 (where 100 is extreme pain): \- Normalised WOMAC difficulty score = Total WOMAC difficulty score divided with 1.7

Data from ClinicalTrials.gov

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