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

A Randomised, Double-blind Placebo-controlled Phase IIa Study to Evaluate Efficacy, Safety and Tolerability of MIV-711 in Knee Joint Osteoarthritis

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 Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Drug: MIV-711; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 244
• Phase: Phase 2

Contacts and Locations

Study Locations

• Bulgaria
  • Sofia, Bulgaria
    • MC Comac Medical
• Georgia
  • Tbilisi, Georgia
    • LCC ARENSIA Exploratory Medicine
• Germany
  • Berlin, Germany
    • PAREXEL Berlin Early Phase Clinical Unit
• Moldova, Republic of
  • Chisinau, Moldova, Republic of
    • LCC ARENSIA Exploratory Medicine
• Romania
  • Bucharest, Romania
    • SC ARENSIA Exploratory Medicine SRL
• United Kingdom
  • Leeds, United Kingdom
    • University of Leeds, Leeds Institute of Rheumatic and Musculoskeletal Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MIV-711:1; MIV-711 for a total of 26 w	Drug: MIV-711; MIV-711 administered orally once daily
Experimental: MIV-711:2; MIV-711 for a total of 26 w	Drug: MIV-711; MIV-711 administered orally once daily
Placebo Comparator: Placebo; Placebo for a total of 26 w	Drug: Placebo; Placebo manufactured to mimic MIV-711 capsule.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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".	baseline and 26 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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	baseline and 26 weeks
Normalised Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Score	Change from Visit 2 (Baseline) to Visit 8 (Week 26) in normalised WOMAC stiffness score. The WOMAC responses are scored using an 11-point NRS where 0=none and 10=extreme. There are 2 questions in the WOMAC stiffness scale which is summed up for the total WOMAC stiffness score, leading to a range of 0 to 20. The total WOMAC stiffness score has been standardised to a scale with a range from 0 to 100 (where 100 is extreme pain): - Normalised WOMAC stiffness score = Total WOMAC stiffness score multiplicated with 5	baseline and 26 weeks
Serum C-terminal Telopeptide of Collagen Type I (CTX-I) at Week 26	Change from Visit 2 (baseline) to Visit 8 (week 26) in serum CTX-I, a biomarker for bone resorption.	baseline and 26 weeks
Creatinine Corrected Urine C-terminal Telopeptide of Collagen Type II (CTX-II) at Week 26	Change from Visit 2 (baseline) to Visit 8 (week 26) in creatinine corrected urine CTX-II, a biomarker for cartilage degradation.	baseline and 26 weeks

Collaborators and Investigators

• Sponsor: Medivir

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2016
• Primary Completion (Actual): May 23, 2017
• Study Completion (Actual): May 23, 2017

Study Registration Dates

• First Submitted: March 7, 2016
• First Submitted That Met QC Criteria: March 7, 2016
• First Posted (Estimate): March 10, 2016

Study Record Updates

• Last Update Posted (Actual): June 17, 2019
• Last Update Submitted That Met QC Criteria: March 15, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: MIV-711-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED