search
Back to results

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

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MIV-711
Placebo
Sponsored by
Medivir
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • MC Comac Medical
  • LCC ARENSIA Exploratory Medicine
  • PAREXEL Berlin Early Phase Clinical Unit
  • LCC ARENSIA Exploratory Medicine
  • SC ARENSIA Exploratory Medicine SRL
  • University of Leeds, Leeds Institute of Rheumatic and Musculoskeletal Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

MIV-711:1

MIV-711:2

Placebo

Arm Description

MIV-711 for a total of 26 w

MIV-711 for a total of 26 w

Placebo for a total of 26 w

Outcomes

Primary Outcome Measures

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".

Secondary Outcome Measures

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.
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.
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.
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
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
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.
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.

Full Information

First Posted
March 7, 2016
Last Updated
March 15, 2019
Sponsor
Medivir
search

1. Study Identification

Unique Protocol Identification Number
NCT02705625
Brief Title
A Study to Evaluate the Efficacy, Safety and Tolerability of MIV-711 in Osteoarthritis Patients
Official Title
A Randomised, Double-blind Placebo-controlled Phase IIa Study to Evaluate Efficacy, Safety and Tolerability of MIV-711 in Knee Joint Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
January 28, 2016 (Actual)
Primary Completion Date
May 23, 2017 (Actual)
Study Completion Date
May 23, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medivir

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
244 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MIV-711:1
Arm Type
Experimental
Arm Description
MIV-711 for a total of 26 w
Arm Title
MIV-711:2
Arm Type
Experimental
Arm Description
MIV-711 for a total of 26 w
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for a total of 26 w
Intervention Type
Drug
Intervention Name(s)
MIV-711
Intervention Description
MIV-711 administered orally once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo manufactured to mimic MIV-711 capsule.
Primary Outcome Measure Information:
Title
Numeric Rating Scale (NRS) Average Target Knee Pain Score at Week 26
Description
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 Outcome Measure Information:
Title
Magnetic Resonance Imaging (MRI) Bone Area of the Target Knee at Week 26
Description
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
Title
Magnetic Resonance Imaging (MRI) of Cartilage Thickness (Femur) at Week 26
Description
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
Title
Normalised Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) Pain Score
Description
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
Title
Normalised Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) Difficulty Score
Description
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
Time Frame
baseline and 26 weeks
Title
Normalised Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Score
Description
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
Time Frame
baseline and 26 weeks
Title
Serum C-terminal Telopeptide of Collagen Type I (CTX-I) at Week 26
Description
Change from Visit 2 (baseline) to Visit 8 (week 26) in serum CTX-I, a biomarker for bone resorption.
Time Frame
baseline and 26 weeks
Title
Creatinine Corrected Urine C-terminal Telopeptide of Collagen Type II (CTX-II) at Week 26
Description
Change from Visit 2 (baseline) to Visit 8 (week 26) in creatinine corrected urine CTX-II, a biomarker for cartilage degradation.
Time Frame
baseline and 26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Conaghan, Professor
Organizational Affiliation
Leeds Institute of Rheumatic and Musculoskeletal Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
MC Comac Medical
City
Sofia
Country
Bulgaria
Facility Name
LCC ARENSIA Exploratory Medicine
City
Tbilisi
Country
Georgia
Facility Name
PAREXEL Berlin Early Phase Clinical Unit
City
Berlin
Country
Germany
Facility Name
LCC ARENSIA Exploratory Medicine
City
Chisinau
Country
Moldova, Republic of
Facility Name
SC ARENSIA Exploratory Medicine SRL
City
Bucharest
Country
Romania
Facility Name
University of Leeds, Leeds Institute of Rheumatic and Musculoskeletal Medicine
City
Leeds
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs