NCT02705625

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).

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
244

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2016

Shorter than P25 for phase_2

Geographic Reach
6 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 28, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 7, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 10, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2017

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

June 17, 2019

Completed
Last Updated

June 17, 2019

Status Verified

March 1, 2019

Enrollment Period

1.3 years

First QC Date

March 7, 2016

Results QC Date

May 22, 2018

Last Update Submit

March 15, 2019

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

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

    baseline and 26 weeks

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

    baseline and 26 weeks

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

    baseline and 26 weeks

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

    baseline and 26 weeks

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

    baseline and 26 weeks

  • +2 more secondary outcomes

Study Arms (3)

MIV-711:1

EXPERIMENTAL

MIV-711 for a total of 26 w

Drug: MIV-711

MIV-711:2

EXPERIMENTAL

MIV-711 for a total of 26 w

Drug: MIV-711

Placebo

PLACEBO COMPARATOR

Placebo for a total of 26 w

Drug: Placebo

Interventions

MIV-711DRUG

MIV-711 administered orally once daily

MIV-711:1MIV-711:2
PlaceboDRUG

Placebo manufactured to mimic MIV-711 capsule.

Placebo

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

MC Comac Medical

Sofia, Bulgaria

Location

LCC ARENSIA Exploratory Medicine

Tbilisi, Georgia

Location

PAREXEL Berlin Early Phase Clinical Unit

Berlin, Germany

Location

LCC ARENSIA Exploratory Medicine

Chisinau, Moldova

Location

SC ARENSIA Exploratory Medicine SRL

Bucharest, Romania

Location

University of Leeds, Leeds Institute of Rheumatic and Musculoskeletal Medicine

Leeds, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

MIV-711

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Results Point of Contact

Title
Linda Basse, Cheif Medical Officer
Organization
Medivir
linda.basse@medivir.com
+46 8 546 831 00

Study Officials

  • Philip Conaghan, Professor

    Leeds Institute of Rheumatic and Musculoskeletal Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2016

First Posted

March 10, 2016

Study Start

January 28, 2016

Primary Completion

May 23, 2017

Study Completion

May 23, 2017

Last Updated

June 17, 2019

Results First Posted

June 17, 2019

Record last verified: 2019-03

Locations

BU(1)GE(1)RO(1)MO(1)GB(1)DE(1)