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

An Open-Label, One-Arm Phase II Extension Study to Evaluate Safety and Tolerability of MIV-711 in Patients With Knee Joint Osteoarthritis

This is a multicentre, open-label, one-arm Phase II extension study to evaluate the safety and tolerability of MIV-711 in patients with knee joint osteoarthritis (OA).

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 50
• 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 81 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

- Previously enrolled in the MIV-711-201 study including completion of Visit 8 either by

• Receiving MIV-711 200 mg and had non-significant clinical worsening on the primary endpoint as defined by a Numeric Rating Scale (NRS) increase of ≤2 OR by
• Receiving placebo and had a clinically significant worsening on the primary endpoint as defined by a NRS increase of ≥2

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: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: MIV-711; MIV-711 for a total of 26 weeks	Drug: MIV-711; MIV-711 administered orally once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Tolerability of MIV-711 in Osteoarthritis (OA) Patients	Number of Participants with Treatment Emergent Adverse Events (TEAEs); Number of Participants with Serious Adverse Events (SAEs); Number of Participants with TEAEs related to treatment; Number of Participants with mild TEAEs; Number of Participants with moderate TEAEs; Number of Participants with severe TEAEs; Number of Participants with TEAEs leading to early discontinuation	Group A: 0-56 weeks; Group B: 0-30 weeks

Collaborators and Investigators

• Sponsor: Medivir

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2016
• Primary Completion (ACTUAL): November 28, 2017
• Study Completion (ACTUAL): November 28, 2017

Study Registration Dates

• First Submitted: December 22, 2016
• First Submitted That Met QC Criteria: January 26, 2017
• First Posted (ESTIMATE): January 31, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 18, 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-711-202

Plan for Individual participant data (IPD)

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