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

Phase 2

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Drug: MIV-711

• Registration Number: NCT03037489
• Lead Sponsor: Medivir

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-12-22
• Study First Submitted QC: 2017-01-26
• Study First Posted: 2017-01-31
• Primary Completion: 2017-11-28
• Study Completion: 2017-11-28
• Results First Submitted: 2018-11-26
• Status Verified: 2019-03
• Results First Submitted QC: 2019-03-15
• Last Update Submitted: 2019-03-15
• Results First Posted: 2019-03-18
• Last Update Posted: 2019-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MIV-711	MIV-711	MIV-711 for a total of 26 weeks

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability of MIV-711 in Osteoarthritis (OA) Patients	Group A: 0-56 weeks; Group B: 0-30 weeks	1. Number of Participants with Treatment Emergent Adverse Events (TEAEs); 2. Number of Participants with Serious Adverse Events (SAEs); 3. Number of Participants with TEAEs related to treatment; 4. Number of Participants with mild TEAEs; 5. Number of Participants with moderate TEAEs; 6. Number of Participants with severe TEAEs; 7. Number of Participants with TEAEs leading to early discontinuation

Trial Locations

Locations (3)

MC Comac Medical; 🇧🇬 Sofia, Bulgaria

LCC ARENSIA Exploratory Medicine; 🇲🇩 Chisinau, Moldova, Republic of

PAREXEL Berlin Early Phase Clinical Unit; 🇩🇪 Berlin, Germany