An Open-Label, One-Arm Phase II Extension Study to ...

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

Spons or:

Clinical Re search Organization: Principal/Global Coordinating Inve s tigator

Sponsor Protocol No.: EudraCT No.: Study Drug Name: Development Phase: Date of Protocol:

Medivir AB Blasieholmsgatan 2, 111 48 Stockholm, Sweden

PAREXEL International (IRL) Limited, 70 Sir John Rogerson's Quay, Dublin 2, Ireland.

Prof. Philip Conaghan University of Leeds Leeds Institute of Rheumatic and Musculoskeletal Medicine Chapel Allerton Hospital Chapeltown Road Leeds LS7 4SA, United Kingdom

MIV-711-202

2016-001096-73 MIV-711

Phase II

01 July 2016

The study will be conducted according to the protocol and in compliance with Good Clinical Practice (GCP), with the Declaration of Helsinki [1] and with other applicable regulatory requirements.

CONFIDENTIAL

This document contains confidential information of Medivir AB. Do not copy or distribute without written permission from the Sponsor.

MEDIVIR MIV-711-202

Clinical Study Protocol CONFIDENTIAL

Declaration of the Investigator

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

All documentation for this study that is supplied to me and that has not been previously published will be kept in the strictest confidence. This documentation includes this study protocol, Investigator's Brochure, electronic Case Report Form (eCRF), Patient-Reported Outcomes (PRO), patient diaries and other scientific data.

The study will not be commenced without the prior written approval of a properly constituted Independent Ethics Committee (IEC). No changes will be made to the study protocol without the prior written approval of the Sponsor and the IEC, except where necessary to eliminate an immediate hazard to the patients.

I have read and understood and agree to abide by all the conditions and instructions contained in this protocol.

Responsible Investigator of the local study centre

Signature

Date

Name (block letters)

Title (block letters)

Institution (block letters)

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Final

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MEDIVIR MIV-711-202

Clinical Study Protocol CONFIDENTIAL

PROTOCOL SYNOPSIS

Title

Sponsor Study No. Phas e Spons or

Principal or Global Coordinating Inve s tigator

Study Centers

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

MIV-711-202 Phase II

Medivir AB Blasieholmsgatan 2, 111 48 Stockholm, Sweden

Prof. Philip Conaghan University of Leeds Leeds Institute of Rheumatic and Musculoskeletal Medicine Chapel Allerton Hospital Chapeltown Road, Leeds LS7 4SA, United Kingdom

Five sites distributed in 5 European countries.

1) PAREXEL Berlin Early Phase Clinical Unit, PAREXEL International GmbH, Spandauer Damm 130, 14050 Berlin, Germany

2) MC Comac Medical, 13 Urvich Str, 1612 Sofia, Bulgaria

3) LLC ARENSIA Exploratory Medicine, Research Institute of Clinical Medicine, 13a, Tevdore Mgvdeli Str. 0112 Tbilisi, Georgia

4) LLC ARENSIA Exploratory Medicine, Republican Clinical Hospital, 29 Testemitanu Str. 2025 Chisinau, Republic of Moldova

5) SC ARENSIA Exploratory Medicine SRL Spitalul Clinic Colentina, Sectia de Medicina Interna III, Sos. Stefan cel Mare Nr. 19-21, Sector 2 Bucharest 020125, Romania

Obje ctive

The primary objective is to assess the safety and tolerability of 200 mg MIV-711 q.d. over 52 (26+26) weeks in patients with symptomatic and radiographic knee osteoarthritis (OA).

De s ign

This is a multicentre, open-label, one-arm Phase II extension study to evaluate the safety and tolerability of MIV-711 for up to 52 (26+26) weeks in patients with knee joint OA. Patients to be enrolled will be selected from the patients in Study MIV-711-201 (a randomised, double-blind, placebo-controlled Phase IIa study to evaluate efficacy, safety and tolerability of MIV-711 in knee joint osteoarthritis).

Patients treated with 200 mg MIV-711 once daily (q.d.) in Study MIV-711-201 whose symptoms did not clinically significantly deteriorate as defined by a numeric rating scale (NRS) increase of FRPSDUHG WR %aseline will be offered to roll over for 26 weeks' extended treatment primarily evaluating longer term safety and tolerability. The 52 (26+26) weeks total treatment also allows for a more suitable treatment length for the exploratory study of any structural effects of MIV-711 on joint cartilage thickness. In this protocol, this population is referred to as Study Population A.

The second objective of this study is the exploratory assessment of the treatment effect in a

Final

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