A Study of the Efficacy and Safety of MEDI7352 in Subjects With Painful Osteoarthritis of the Knee
A Study of the Efficacy and Safety of MEDI7352 in Subjects With Painful Osteoarthritis of the Knee
This is a Phase 2b randomised, double-blind, placebo-controlled, dose-response study in
 subjects with painful osteoarthritis (OA) of the knee. The study will assess the safety and
 efficacy of multiple doses of MEDI7352 compared to placebo, as well as the pharmacokinetics,
 pharmacodynamics and immunogenicity of MEDI7352 in subjects with moderate to severe chronic
 pain persistent for 3 months or more not adequately controlled by standard of care
 treatments.
Inclusion Criteria:

 1. Participants must understand the nature of the study and must give signed and dated
 written informed consent prior to the initiation of any study procedures, which
 includes compliance with the requirements and restrictions listed in the informed
 consent form (ICF) and in this protocol.

 2. For participants participating in the optional genetic research, a separate signed and
 dated optional genetic research ICF must be provided prior to collection of samples
 for optional genetic research that supports the Genomics Initiative. If a participant
 declines to participate in the genetic research, this will have no influence on the
 ability of a participant to participate in the study.

 3. The participant should be willing and able to understand and comply with all
 protocol-specified restrictions and procedures and be able to use an electronic
 patient-reported outcome (ePRO) device as judged by the investigator.

 4. The participant must be considered likely to comply with the study protocol and to
 have a high probability of completing the study, as judged by the investigator.

 5. The participant must be willing and able to discontinue all analgesic therapy with
 NSAID or COX-2 inhibitors from the start of the washout period until the end of the FU
 period. This includes over-the-counter (OTC) pain medications and topical analgesics
 that contain an NSAID or COX-2 inhibitor. There are additional restrictions for
 medications use during the different periods of the clinical study.

 Exclusion Criteria:

 1. Requires current treatment with another biologic therapeutic agent, DMARD, or other
 immunosuppressants

 2. Previously received any form of anti-NGF, anti-TNF, or other biological DMARDs
 (including but not limited to golimumab, certolizumab, infliximab, adalimumab
 etanercept, rituximab, abatacept, tocilizumab, and tofacitinib) for 12 months prior to
 screening or received other immunosuppressants for 6 months prior to screening

 3. Currently receiving strong opioids for any indication

 4. Participation in another clinical study with an IP or device within 60 days or 5
 half-lives, whichever is longer, prior to screening

 5. Plasma donation within 28 days of screening or any blood donation or blood loss > 50
 mL within 2 months of screening

 6. Previous allogeneic bone marrow or stem cell transplant

 7. Received nonleukocyte-depleted whole blood transfusion within 120 days of the genetic
 research sample collection, if participating in the optional genetic research

 8. Involvement in the planning and/or conduct of the study.