A Study of the Efficacy and Safety of MEDI7352 in Subjects With Painful Osteoarthritis of the Knee

  • STATUS
    Recruiting
  • End date
    Apr 27, 2023
  • participants needed
    300
  • sponsor
    AstraZeneca
Updated on 16 October 2021

Summary

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.

Details
Condition Painful Osteoarthritis of the Knee
Treatment Placebo, MEDI7352
Clinical Study IdentifierNCT04675034
SponsorAstraZeneca
Last Modified on16 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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
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
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
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

Requires current treatment with another biologic therapeutic agent, DMARD, or other immunosuppressants
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
Currently receiving strong opioids for any indication
Participation in another clinical study with an IP or device within 60 days or 5 half-lives, whichever is longer, prior to screening
Plasma donation within 28 days of screening or any blood donation or blood loss > 50 mL within 2 months of screening
Previous allogeneic bone marrow or stem cell transplant
Received nonleukocyte-depleted whole blood transfusion within 120 days of the genetic research sample collection, if participating in the optional genetic research
Involvement in the planning and/or conduct of the study
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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