A Study of the Efficacy and Safety of MEDI7352 in Participants with Painful Osteoarthritis of the Knee - BESPOKE

Study identifier:D5680C00003

ClinicalTrials.gov identifier:NCT04675034

EudraCT identifier:2020-003797-51

CTIS identifier:N/A

Study Complete

Official Title

A Randomised, Double-blind, Placebo-controlled, Dose-response Study of the Efficacy and Safety of MEDI7352 in Subjects with Painful Osteoarthritis of the Knee

Medical condition

Painful osteoarthritis of the knee

Phase

Phase 2

Healthy volunteers

Study drug

MEDI7352

Sex

All

Actual Enrollment

345

Study type

Interventional

Age

18 Years - 80 Years

Date

Study Start Date: 02 Dec 2020

Primary Completion Date: 16 Aug 2023

Study Completion Date: 16 Aug 2023

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Aug 2024 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

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 nonsteroidal anti-inflammatory drugs (NSAID) or cyclooxygenase-2 (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.

Exclusion Criteria

1 Requires current treatment with another biologic therapeutic agent, disease-modifying antirheumatic drug (DMARD), or other immunosuppressants.
2 Previously received any form of anti-nerve growth factor (NGF); received anti-tumour necrosis factors (TNFs) including but not limited to golimumab, certolizumab, infliximab, adalimumab, etanercept, or rituximab within 12 months prior to screening, or other biological DMARDs (including but not limited to abatacept, tocilizumab, and tofacitinib), or other immunosuppressants within 6 months prior to screening (with the exception of inhaled or topical corticosteroids).
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 > 500 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.

No locations available

Arms	Assigned Interventions
Experimental: MEDl7352 Dose 1 Participants received 6 doses of subcutaneous (SC) MEDl7352 Dose 1 injection once every 2 weeks (Q2W) during 12-week treatment period.	Drug: MEDI7352 Participants will receive SC injection of MEDI7352 as stated in arm description.
Experimental: MEDl7352 Dose 2 Participants received 6 doses of SC MEDl7352 Dose 2 injection Q2W during 12-week treatment period.	Drug: MEDI7352 Participants will receive SC injection of MEDI7352 as stated in arm description.
Experimental: MEDl7352 Dose 3 Participants received 6 doses of SC MEDl7352 Dose 3 injection Q2W during 12-week treatment period.	Drug: MEDI7352 Participants will receive SC injection of MEDI7352 as stated in arm description.
Experimental: MEDl7352 Dose 4 Participants received 6 doses of SC MEDl7352 Dose 4 injection Q2W during 12-week treatment period.	Drug: MEDI7352 Participants will receive SC injection of MEDI7352 as stated in arm description.
Placebo Comparator: Placebo Participants received 6 doses of SC placebo injection matched to MEDl7352 Q2W during 12-week treatment period.	Other: Placebo Participants will receive SC injection of placebo as stated in arm description.

Documents available

CSR Synopsis
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]