A Study of the Efficacy and Safety of MEDI7352 in Participants With Painful Osteoarthritis of the Knee
NCT ID: NCT04675034
Last Updated: 2025-02-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
345 participants
INTERVENTIONAL
2020-12-02
2023-08-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
Daily pain scores (as measured on an 11-point numerical rating scale \[NRS\]) recorded at the first screening visit and from Day -7 to Day -1 will be used be used to determine eligibility.
Participants will be randomised to one of 4 doses of MEDI7352 or placebo. Each participant will receive 6 doses of MEDI7352 or placebo during the treatment period.
After the end-of-treatment (EOT) visit at Week 12, participants will enter the FU period, which comprises 3 clinic visits (Weeks 18, 32, and 36) and 4 FU phone calls (Weeks 15, 21, 24, and 28). All participants who receive investigational product (IP) are expected to complete the FU period.
TREATMENT
QUADRUPLE
The IRT/RTSM will provide investigator(s) or appropriate study personnel with kit identification number to be allocated to participant at IP dosing visit.
Details for this will be described in IRT/RTSM user manual that will be provided to each centre.
All participants, investigators, and study personnel involved in conduct of the study will be blinded to treatment assignment. The unblinded study personnel (eg, site pharmacist) will not participate in study procedures or data analysis prior to unblinding of study data to all study-related personnel. Unblinded AstraZeneca personnel who are not otherwise involved in study will prepare data for review and interim analyses.
Study Groups
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MEDl7352 Dose 1
Participants received 6 doses of subcutaneous (SC) MEDl7352 Dose 1 injection once every 2 weeks (Q2W) during a 12-week parallel-group treatment period.
MEDI7352
Participants will receive SC injection of MEDI7352 as stated in arm description.
MEDl7352 Dose 2
Participants received 6 doses of SC MEDl7352 Dose 2 injection Q2W during a 12-week parallel-group treatment period.
MEDI7352
Participants will receive SC injection of MEDI7352 as stated in arm description.
MEDl7352 Dose 3
Participants received 6 doses of SC MEDl7352 Dose 3 injection Q2W during a 12-week parallel-group treatment period.
MEDI7352
Participants will receive SC injection of MEDI7352 as stated in arm description.
MEDl7352 Dose 4
Participants received 6 doses of SC MEDl7352 Dose 4 injection Q2W during a 12-week parallel-group treatment period.
MEDI7352
Participants will receive SC injection of MEDI7352 as stated in arm description.
Placebo
Participants received 6 doses of SC placebo injection matched to MEDl7352 Q2W during a 12-week parallel-group treatment period.
Placebo
Participants will receive SC injection of placebo as stated in arm description.
Interventions
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MEDI7352
Participants will receive SC injection of MEDI7352 as stated in arm description.
Placebo
Participants will receive SC injection of placebo as stated in arm description.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
80 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Frederiksberg, , Denmark
Research Site
Tallinn, , Estonia
Research Site
Tartu, , Estonia
Research Site
Bad Doberan, , Germany
Research Site
Leipzig, , Germany
Research Site
Munich, , Germany
Research Site
Bialystok, , Poland
Research Site
Bialystok, , Poland
Research Site
Bydgoszcz, , Poland
Research Site
Elblag, , Poland
Research Site
Gdynia, , Poland
Research Site
Lodz, , Poland
Research Site
Lublin, , Poland
Research Site
Poznan, , Poland
Research Site
Puławy, , Poland
Research Site
Staszów, , Poland
Research Site
Torun, , Poland
Research Site
Warsaw, , Poland
Research Site
Zamość, , Poland
Research Site
A Coruña, , Spain
Research Site
Barcelona, , Spain
Research Site
Madrid, , Spain
Research Site
Málaga, , Spain
Research Site
Sabadell, , Spain
Research Site
Santiago de Compostela, , Spain
Research Site
Santiago de Compostela, , Spain
Research Site
Santiago de Compostela-Coruña, , Spain
Research Site
Valencia, , Spain
Research Site
Corby, , United Kingdom
Research Site
Enfield, , United Kingdom
Research Site
Glasgow, , United Kingdom
Research Site
High Wycombe, , United Kingdom
Research Site
Leeds, , United Kingdom
Research Site
London, , United Kingdom
Research Site
Northwich, , United Kingdom
Research Site
Northwood, , United Kingdom
Research Site
Orpington, , United Kingdom
Research Site
Preston, , United Kingdom
Research Site
Rochdale, , United Kingdom
Research Site
Salford, , United Kingdom
Research Site
Shipley, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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2020-003797-51
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D5680C00003
Identifier Type: -
Identifier Source: org_study_id
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