Study identifier:D5680C00003
ClinicalTrials.gov identifier:NCT04675034
EudraCT identifier:2020-003797-51
CTIS identifier:N/A
A Randomised, Double-blind, Placebo-controlled, Dose-response Study of the Efficacy and Safety of MEDI7352 in Subjects with Painful Osteoarthritis of the Knee
Painful osteoarthritis of the knee
Phase 2
No
MEDI7352
All
345
Interventional
18 Years - 80 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Feb 2025 by AstraZeneca
AstraZeneca
-
This is a Phase IIb randomised, double-blind, placebo-controlled, dose-response study in participants 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 participants with moderate to severe chronic pain persistent for 3 months or more not adequately controlled by standard of care treatments.
Location
Location
Tallinn, Estonia, 10117
Location
Tartu, Estonia, 50708
Location
Preston, United Kingdom, PR2 9QB
Location
Rochdale, United Kingdom, OL11 4AU
Location
Enfield, United Kingdom, EN3 4GS
Location
London, United Kingdom, EC2Y 8EA
Location
Leeds, United Kingdom, LS7 4SA
Location
Białystok, Poland, 15-351
Arms | Assigned Interventions |
---|---|
Experimental: 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. | 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 a 12-week parallel-group 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 a 12-week parallel-group 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 a 12-week parallel-group 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 a 12-week parallel-group treatment period. | Other: Placebo Participants will receive SC injection of placebo as stated in arm description. |
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