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Also known as MEDI7352 for Subcutaneous Injection
MEDI7352 · 2 trials · 1 indication
Change from baseline in weekly average of daily NRS pain score to Week 12 is reported. The NRS is an 11-point Likert scale used to assess pain, where participants were asked to describe their average pain in the target knee by identifying a number from 0 = "no pain" to 10 = "most severe pain imaginable over the previous 24 hours". This was recorded on a daily basis at approximately the same time every morning via electronic patient recorded outcome (ePRO) diary. A two-step multiple imputation procedure was used to address missing post-baseline scores.
To evaluate the safety and tolerability of MEDI7352 in healthy Japanese and Caucasian participants following multiple dosing by the SC route
| Arm | Type | Description |
|---|---|---|
| MEDl7352 Dose 1 | EXPERIMENTAL | Participants received 6 doses of subcutaneous (SC) MEDl7352 Dose 1 injection once every 2 weeks (Q2W) during a 12-week parallel-group treatment period. |
| MEDl7352 Dose 2 | EXPERIMENTAL | Participants received 6 doses of SC MEDl7352 Dose 2 injection Q2W during a 12-week parallel-group treatment period. |
| MEDl7352 Dose 3 | EXPERIMENTAL | Participants received 6 doses of SC MEDl7352 Dose 3 injection Q2W during a 12-week parallel-group treatment period. |
| MEDl7352 Dose 4 | EXPERIMENTAL | Participants received 6 doses of SC MEDl7352 Dose 4 injection Q2W during a 12-week parallel-group treatment period. |
| Placebo | PLACEBO_COMPARATOR | Participants received 6 doses of SC placebo injection matched to MEDl7352 Q2W during a 12-week parallel-group treatment period. |
| Cohort 1: Japanese MEDI7352 | EXPERIMENTAL | Randomized Japanese participants will receive single doses of MEDI7352 subcutaneously. |
| Cohort 1: Japanese Placebo | PLACEBO_COMPARATOR | Randomized Japanese participants will receive matching placebo subcutaneously. |
| Cohort 2: Caucasian MEDI7352 | EXPERIMENTAL | Randomized Caucasian participants will receive single doses of MEDI7352 subcutaneously. |
| Cohort 2: Caucasian Placebo | PLACEBO_COMPARATOR | Randomized Caucasian participants will receive matching placebo subcutaneously. |
| Name | Type | Description |
|---|---|---|
| MEDI7352 | DRUG | Participants will receive SC injection of MEDI7352 as stated in arm description. |
| Placebo | OTHER | Participants will receive SC injection of placebo as stated in arm description. |
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...
MEDI7352 is being developed for the treatment of painful osteoarthritis of the knee. It is an investigational therapy that has been studied in clinical trials in adults with this condition, including a Phase 2 efficacy and safety study. It is not approved for any indication.
MEDI7352 is being developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. AstraZeneca sponsored both the Phase 1 and Phase 2 clinical trials of MEDI7352 in painful osteoarthritis of the knee.
MEDI7352 has completed Phase 2 development. Two trials have been conducted: a completed Phase 1 study in healthy volunteers and a completed Phase 2 study in participants with painful osteoarthritis of the knee. MEDI7352 is investigational and has not been approved by the FDA.
MEDI7352 has been evaluated in two completed clinical trials. NCT04770428 was a Phase 1 study of safety, tolerability, pharmacokinetics and immunogenicity in 24 healthy volunteers in the United Kingdom. NCT04675034 was a Phase 2 efficacy and safety study in 345 participants with painful osteoarthritis of the knee across six European countries.
Yes, MEDI7352 for Subcutaneous Injection is another name used for MEDI7352, the AstraZeneca investigational therapy for painful osteoarthritis of the knee. Both names refer to the same drug candidate studied in the Phase 1 and Phase 2 trials.
The Phase 2 trial of MEDI7352, NCT04675034, was a randomized, double-blind, placebo-controlled study that enrolled 345 participants with painful osteoarthritis of the knee. It was conducted in Denmark, Estonia, Germany, Poland, Spain and the United Kingdom, and it has been completed.