Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04675034 | A Study of the Efficacy and Safety of MEDI7352 in Participants With Painful Osteoarthritis of the Knee | PHASE2 | COMPLETED | 345 | — | — | Dec 2, 2020 | Aug 16, 2023 | Feb 10, 2025 | 41 | Denmark, Estonia +4 |
| NCT04770428 | Evaluate Safety, Tolerability, Pharmacokinetics and Immunogenicity of MEDI7352 in Healthy Volunteers | PHASE1 | COMPLETED | 24 | — | — | Apr 20, 2021 | Dec 2, 2021 | Dec 15, 2021 | 1 | United Kingdom |
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...