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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04456686 | Chronic Pain Master Protocol (CPMP): A Study of LY3016859 in Participants With Osteoarthritis | PHASE2 | COMPLETED | 117 | — | — | Jul 1, 2020 | Aug 26, 2021 | Nov 14, 2023 | 33 | United States, Puerto Rico |
The NRS was used during the preliminary data entry period and daily throughout the study to describe pain severity. Participants were asked to describe their average pain over the past 24 hours, on a scale of 0 to 10: 0 = no pain, and 10 = pain as bad as you can imagine. Posterior mean change from baseline, 95% credible interval (CrI) was derived using Bayesian mixed model repeated measures. The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals.
| Arm | Type | Description |
|---|---|---|
| 750 Mg-500 mg LY3016859 | EXPERIMENTAL | Participants received LY3016859 every 2 weeks with 750 milligram (mg) as starting dose followed by 500 mg intravenous (IV) infusion for a total of 4 doses. |
| Placebo | PLACEBO_COMPARATOR | Participants received placebo every 2 weeks by IV infusion for a total of 4 doses. |
| Name | Type | Description |
|---|---|---|
| LY3016859 | DRUG | LY3016859 given IV. |
| Placebo | DRUG | Placebo given IV. |
Inclusion Criteria: * Have a visual analog scale (VAS) pain value ≥40 and \<95 during screening. * Have a history of daily pain for at least 12 weeks based on participant report or medical history. * Have a value of ≤30 on the pain catastrophizing scale. * Have a body mass index \<40 kilograms per ...