Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| I6W-MC-TNAA | Other Identifier | Eli Lilly and Company |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The main purpose of this study is to learn more about the safety of LY3114062 and to find out how well it is tolerated in participants with an inflammatory arthritis. The study will also investigate how the body processes the drug and how the drug affects inflammatory arthritis. The study is expected to last about 3 months.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3114062 (SC) | Experimental | LY3114062 given as a single subcutaneous (SC) dose, in escalating dose cohorts starting at 2 mg. |
|
| LY3114062 (IV) | Experimental | LY3114062 given once intravenous (IV). |
|
| Placebo | Placebo Comparator | Placebo (sodium chloride injection) given as a single SC dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3114062 SC | Drug | LY3114062 administered SC. |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Participants with One or More Drug-Related Adverse Events | Baseline to study completion (3 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY3114062 | Predose through Day 85, at specified timepoints | |
| Pharmacokinetics: Area Under the Concentration-time curve (AUC) of LY3114062 | Predose through Day 85, at specified timepoints |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Synthetic disease-modifying antirheumatic drugs DMARD use as follows:
Previous treatment with marketed biologic DMARDs as follows:
Note: Other biologic agents for indications other than an inflammatory arthritis may be allowed after discussion with the sponsor
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM-5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Sofia | 1612 |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Placebo administered SC. |
|
| LY3114062 IV | Drug | LY3114062 administered IV. |
|
| Antibody Production Against LY3114062 | Day 1, 8, 15, 29, 85 and early discontinuation |
| Bulgaria |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Tbilisi | 0112 | Georgia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Chisinau | MD2025 | Moldova |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bucharest | 50159 | Romania |