Safety Study to Evaluate LY3114062 in Participants With Inflammatory Arthritis

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1 Single-Dose, Dose Escalation Study to Evaluate the Safety and Tolerability of LY3114062 in Subjects With Inflammatory Arthritis

Conditions
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Inflammatory Arthritis

Intervention / Treatment
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* Drug: LY3114062 SC
* Drug: Placebo
* Drug: LY3114062 IV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signs or symptoms of an inflammatory arthritis for a duration of at least 8 weeks at screening. Presence of at least 3 out of 66 swollen joints at screening and baseline, as determined by the swollen joint count assessment forms. Exclusion Criteria: Synthetic disease-modifying antirheumatic drugs DMARD use as follows: ANY treatment with tofacitinib within 28 days prior to baseline or planned treatment with tofacitinib during the study; Treatment with other synthetic DMARDs (eg, hydroxychloroquine, methothrexate, leflunomide, sulfasalazine, and gold salts) at an unstable dose within 28 days prior to baseline or if the dose of drug is planned to be changed during the study. Previous treatment with marketed biologic DMARDs as follows: Etanercept, adalimumab, or anakinra <4 weeks prior to baseline; Infliximab, certolizumab pegol, golimumab, abatacept, or tocilizumab <8 weeks prior to baseline; Rituximab <12 months prior to baseline Note: Other biologic agents for indications other than an inflammatory arthritis may be allowed after discussion with the sponsor Treatment with >10 mg/day, or unstable dose, of oral prednisone or equivalent within 28 days prior to baseline. Confirmed or suspected septic arthritis, crystal arthropathy, systemic lupus erythematosus, reactive arthritis, or certain other rheumatic conditions.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3114062 (SC)<br>LY3114062 given as a single subcutaneous (SC) dose, in escalating dose cohorts starting at 2 mg. | Drug: LY3114062 SC<br>* LY3114062 administered SC.<br>|
| Experimental: LY3114062 (IV)<br>LY3114062 given once intravenous (IV). | Drug: LY3114062 IV<br>* LY3114062 administered IV.<br>|
| Placebo Comparator: Placebo<br>Placebo (sodium chloride injection) given as a single SC dose. | Drug: Placebo<br>* Placebo administered SC.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Participants with One or More Drug-Related Adverse Events |  | Baseline to study completion (3 months) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Antibody Production Against LY3114062 |  | Day 1, 8, 15, 29, 85 and early discontinuation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antibody, Tumor Necrosis Factor alpha, Interleukin-17