Safety Study to Evaluate LY3114062 in Participants With Inflammatory Arthritis

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02144272

Enrollment

Registered

2014-05-21

Start date

2014-06-30

Completion date

2015-06-30

Last updated

2015-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Arthritis

Keywords

Antibody, Tumor Necrosis Factor alpha, Interleukin-17

Brief summary

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.

Interventions

DRUGLY3114062 SC

LY3114062 administered SC.

DRUGPlacebo

Placebo administered SC.

DRUGLY3114062 IV

LY3114062 administered IV.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	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

Countries

Bulgaria, Georgia, Moldova, Romania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026