Safety Study to Evaluate LY3114062 in Participants With Inflammatory Arthritis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-06-30

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.

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Detailed Description

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Conditions

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Inflammatory Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LY3114062 (SC)

LY3114062 given as a single subcutaneous (SC) dose, in escalating dose cohorts starting at 2 mg.

Group Type EXPERIMENTAL

LY3114062 SC

Intervention Type DRUG

LY3114062 administered SC.

LY3114062 (IV)

LY3114062 given once intravenous (IV).

Group Type EXPERIMENTAL

LY3114062 IV

Intervention Type DRUG

LY3114062 administered IV.

Placebo

Placebo (sodium chloride injection) given as a single SC dose.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo administered SC.

Interventions

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LY3114062 SC

LY3114062 administered SC.

Intervention Type DRUG

Placebo

Placebo administered SC.

Intervention Type DRUG

LY3114062 IV

LY3114062 administered IV.

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No