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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_1

Timeline

Completed

Started Jun 2014

Geographic Reach

4 countries

4 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1 year study duration

First Submitted

Initial submission to the registry

May 19, 2014

Completed

2 days until next milestone

First Posted

Study publicly available on registry

May 21, 2014

Completed

11 days until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed

11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed

Last Updated

July 17, 2015

Status Verified

July 1, 2015

Enrollment Period

11 months

First QC Date

May 19, 2014

Last Update Submit

July 15, 2015

Conditions

Inflammatory Arthritis

Keywords

AntibodyTumor Necrosis Factor alphaInterleukin-17

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

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

Study Arms (3)

LY3114062 (SC)

EXPERIMENTAL

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

Drug: LY3114062 SC

LY3114062 (IV)

EXPERIMENTAL

LY3114062 given once intravenous (IV).

Drug: LY3114062 IV

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

LY3114062 SCDRUG

LY3114062 administered SC.

LY3114062 (SC)

PlaceboDRUG

Placebo administered SC.

Placebo

LY3114062 IVDRUG

LY3114062 administered IV.

LY3114062 (IV)

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (4)

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, Bulgaria

Location

Tbilisi, 0112, Georgia

Location

Chisinau, MD2025, Moldova

Location

Bucharest, 50159, Romania

Location

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

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

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: BASIC SCIENCE
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 19, 2014

First Posted

May 21, 2014

Study Start

June 1, 2014

Primary Completion

May 1, 2015

Study Completion

June 1, 2015

Last Updated

July 17, 2015

Record last verified: 2015-07

Locations

GE(1)MO(1)RO(1)BU(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (3)

LY3114062 (SC)

LY3114062 (IV)

Placebo

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (4)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations