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Completed

NCT Number: NCT02144272

Safety Study to Evaluate LY3114062 in Participants With Inflammatory Arthritis

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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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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, Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LY3114062 SC

Drug

LY3114062 administered SC.

Placebo

Drug

Placebo administered SC.

LY3114062 IV

Drug

LY3114062 administered IV.

Primary outcomes

  1. The Number of Participants with One or More Drug-Related Adverse Events

    Time frame: Baseline to study completion (3 months)

Secondary outcomes

  1. Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY3114062

    Time frame: Predose through Day 85, at specified timepoints

  2. Pharmacokinetics: Area Under the Concentration-time curve (AUC) of LY3114062

    Time frame: Predose through Day 85, at specified timepoints

  3. Antibody Production Against LY3114062

    Time frame: Day 1, 8, 15, 29, 85 and early discontinuation

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 21, 2014
Registry last updated
Jul 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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