Safety Study to Evaluate LY3114062 in Participants With Inflammatory Arthritis

Phase 1

Completed

• Conditions: Inflammatory Arthritis
• Interventions: Drug: Placebo; Drug: LY3114062 SC; Drug: LY3114062 IV

• Registration Number: NCT02144272
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-19
• Study First Submitted QC: 2014-05-19
• Study First Posted: 2014-05-21
• Study Start: 2014-06
• Primary Completion: 2015-05
• Study Completion: 2015-06
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-15
• Last Update Posted: 2015-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo (sodium chloride injection) given as a single SC dose.
LY3114062 (SC)	LY3114062 SC	LY3114062 given as a single subcutaneous (SC) dose, in escalating dose cohorts starting at 2 mg.
LY3114062 (IV)	LY3114062 IV	LY3114062 given once intravenous (IV).

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Antibody Production Against LY3114062	Day 1, 8, 15, 29, 85 and early discontinuation
Pharmacokinetics: Area Under the Concentration-time curve (AUC) of LY3114062	Predose through Day 85, at specified timepoints
Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY3114062	Predose through Day 85, at specified timepoints

Trial Locations

Locations (1)

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.; 🇷🇴 Bucharest, Romania