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

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.

Study Overview

• Status: Completed
• Conditions: Inflammatory Arthritis
• Intervention / Treatment: Drug: LY3114062 SC; Drug: LY3114062 IV; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 1

Contacts and Locations

Study Locations

• Bulgaria
  • Sofia, Bulgaria, 1612
    • 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.
• Georgia
  • Tbilisi, Georgia, 0112
    • 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.
• Moldova, Republic of
  • Chisinau, Moldova, Republic of, MD2025
    • 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.
• Romania
  • Bucharest, Romania, 50159
    • 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.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: LY3114062 (SC); LY3114062 given as a single subcutaneous (SC) dose, in escalating dose cohorts starting at 2 mg.	Drug: LY3114062 SC; LY3114062 administered SC.
EXPERIMENTAL: LY3114062 (IV); LY3114062 given once intravenous (IV).	Drug: LY3114062 IV; LY3114062 administered IV.
PLACEBO_COMPARATOR: Placebo; Placebo (sodium chloride injection) given as a single SC dose.	Drug: Placebo; Placebo administered SC.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (ACTUAL): May 1, 2015
• Study Completion (ACTUAL): June 1, 2015

Study Registration Dates

• First Submitted: May 19, 2014
• First Submitted That Met QC Criteria: May 19, 2014
• First Posted (ESTIMATE): May 21, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): July 17, 2015
• Last Update Submitted That Met QC Criteria: July 15, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Antibody; Interleukin-17; Tumor Necrosis Factor alpha
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis
• Other Study ID Numbers: 15098; I6W-MC-TNAA (OTHER: Eli Lilly and Company)