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Safety Study to Evaluate LY3114062 in Participants With Inflammatory Arthritis

Primary Purpose

Inflammatory Arthritis

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
LY3114062 SC
Placebo
LY3114062 IV
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Inflammatory Arthritis focused on measuring Antibody, Tumor Necrosis Factor alpha, Interleukin-17

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • 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.
  • 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.
  • 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.
  • 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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

LY3114062 (SC)

LY3114062 (IV)

Placebo

Arm Description

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

LY3114062 given once intravenous (IV).

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY3114062
Pharmacokinetics: Area Under the Concentration-time curve (AUC) of LY3114062
Antibody Production Against LY3114062

Full Information

First Posted
May 19, 2014
Last Updated
July 15, 2015
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT02144272
Brief Title
Safety Study to Evaluate LY3114062 in Participants With Inflammatory Arthritis
Official Title
A Phase 1 Single-Dose, Dose Escalation Study to Evaluate the Safety and Tolerability of LY3114062 in Subjects With Inflammatory Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Arthritis
Keywords
Antibody, Tumor Necrosis Factor alpha, Interleukin-17

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LY3114062 (SC)
Arm Type
Experimental
Arm Description
LY3114062 given as a single subcutaneous (SC) dose, in escalating dose cohorts starting at 2 mg.
Arm Title
LY3114062 (IV)
Arm Type
Experimental
Arm Description
LY3114062 given once intravenous (IV).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (sodium chloride injection) given as a single SC dose.
Intervention Type
Drug
Intervention Name(s)
LY3114062 SC
Intervention Description
LY3114062 administered SC.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo administered SC.
Intervention Type
Drug
Intervention Name(s)
LY3114062 IV
Intervention Description
LY3114062 administered IV.
Primary Outcome Measure Information:
Title
The Number of Participants with One or More Drug-Related Adverse Events
Time Frame
Baseline to study completion (3 months)
Secondary Outcome Measure Information:
Title
Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY3114062
Time Frame
Predose through Day 85, at specified timepoints
Title
Pharmacokinetics: Area Under the Concentration-time curve (AUC) of LY3114062
Time Frame
Predose through Day 85, at specified timepoints
Title
Antibody Production Against LY3114062
Time Frame
Day 1, 8, 15, 29, 85 and early discontinuation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Sofia
ZIP/Postal Code
1612
Country
Bulgaria
Facility Name
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.
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Facility Name
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.
City
Chisinau
ZIP/Postal Code
MD2025
Country
Moldova, Republic of
Facility Name
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.
City
Bucharest
ZIP/Postal Code
50159
Country
Romania

12. IPD Sharing Statement

Learn more about this trial

Safety Study to Evaluate LY3114062 in Participants With Inflammatory Arthritis

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