Safety Study to Evaluate LY3114062 in Participants With Inflammatory Arthritis

Inflammatory Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02144272
• Other study ID #: 15098
• Secondary ID: I6W-MC-TNAA
• Status: Completed
• Phase: Phase 1
• First received: May 19, 2014
• Last updated: July 15, 2015
• Start date: June 2014
• Est. completion date: June 2015

Study information

• Verified date: July 2015
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBulgaria: Bulgarian Drug AgencyBulgaria: Ethics committeeMoldova: Medicines AgencyMoldova: Ministry of HealthMoldova: National Ethics CommitteeRomania: National Bioethics Committee of Medicines and Medical DevicesRomania: National Agency for Medicines and Medical DevicesGeorgia: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: June 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Arthritis
• Inflammatory Arthritis

Intervention

Drug:
• LY3114062 SC
LY3114062 administered SC.
• Placebo
Placebo administered SC.
• LY3114062 IV
LY3114062 administered IV.

Locations

Country	Name	City	State
Bulgaria	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
Georgia	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.	Tbilisi
Moldova, Republic of	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.	Chisinau
Romania	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

Bulgaria,  Georgia,  Moldova, Republic of,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Number of Participants with One or More Drug-Related Adverse Events		Baseline to study completion (3 months)	Yes
Secondary	Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY3114062		Predose through Day 85, at specified timepoints	No
Secondary	Pharmacokinetics: Area Under the Concentration-time curve (AUC) of LY3114062		Predose through Day 85, at specified timepoints	No
Secondary	Antibody Production Against LY3114062		Day 1, 8, 15, 29, 85 and early discontinuation	No