Clinical trial NCT02144272: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Inflammatory Arthritis
Keywords: Antibody
Tumor Necrosis Factor alpha
Interleukin-17
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2014-05-21
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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.

Primary outcomes:
measure: The Number of Participants with One or More Drug-Related Adverse Events
timeFrame: Baseline to study completion (3 months)
Secondary outcomes:
measure: Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY3114062
timeFrame: Predose through Day 85, at specified timepoints
measure: Pharmacokinetics: Area Under the Concentration-time curve (AUC) of LY3114062
timeFrame: Predose through Day 85, at specified timepoints
measure: Antibody Production Against LY3114062
timeFrame: Day 1, 8, 15, 29, 85 and early discontinuation
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: 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
country: Georgia
facility: 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
country: Moldova, Republic of
facility: 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
country: Romania
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: