Clinical trial · Interventional
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
NCT02144272CI-TRIAL-00018576completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Inflammatory Arthritis | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LY3114062 IV | Drug | — | UNRESOLVED |
| LY3114062 SC | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- LY3114062 (SC)
- description
- LY3114062 given as a single subcutaneous (SC) dose, in escalating dose cohorts starting at 2 mg.
- interventionNames
- Drug: LY3114062 SC
- type
- EXPERIMENTAL
- label
- LY3114062 (IV)
- description
- LY3114062 given once intravenous (IV).
- interventionNames
- Drug: LY3114062 IV
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo (sodium chloride injection) given as a single SC dose.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.