A Study of LY3090106 in Participants With Sjögren's Syndrome (SS) (NCT02614716) | Clinical Trial Compass
CompletedPhase 1
A Study of LY3090106 in Participants With Sjögren's Syndrome (SS)
United States, Bulgaria32 participantsStarted 2015-12-10
Plain-language summary
The main purpose of this study is to learn more about the safety and side effects of the study drug known as LY3090106 in participants with Sjögren's Syndrome (SS). The study will also evaluate how much of the study drug gets into the blood stream and how long it takes the body to remove it.
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Have a confirmed diagnosis of SS by the American-European Consensus Group criteria with active disease (at any level), as per judgment of the investigator (participants with another concurrent, stable connective tissue disease may be eligible for inclusion, with written approval from the sponsor).
* Are seropositive for auto-antibodies associated with SS (anti-SSA or anti-SSB) at screening, or documented within 6 months prior to screening.
Exclusion Criteria:
* Are currently enrolled in a clinical trial involving an investigational product or off-label use of a drug, are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study, or have received:
* Any nonbiologic investigational product within 30 days or 5 half-lives (whichever is longer) of study baseline,
* Any biologic investigational product within 3 months or 5 half-lives (whichever is longer) of study baseline, or any leukocyte depleting agent within 12 months of baseline,
* Have synthetic disease-modifying anti-rheumatic drug (DMARD) or immunosuppressive use as follows:
* Any treatment with tofacitinib within 28 days prior to baseline or planned treatment with tofacitinib during the study,
* Unstable prescribed dose of other synthetic DMARDs (eg, hydroxychloroquine, methotrexate, leflunomide, sulfasalazine, or gold salts) within 28 days prior to baseline or if the dose of drug is planned to be increased during …
What they're measuring
1
Number of Participants with One or More Adverse Event(s) Considered by the Investigator to be Related to Study Drug Administration
Timeframe: Baseline through Study Completion (Day 197)