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A Study of LY3090106 in Participants With Sjögren's Syndrome (SS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02614716
Recruitment Status : Completed
First Posted : November 25, 2015
Last Update Posted : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE November 24, 2015
First Posted Date  ICMJE November 25, 2015
Last Update Posted Date December 11, 2018
Actual Study Start Date  ICMJE December 10, 2015
Actual Primary Completion Date September 5, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 24, 2015)
Number of Participants with One or More Adverse Event(s) Considered by the Investigator to be Related to Study Drug Administration [ Time Frame: Baseline through Study Completion (Day 197) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 24, 2015)
  • Pharmacokinetics: Maximum Concentration (Cmax) of LY3090106 [ Time Frame: Baseline through Day 197 ]
  • Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3090106 [ Time Frame: Baseline through Day 197 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of LY3090106 in Participants With Sjögren's Syndrome (SS)
Official Title  ICMJE A Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3090106 in Subjects With Sjögren's Syndrome
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Sjögren's Syndrome
Intervention  ICMJE
  • Drug: LY3090106
    Administered SC
  • Drug: Placebo
    Administered SC
Study Arms  ICMJE
  • Experimental: LY3090106
    LY3090106 given subcutaneously (SC) in escalating dose cohorts once every 2 or 4 weeks for 16 weeks.
    Intervention: Drug: LY3090106
  • Placebo Comparator: Placebo
    Placebo given subcutaneously (SC) once every 2 or 4 weeks for 16 weeks.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 24, 2015)
32
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 5, 2018
Actual Primary Completion Date September 5, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 the study. (Stable prescriptions are allowed.)
    • Cytotoxic or immunosuppressive drugs including but not limited to cyclophosphamide, mycophenolic acid, azathioprine, cyclosporine, sirolimus, or tacrolimus within 28 days prior to screening or planned treatment during the study.
  • Have had treatment with biologic DMARDs as follows:

    • Etanercept, adalimumab, or anakinra <4 weeks before baseline or planned treatment during the study.
    • Infliximab, certolizumab pegol, golimumab, abatacept, or tocilizumab <8 weeks before baseline or planned treatment during the study.
    • Rituximab, belimumab or other leukocyte depleting agent <12 months before baseline or planned treatment during the study. Note: other biologic agents may be allowed after written approval from the sponsor.
  • Have a prescribed dose >10 milligrams (mg)/day of oral prednisone (or equivalent) within 28 days before baseline, or plan to increase >10 mg/day during the study. (Stable prescriptions ≤10 mg/day are allowed.) Treatment with inhaled or parenteral corticosteroids within 28 days prior to baseline is prohibited. A single intra-articular corticosteroid injection is permitted within 28 days prior to baseline if no more than 40 mg triamcinolone (or equivalent) is administered. The treated joint should be excluded from any joint-specific evaluations during the study.
  • Have an unstable prescribed dose of a cholinergic stimulant (eg, pilocarpine, cevimeline) within 28 days prior to baseline. (Stable prescriptions are allowed.)
  • Have an unstable prescribed dose of cyclosporine eye drops within 28 days prior to baseline. (Stable prescriptions are allowed.)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   Georgia,   Romania,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02614716
Other Study ID Numbers  ICMJE 16149
I6M-MC-SSAD ( Other Identifier: Eli Lilly and Company )
2015-003523-62 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: 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) Eli Lilly and Company
PRS Account Eli Lilly and Company
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP