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

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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

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.

Condition or disease Intervention/treatment Phase
Sjögren's Syndrome Drug: LY3090106 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3090106 in Subjects With Sjögren's Syndrome
Actual Study Start Date : December 10, 2015
Actual Primary Completion Date : September 5, 2018
Actual Study Completion Date : September 5, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LY3090106
LY3090106 given subcutaneously (SC) in escalating dose cohorts once every 2 or 4 weeks for 16 weeks.
Drug: LY3090106
Administered SC

Placebo Comparator: Placebo
Placebo given subcutaneously (SC) once every 2 or 4 weeks for 16 weeks.
Drug: Placebo
Administered SC




Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. Pharmacokinetics: Maximum Concentration (Cmax) of LY3090106 [ Time Frame: Baseline through Day 197 ]
  2. Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3090106 [ Time Frame: Baseline through Day 197 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02614716


Locations
United States, Maryland
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
United States, New Mexico
New Mexico Clinical Research & Osteoporosis Center
Albuquerque, New Mexico, United States, 87106
United States, North Carolina
NorthEast Rheumatology
Concord, North Carolina, United States, 28025
United States, Pennsylvania
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
Bulgaria
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician
Sofia, Bulgaria, 1612
Georgia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician
Tbilisi, Georgia, 0112
Romania
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician
Bucharest, Romania, 050159
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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

Additional Information:
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02614716     History of Changes
Other Study ID Numbers: 16149
I6M-MC-SSAD ( Other Identifier: Eli Lilly and Company )
2015-003523-62 ( EudraCT Number )
First Posted: November 25, 2015    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018

Additional relevant MeSH terms:
Syndrome
Sjogren's Syndrome
Disease
Pathologic Processes
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases