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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02614716
• Date of registration: 24/11/2015
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company
• Public title: A Study of LY3090106 in Participants With Sjögren's Syndrome (SS)
• Scientific title: A Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3090106 in Subjects With Sjögren's Syndrome
• Date of first enrolment: December 10, 2015
• Target sample size: 32
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02614716
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: Double (Participant, Investigator).
• Phase: Phase 1

Countries of recruitment

Bulgaria, Georgia, Romania, United States

Contacts

• 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)
• Affiliation: Eli Lilly and Company

Key inclusion & exclusion 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.)



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Sjögren's Syndrome

Intervention(s)

Drug: LY3090106

Drug: Placebo

Primary Outcome(s)

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(s)

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]

Secondary ID(s)

16149

I6M-MC-SSAD

2015-003523-62

Source(s) of Monetary Support

Please refer to primary and secondary sponsors