a phase 2a, randomized, placebo controlled, study to evaluate the safety and efficacy of amg 557/medi5872 in primary sjögren's syndrome

Conditions: Primary Sjögren's Syndrome

Summary: a phase 2a study to evaluate the efficacy and safety of amg 557/medi5872 in primary sjögren's syndrome

this is a phase 2a, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the clinical and biologic efficacy, as well as the safety of sc doses of amg 557/medi5872 in adult subjects with primary sjögren's syndrome.

Eligibility criteria:
inclusion criteria: * age 18 through 75 years at the time of signing the icf. * fulfill american-european consensus group (aecg) criteria for pss * essdai score ≥ 6. * positive anti-ss-a and/or anti-ss-b autoantibodies and at least igg \> 13 g/l or rf level \> upper limit of normal (uln) or positive test for cryoglobulins * willingness to undergo protocol-required minor salivary gland biopsies. * negative tb test during screening * immunization up to date as determined by local standard of care. exclusion criteria: * previous treatment with amg 557/medi5872. * evidence of signs or symptoms of a viral, bacterial, or fungal infection within 2 weeks (14 days) prior to randomization (day 1) according to the assessment of the investigator; any infection requiring iv antibiotic or antiviral treatment within 8 weeks of randomization (day 1); history of herpes zoster within 3 months prior to randomization (day 1). * evidence of significant renal insufficiency * positive test at screening for hepatitis b, hepatitis c, or human immunodeficiency virus (hiv) antibody. * prior administration of any of the following: 1. belimumab in the past 6 months prior to randomization (day 1); 2. rituximab in the past 12 months or cd19+ b cells \< 5/µl if rituximab treatment was more than 12 months prior to randomization (day 1); 3. abatacept in the past 6 months prior to randomization (day 1); 4. tumor necrosis factor inhibitors (adalimumab, certolizumab, etanercept, golimumab, infliximab) in the past 3 months prior to randomization (day 1); 5. tocilizumab in the past 3 months prior to randomization (day 1); 6. cyclophosphamide (or any other alkylating agent) in the past 6 months prior to randomization (day 1); cyclosporine (except for eye drops), tacrolimus, sirolimus, mycophenolate mofetil, azathioprine, or leflunomide in the past 3 months prior to randomization (day 1). * receiving any of the following: 1. corticosteroids: \> 10 mg/day oral prednisone (or equivalent); any change or initiation of new dose within 4 weeks prior to signing the icf through randomization (day 1); intramuscular, iv, or intra-articular corticosteroids within 4 weeks prior to signing the icf through randomization (day 1); any change or initiation of new dose of topical corticosteroids within 2 weeks prior to signing the icf through randomization (day 1); 2. antimalarials: any increase or initiation of new dose of antimalarials (eg, chloroquine, hydroxychloroquine, quinacrine) within 12 weeks prior to signing the icf through randomization (day 1). 3. methotrexate: \> 20 mg/week methotrexate; any change or initiation of new dose of methotrexate within 4 weeks prior to signing the icf through randomization (day 1); any change in route of administration. 4. any increase or initiation of new dose of regularly scheduled nonsteroidal anti inflammatory drugs (nsaids) within 2 weeks prior to signing the icf through randomization (day 1). 5. cevimeline or pilocarpine and cyclosporine eye drops (restasis): any increase or initiation of new doses within 2 weeks prior to signing the icf through randomization (day 1).