A Phase 2a, Randomized, Placebo Controlled, Study to Evaluate the Safety and Efficacy of AMG 557/MEDI5872 in Primary Sjögren's Syndrome

Completed · Phase 2 · Has a placebo group

Conditions studied: Primary Sjögren's Syndrome

In brief

A Phase 2a study to evaluate the efficacy and safety of AMG 557/MEDI5872 in Primary Sjögren's Syndrome

Key facts

Study ID

NCT02334306

Run by

MedImmune LLC

People needed

32

Starts

2015-06-08

Expected to finish

2018-08-13

Last updated by the study team

2019-03-19

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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:
• Belimumab in the past 6 months prior to randomization (Day 1);
• 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);
• Abatacept in the past 6 months prior to randomization (Day 1);
• Tumor necrosis factor inhibitors (adalimumab, certolizumab, etanercept, golimumab, infliximab) in the past 3 months prior to randomization (Day 1);
• Tocilizumab in the past 3 months prior to randomization (Day 1);
• 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:
• 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);
• 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).
• 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.
• 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).
• 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).

Where it is running

• Research Site — San Francisco, California, United States
• Research Site — Bethesda, Maryland, United States
• Research Site — Pittsburgh, Pennsylvania, United States
• Research Site — Brest, France
• Research Site — Le Kremlin-Bicêtre, France
• Research Site — Lille, France
• Research Site — Paris, France
• Research Site — Paris, France
• Research Site — Strasbourg, France
• Research Site — Stockholm, Sweden
• Research Site — London, United Kingdom
• Research Site — Newcastle upon Tyne, United Kingdom
• Research Site — Swindon, United Kingdom

Full record on ClinicalTrials.gov

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