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Summary

for people ages 18–75 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

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

Official Title

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

Details

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.

Keywords

Primary Sjögren's Syndrome Syndrome Sjogren's Syndrome

Eligibility

You can join if…

Open to people ages 18–75

  • 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 CAN'T join 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).

Locations

  • Research Site accepting new patients
    San Francisco, California, 94143, United States
  • Research Site accepting new patients
    Pittsburgh, Pennsylvania, 15213, United States
  • Research Site completed
    Bethesda, Maryland, 20892-1190, United States
  • Research Site accepting new patients
    London, EC1M 6BQ, United Kingdom
  • Research Site accepting new patients
    Newcastle-upon-Tyne, NE2 4HH, United Kingdom
  • Research Site accepting new patients
    Swindon, SN3 6BB, United Kingdom
  • Research Site withdrawn
    Malmö, 21428, Sweden
  • Research Site accepting new patients
    Stockholm, Sweden
  • Research Site accepting new patients
    Brest Cedex, 29609, France
  • Research Site accepting new patients
    Le Kremlin-bicêtre, 94275, France
  • Research Site accepting new patients
    Lille Cedex, 59037, France
  • Research Site accepting new patients
    Paris Cedex 13, 75651, France
  • Research Site accepting new patients
    Paris, 75014, France
  • Research Site accepting new patients
    Strasbourg, 67098, France

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
MedImmune LLC
ID
NCT02334306
Phase
Phase 2
Lead Scientist
Maria Dall'Era
Study Type
Interventional
Last Updated
September 14, 2017
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