EUCTR2014-003896-41-GB进行中（未招募）1 期
A Phase 2a, Randomized, Placebo-controlled, Proof of Mechanism Study to Evaluate the Safety and Efficacy of AMG 557/MEDI5872 in Subjects with Primary Sjogren’s Syndrome
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Age 18 through 75 years at the time of signing the informed consent form (ICF).
- •6. Fulfill American-European Consensus Group (AECG) criteria for pSS.
- •7. European League Against Rheumatism Sjogren’s Syndrome Disease Activity Index (ESSDAI) score = 6.
- •8. Positive anti-SS-A and/or anti-SS-B autoantibodies AND at least one of the following laboratory abnormalities:
- •a. Immunoglobulin G (IgG) > 13 g/L
- •b. Rheumatoid factor (RF) level > upper limit of normal (ULN)
- •c. Positive test for cryoglobulins
- •9. Willingness to undergo protocol-required minor salivary gland biopsies.
- •10. Meet all of the following tuberculosis (TB) criteria (see protocol)
- •11. Immunization up to date as determined by local standard of care.
- •For a detailed list of inclusion criteria, please refer to the protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 38
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •3. Previous treatment with AMG 557/MEDI5872.
- •4. Evidence of signs or symptoms of a viral, bacterial, or systemic fungal infection within 2 weeks (14 days) prior to randomization (Day 1) according to the assessment of the investigator; any infection requiring intravenous (IV) antibiotic or antiviral treatment within 8 weeks of randomization (Day 1); history of herpes zoster within 3 months prior to randomization (Day 1).
- •6. Evidence of significant renal insufficiency, defined by estimated glomerular filtration rate (eGFR) < 30 mL/minute/1.73m2.
- •7. Positive test at screening for either hepatitis B surface antigen, hepatitis B core antibody, hepatitis C antibody, or human immunodeficiency virus (HIV) antibody.
- •16. Prior administration of any of the following:
- •a. Belimumab in the past 6 months prior to randomization (Day 1);
- •b. 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);
- •c. Abatacept in the past 6 months prior to randomization (Day 1);
- •d. Tumor necrosis factor inhibitors (adalimumab, certolizumab, etanercept, golimumab, infliximab) in the past 3 months prior to randomization (Day 1);
- •e. Tocilizumab in the past 3 months prior to randomization (Day 1);
- •f. 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).
- •20. Receiving any of the following:
- •a. Corticosteroids:
- •i. > 10 mg/day oral prednisone (or equivalent);
- •ii. Any change or initiation of new dose of oral corticosteroids within 4 weeks prior to signing the ICF through randomization (Day 1);
- •iii. Intramuscular, IV, or intra-articular corticosteroids within 4 weeks prior to signing the ICF through randomization (Day 1);
- •iv. Any change or initiation of new dose of topical corticosteroids within 2 weeks prior to signing the ICF through randomization (Day 1);
- •b. 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).
- •c. Methotrexate:
- •i. > 20 mg/week methotrexate;
- •ii. Any change or initiation of new dose of methotrexate within 4 weeks prior to signing the ICF through randomization (Day 1);
- •iii. Any change in route of administration.
- •d. 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).
- •e. Any increase or initiation of new doses of cevimeline or pilocarpine and cyclosporine eye drops (Restasis) within 2 weeks prior to signing the ICF through randomization (Day 1).
- •For a detailed list of exclusion criteria, please refer to the protocol.
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