EUCTR2021-000962-14-DE进行中（未招募）1 期
A Monocenter, Open Label Study to Evaluate the Safety and Efficacy of Daratumumab in Combination with Standard Background Therapy in Participants with Moderate to Severe Systemic Lupus Erythematosus - DARALUP
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 10
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
- 性别
- All
入选标准
- •1. diagnosis of SLE according to the 2019 EULAR/ACR Systemic Lupus Erythematosus classification criteria.
- •2. age between 18 and 60 years, inclusive, at consent.
- •3. have a body mass index (BMI) between 18 and 32 kg/m² (BMI = weight/height2), inclusive, and a body weight of no less than 35 kg.
- •4. demonstrate moderate to severe disease based on SLEDAI-2K score = 6 observed at screening
- •5. SLEDAI-2K = 4 for clinical features (i.e. SLEDAI excluding laboratory results) at screening
- •6. have a positive anti-double stranded desoxyribonucleic acid (anti-dsDNA) test, as measured by enzyme-linked immunosorbent assay (ELISA) test.
- •7. Failure or lack of tolerability of at least 2 previous state-of-the-art immunosuppressive drugs/immunomodulatory drugs including antimalarials (does not account for glucocorticoids).
- •8. if using oral corticosteroids, must be receiving this medication for at least 4 weeks and on a stable dose equivalent to an average dose of <20 mg of prednisone daily for at least 4 weeks prior to the first dose of study agent.
- •9. if using immunosuppressive drugs within the past 6 months, must not have exceeded the following dose levels: methotrexate 25 mg/week, azathioprine 2mg/kg/day, mycophenolate mofetil (MMF) 3g/day, or mycophenolic acid (MPA) 1440mg/day.
- •10. if using immunosuppressive drugs, must be using not more than 1 immunosuppressive drug (does not account for antimalarials and glucocorticoids) and not have used any additional immunosuppressive drug within the past 3 months prior to the first dose of study agent.
- •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 10
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- has any unstable or progressive manifestation of SLE (lupus cerebritis, optic neuritis, transverse myelitis, psychosis, uncontrolled seizures, systemic vasculitis, end-stage renal disease, rapidly progressive Class III or IV glomerulonephritis, isolated Class V lupus nephritis [i.e. without coexistent Class I, II, III, or IV nephritis], Class VI lupus nephritis, pulmonary hemorrhage, myocarditis) that is likely to warrant escalation in therapy beyond permitted background medications. Subjects requiring renal hemodialysis or peritoneal dialysis are also excluded.
- •- has or has had a history of any clinically significant medical illness, or medical disorders the investigator considers significant should exclude the participant, including (but not limited to), hematological disease, immune deficiency states, respiratory disease, cardiovascular disease (including poor peripheral venous access), hepatic or gastrointestinal (GI) disease, neurological or psychiatric disease, ophthalmological disorders, neoplastic disease, renal or urinary tract diseases, or dermatological disease.
- •- has or has had a serious infection (e.g. sepsis, pneumonia, or pyelonephritis), or been hospitalized or received IV antibiotics for a serious infection during the 3 months prior to consent.
- •- had major surgery, (e.g. requiring general anesthesia) within 3 months before screening.
- •- has or has had an acute illness, including a common cold, within 2 weeks prior to first study treatment or has had a major illness or hospitalization within 3 months prior to consent.
- •- has other inflammatory diseases that might confound the evaluations of efficacy, including but not limited to rheumatoid arthritis (RA), psoriatic arthritis.
- •- has received, is known to have received, or is suspected to have an intolerance or hypersensitivity (including delayed-type hypersensitivity) to any monoclonal antibodies or antibody fragments, is known to have allergies or clinically significant reactions to human proteins, monoclonal antibodies, or antibody fragments, or to any components of the formulation used in this study, including daratumumab.
- •- has received any live virus or bacterial vaccinations within 12 weeks prior to first study treatment or is expected to receive any live virus or bacterial vaccinations during the study or up to 20 weeks after last study treatment.
- •- has received B cell depleting therapy within 12 months prior to first administration of the study agent (e.g. rituximab, ocrelizumab or obinutuzumab),
- •- has received a therapy that inhibits B-cell activating factor (BAFF) (i.e. belimumab) within 3 months prior to first administration of the study agent.
- •- has received prior experimental immunosuppressive biologic therapy for lupus (other than that described as allowed), less than 5 half-lives or 6 months, whichever is longer prior to first administration of the study agent.
- •- has used oral or IV cyclophosphamide within 2 months prior to first administration of the study agent.
- •- has ever been exposed to daratumumab or any anti-CD38 antibodies (e.g. TAK-079, MOR202, isatuximab).
- •- has a history of, or ongoing, chronic or recurrent infection/diagnosed latent infection, including but not limited to, chronic renal infection, chronic chest infection (e.g. bronchiectasis), sinusitis, recurrent urinary tract infection (e.g. recurrent pyelonephritis), an open, draining, or infected skin wound, or an ulcer.
- •- has or has had a serious infection (e.g. sepsis, pn
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