EUCTR2019-000720-17-IT进行中（未招募）1 期
Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double-blind, Placebo-controlled Study with a Long-term Open-label Extension -
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 105
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
- •Inclusion Criteria - Double blind period
- •1. Male or female =18 years of age.
- •2. Diagnosed with active primary or secondary wAIHA, defined as having all of the following:
- •a.Hemoglobin concentration <9 g/dL or <10 g/dL if symptomatic or on corticosteroids/immunosuppressants AND
- •b.Signs of hemolysis, defined as: lactate dehydrogenase (LDH) levels above the upper limit of normal (ULN), or haptoglobin below the lower limit of normal, or indirect bilirubin above the ULN AND
- •c.Serological evidence of anti-erythrocyte antibodies associated with a DAT that is either positive for IgG only or is positive for IgG and C3d (fragment of the third component of complement) at screening.
- •3.Has been diagnosed with wAIHA for at least 3 months, and currently receiving or has previously received treatment for wAIHA (treatment naive patients not eligible)
- •4.If on corticosteroids, the dose must be stable for at least 14 days prior to randomization.
- •5.If currently receiving immunosuppressants, treatment must be stable for 30 days prior to Screening. Allowed concomitant immunosuppressants are azathioprine, mycophenolate mofetil/mycophenolic acid, cyclosporine, cyclophosphamide.
- •6.Have a platelet count =30 × 109/L.
- •7.Have a negative QuantiFERON®-TB Gold test.
- •8.Patients who have undergone splenectomy must be at least 3 months post resection prior to screening and must be vaccinated as per the United States Center for Disease Control and Prevention (CDC) annual Recommended Immunization Schedule for Adults Aged 19 Years or
- •Older, United States
- •9.Patients with other autoimmune disease (eg, systemic lupus erythematosus or rheumatoid arthritis) or lymphoproliferative disorders may be eligible if they are stable (no changes in concomitant disease-related medications and severity of disease for at least 3 months prior to screening). Patients with lymphoproliferative disease must have a low grade, be stable and be, in the opinion of the Investigator, unlikely to require chemotherapy or monoclonal antibody therapy during the study.
- •Patients requiring change of treatment or new treatment (but not rescue therapy for wAIHA) during the study will be terminated from the study
- •10.Have sufficient venous access to allow drug administration by IV infusion and blood sampling as per the protocol.
- •11.Women of childbearing potential, defined as women physiologically capable of becoming pregnant, must have a negative serum pregnancy test at screening and a negative urine pregnancy test at Baseline.
- •Menopausal women must have an elevated serum follicle-stimulating hormone (FSH) level at Screening; if the FSH is not elevated, they are considered to be of childbearing potential and must have a negative serum pregnancy test at screening and a negative urine pregnancy test at Baseline to be eligible.
- •12.Women of childbearing potential (including menopausal women who do not have elevated FSH) must agree to remain totally abstinent (ie, refrain from sexual intercourse during the study) or to consistently use a reliable and highly effective method of contraception (eg, condom plus diaphragm, condom plus spermicide, diaphragm plus spermicide, or intrauterine device or oral/injectable/implanted hormonal contraceptive used in combination with an additional barrier method) during the study and for 30 days after the last study treatment.
- •(for the complete list, please refer to the attached Protocol synopsis)
- •Inclusion criteria-Open-Label Extension
- •1.Have completed the double-blind period (throu
排除标准
- •Exclusion Criteria - Double blind period
- •1. Are currently taking IgG Fc-related protein therapeutics
- •2.Have received a transfusion within 30 days prior to randomization.
- •3.Have any other associated cause of hereditary or acquired hemolytic anemia.
- •4.Have received rituximab within 3 months prior to screening.
- •5.Have received IVIg within 6 weeks prior to screening.
- •6.Have cold antibody AIHA, cold agglutinin syndrome, mixed type (ie, warm and cold) AIHA, or paroxysmal cold hemoglobinuria.
- •7.Have a severe infection (eg, pneumonia, biliary tract infection, diverticulitis, Clostridium difficile infection) that requires parenteral anti-infectives and/or hospitalization, and/or is assessed as
- •serious/clinically significant by the Investigator, within 8 weeks prior to screening. Any patient with an infection requiring oral antiinfectives (eg, sinusitis, bronchitis, uncomplicated urinary tract infection) within 4 weeks prior to screening will be excluded.
- •8.Have a chronic infection (eg, bronchiectasis, chronic osteomyelitis, chronic pyelonephritis) or require chronic treatment with anti-infectives (eg, antibiotics, antivirals).
- •9.Have received a live vaccine within 3 months prior to screening, or have a known need to receive a live vaccine during the study or within at least 3 months after the last dose of study drug.
- •10. Have any confirmed or suspected clinical immunodeficiency syndrome not related to treatment of his/her wAIHA, or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the patient.
- •11.Have a known history of, or positive test result for human immunodeficiency virus-1 (HIV 1) and HIV 2 antibodies, hepatitis B virus (HBV core antigen), or hepatitis C virus (HCV) at screening.
- •Note: Patients with past HCV may be included in the study if they have a documented negative HCV ribonucleic acid level in the serum at 12 weeks or longer after the completion of HCV therapy and at screening.
- •Patients with spontaneous resolution of HCV (as confirmed by specialist) may be included in the study if they demonstrate a negative serum HCV ribonucleic acid level
- •12.Are currently breastfeeding, pregnant, intend to become pregnant during the study, or are planning egg donation during the study or within 30 days after the last dose of study drug.
- •13.Have current alcohol/substance abuse/dependence, a history of alcohol/substance abuse/dependence within the 12 months prior to screening, or, in the Investigator's opinion, show evidence of ongoing alcohol/substance abuse/dependence.
- •14.Are currently participating in another interventional clinical trial or have received any investigational drug within the past 3 months prior to screening.
- •15.Have had any major surgery within 3 months prior to screening or have plans for or have been scheduled for any elective surgery or major dental procedure during the study.
- •16.Have a history of a major organ transplant (eg, heart, lung, kidney, liver), or hematopoietic stem cell/marrow transplant.
- •(for the complete list, please refer to the attached Protocol synopsis)
- •Exclusion Criteria - Opel Label Extension
- •1. Met any of the stopping criteria (see Section 6.4.1 of the protocol) or discontinued study drug during the double-blind period due to treatment-related AE.
- •2. Currently have a serious or clinically significant infection (eg, pneumonia, biliary tract infection, diverticulitis, C. difficile infection) requiring parenteral anti-infectives and/or hospitalization.
- •The following
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