EUCTR2019-000720-17-GR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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 148
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
- •Double blind period
- •1.Participants =18 years of age.2. Diagnosed with active primary or secondary wAIHA, defined as:
- •a. Hgb value<10 g/dL AND b. Signs of hemolysis, defined as: lactate dehydrogenase (LDH) levels
- •above upper limit of normal (ULN), or haptoglobin below lower limit of normal, or indirect bilirubin above 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+C3d at screening. DAT: negative, can be repeated once. If negative, participant not eligible.3.Diagnosed with wAIHA for at least 3 months, and currently receiving or previously received treatment for wAIHA (treatment naive participants not eligible) 4.If on corticosteroids, participants must have been on treatment for at least 4 weeks with a stable dose during the screening period or for at least 14 days prior to randomization, whichever is longer. Note:Investigators can optimize the above background medications prior to randomization if they are following the above rules for stable dose duration.5. If receiving immunosuppressants, following drugs allowed:concomitant immunosuppressants are azathioprine, mycophenolate
- •mofetil/mycophenolic acid, methotrexate, cyclosporine, tacrolimus,danazol, and cyclophosphamide. Participants on stable dose of these drugs for =12 weeks prior screening and during the screening period. If stopped, for at least 8 weeks prior to screening. Note: Investigators can optimize the above background medications prior to randomization if they are following the above rules for stable dose duration. 6.Have a platelet count =30 × 10E9/L.
- •7.Participants who have undergone splenectomy must be at least 3
- •months post resection prior screening and must be vaccinated as per the
- •US Center for Disease Control and Prevention annual Recommended
- •Immunization Schedule for Adults Aged 19 Years or Older, US
- •8.Participants with other autoimmune disease 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). Participants with lymphoproliferative disease must
- •have a low grade, be stable and be, unlikely to require chemotherapy or
- •monoclonal antibody therapy during the double blind period of the study.
- •Participants requiring change of treatment or new treatment for
- •autoimmune or lymphoproliferative diseases (but not rescue therapy for
- •wAIHA) during the DBP will be terminated from the study.
- •9.Have sufficient venous access to allow drug administration by IV
- •infusion and blood sampling as per the protocol.
- •10.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 FSH level at
- •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.
- •11.Women of childbearing potential (including menopausal women who
- •do not have elevated FSH) must agree to remain totally abstinent (i.e.,
- •refrain from sexual intercourse during the study) or to consistently use a
- •reliable and highly effective method of contraception during the study
- •and for 30 days after the last dose of
- •12. Male participants must wear a condom when en
排除标准
- •Double blind period
- •1. Are currently taking IgG Fc-related protein therapeutics.
- •2.Have received transfusion within 30 days prior to randomization.
- •3.Have any other associated cause of hereditary or acquired hemolytic
- •4.Have received rituximab within 3 months prior to screening.
- •5.Have received IVIg within 6 weeks prior to screening.
- •6.Have been diagnosed with cold antibody AIHA, cold agglutinin
- •syndrome, mixed type (ie, warm and cold) AIHA, or paroxysmal cold
- •hemoglobinuria.
- •7.Have a severe 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 participant
- •with an infection requiring oral antiinfectives within 4 weeks prior to
- •screening will be excluded.
- •8.Have a chronic infection or require chronic treatment with anti-
- •infectives.
- •9.Have received a live viral or bacterial vaccine within 4 weeks prior to
- •first dose of study drug, or have a known need to receive a live viral or
- •bacterial vaccine during the study or within at least 8 weeks after the
- •last dose of study drug. For information regarding the Bacille CalmetteGuérin (BCG) vaccine, please see Exclusion Criterion
- •10. Have any confirmed or suspected clinical immunodeficiency
- •syndrome not related to treatment of their wAIHA, or has a family
- •history of congenital or hereditary immunodeficiency unless confirmed
- •absent in the
- •participant.
- •11. Have any of the following viral testing outcomes: A history of HIV
- •infection or positive test result for HIV-1 and HIV 2 antibodies; positive
- •test for hepatitis B virus surface antigen. For participants with a
- •negative test for HBsAg along with a positive test for anti-hepatitis B
- •core antibodies and a positive or negative test for anti-HBs antibodies,
- •hepatitis B viral DNA detection will be performed. Participants with a
- •positive hepatitis B viral DNA detection will be excluded. If HBV DNA
- •testing cannot be performed, or there is evidence of chronic liver
- •disease, the participant is not eligible for the protocol; A positive test
- •hepatitis C virus (HCV) unless 1 of the following conditions are met: (a)
- •Has a history of successful treatment, defined as being negative for HCV
- •RNA at least 24 weeks after completing antiviral treatment, and has a
- •negative HCV RNA test result at screening, OR (b) -Has a negative HCV
- •RNA test result at least 24 weeks prior to screening and a negative HCV
- •RNA test at the
- •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
- •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
- •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
- 另有 7 项未显示
研究者
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