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 - MOM-M281-006

Janssen-Cilag International NV0 个研究点目标入组 6 人开始时间: 待定最近更新: 2024年9月9日

适应症

试验速览

阶段: 2 期
状态: 招募中
发起方: Janssen-Cilag International NV
入组人数: 6

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

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研究设计

研究类型: Interventional

入排标准

年龄范围: 18 至 99（—）

入选标准

•Inclusion Criteria, Double-blind Period
•Patients who meet the following criteria will be eligible for enrollment into
•the double-blind period of the study.
•1. Male or female >=18 years of age.
•2. Diagnosed with active primary or secondary wAIHA, defined as having all of
•the following:
•a) Hgb value<10 g / dl 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 at the central laboratory.
•If the DAT is negative, it can be repeated once. If the repeat is negative,
•participant not eligible.
•3. Have been diagnosed with wAIHA for at least 3 months, and are currently
•receiving treatment for wAIHA OR have previously received treatment for wAIHA
•(treatment-naïve participants are 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 must have
•been on a stable dose of any of
•these drugs for =12 weeks prior to screening and during the screening period.
•If any of these drugs were stopped,
•it must have been 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 × 109/L.
•Note: Patients with Evans syndrome who do not have primary immunodeficiency
•will be eligible as long as they meet all other entry criteria, including
•having a platelet count >=30 × 109/L.
•7. Participants 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
•(https://www.cdc.gov/vaccines/schedules/hcp/imz/adult-conditions.html) OR must
•be vaccinated as per country-specific guidelines (Davies 2011).
•8. Participants with other autoimmune disease (e.g., 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.
•Participants with lymphoproliferative disease must also have a low grade, be
•stable and be, in the opinion of the Investigator, unlikely to require
•chemotherapy or monoclonal antibody therapy during the double-blind period of
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排除标准

•Exclusion Criteria, Double-blind Period
•Patients who meet any of the following criteria will not be eligible for
•enrollment into the double-blind period of the study.
•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 been diagnosed with cold antibody AIHA, cold agglutinin syndrome, mixed
•type (i.e., warm and cold) AIHA, or paroxysmal cold hemoglobinuria.
•7. Have a severe infection (e.g., pneumonia, biliary tract infection,
•diverticulitis, Clostridium difficile infection) that requires parenteral
•anti-infectives and/or hospitalization, and/or is assessed as
•serious/clinically significant (CS) by the Investigator, within 8 weeks prior
•to screening. Any participant with an infection requiring oral anti-infectives
•(e.g., sinusitis, bronchitis, uncomplicated urinary tract infection) within 4
•weeks prior to screening will be excluded.
•8. Have a chronic infection (e.g., bronchiectasis, chronic osteomyelitis,
•chronic pyelonephritis) or require chronic treatment with anti-infectives
•(e.g., antibiotics, antivirals).
•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 3 months after the last
•dose of study drug. For information regarding the Bacille Calmette-Guérin (BCG)
•vaccine, please see Exclusion Criterion 25.
•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 human immunodeficiency virus (HIV) infection or positive test
•result for HIV-1 and HIV 2 antibodies.
•A positive test for hepatitis B virus surface antigen (HBsAg). For
•participants with a negative test for HBsAg along with a positive test for
•anti-hepatitis B core (HBc) 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 for
•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 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 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 <

研究者

发起方

Janssen-Cilag International NV

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