NL-OMON51964已完成2 期
A multicenter, open-label, non-randomized, Phase 1b/2 study to evaluate the safety, pharmacokinetics, and efficacy of subcutaneous isatuximab in adults with warm autoimmune hemolytic anemia - ACT16832
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 2
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Participant must be >=18 to years of age, inclusive, at the time of signing the
- •informed consent.
- •- Males and females with a confirmed diagnosis of primary w AIHA or systemic
- •lupus erythematosus (SLE)-associated wAIHA (without other SLE-related
- •manifestations apart from cutaneous and musculoskeletal manifestations) who
- •meet the following criteria:
- •a) Hemoglobin level <10 g/dL at screening.
- •b) Hemolysis (haptoglobin <=40 mg/dL and total or indirect/unconjugated
- •bilirubin above the upper limit of normal).
- •c) Positive direct antiglobulin test (DAT) (IgG or IgG + complement C3d pattern
- •or IgM warm autoantibodies (positive dual DAT)).
- •- Participants who have previously failed to maintain a sustained response
- •after treatment with corticosteroids (corticosteroid-refractory or
- •corticosteroid-dependent primary wAIHA).
- •- Part A only: Participants who have previously failed to maintain a sustained
- •response after treatment with rituximab (or other anti-CD20 monoclonal
- •antibodies). The last dose of the anti-CD20 antibody must have been
- •administered at least 12 weeks before enrollment.
- •- Part B: Participants who have had an insufficient response to at least 1
- •prior therapy in addition to corticosteroids (splenectomy is regarded as a
- •prior therapy).
- •- Contraceptive use by men and women.
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •- Clinically significant medical history or ongoing chronic illness that would
- •jeopardize the safety of the participant or compromise the quality of the data
- •derived from his or her participation in the study as determined by the
- •Investigator.
- •- Serious infection that required hospitalization within 3 months prior to
- •enrollment.
- •- Secondary wAIHA from any cause including drugs, lymphoproliferative
- •disorders, infectious or autoimmune disease (SLE without other SLE-related
- •manifestations apart from cutaneous and musculoskeletal manifestations is
- •allowed), or active hematologic malignancies. Participants with positive
- •antinuclear antibodies but without a definitive diagnosis of an autoimmune
- •disease are allowed.
- •- History of coagulation or bleeding disorders (Evans Syndrome is allowed).
- •- Uncontrolled or active HBV or HCV infection.
- •- HIV infection.
- •- Serum gammaglobulin levels <3 g/L.
- •- Females who are pregnant, lactating, or considered unreliable with respect to
- •contraceptive practice.
- •- Concurrent treatment with corticosteroids, unless the participant has been on
- •a stable daily dose for >= 15 days prior to enrollment.
- •- Treatment with cyclophosphamide within 4 weeks prior to enrollment.
- •- Treatment with cytotoxic drugs (other than cyclophosphamide) within 12 weeks
- •prior to enrollment.
- •- Treatment with non-cytotoxic, immunomodulatory drugs (including but not
- •limited to Cyclosporine, Sirolimus, Tacrolimus, Idelalisib, Ibrutinib),
- •excluding biologic agents, within 4 weeks prior to enrollment.
- •- Treatment with any biologic agent within 12 weeks prior to enrollment.
研究者
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