EUCTR2021-001277-23-FR进行中（未招募）1 期
A Phase 2/3, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group, 2-Arm, Multicenter, Operationally Seamless Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Efgartigimod PH20 SC in Participants Aged 18 Years and Older With Active Idiopathic Inflammatory Myopathy - alkivia
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- argenx BV
- 入组人数
- 240
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
- 性别
- All
入选标准
- •Ability to consent in the jurisdiction in which the study is taking place and capable of giving signed informed consent.
- •A definite or probable clinical diagnosis of idiopathic inflammatory myopathy (IIM)
- •One of the following medical histories:
- •a. Diagnosis of dermatomyositis (DM) or juvenile dermatomyositis (JDM), (age of disease onset <18 years of age). The diagnosis date for juvenile dermatomyositis should not be >5 years from the screening date.
- •b. Diagnosis of polymyositis (PM) (including antisynthetase syndrome (ASyS))
- •c. Diagnosis of immune-mediated necrotizing myopathy (IMNM)
- •Diagnosed with active disease as defined by the presence of at least 1 of the following criteria:
- •a. Abnormal levels of at least 1 of the following enzymes: creatine kinase (CK), aldolase, lactate dehydrogenase, aspartate aminotransaminase (AST), alanine aminotransferase (ALT), based on central laboratory results
- •b. Electromyography demonstrating active disease within the past 3 months
- •c. Active dermatomyositis (DM) skin rash
- •d. Muscle biopsy indicative of active idiopathic inflammatory myopathy (IIM) in the past 3 months
- •e. Magnetic resonance imaging within the past 3 months indicative of active inflammation
- •Muscle weakness
- •Receiving a permitted background treatment for idiopathic inflammatory myopathy. Permitted background treatment includes: oral corticosteroids; 1 antimalarial; or 1 of the following immunosuppressants: methotrexate, azathioprine, mycophenolate mofetil, mycophenolic acid, tacrolimus, cyclosporine, leflunomide, or mizoribine. Participants may receive a combination of either oral corticosteroids and up to 1 antimalarial or oral corticosteroids and up to 1 immunosuppressant.
- •Contraceptive use by nonsterilized male participants and women of childbearing potential will be consistent with local regulations, where available, for individuals participating in clinical studies. Women of childbearing potential must have a negative serum pregnancy test during screening and a negative urine pregnancy test at baseline to establish the nonpregnant state before receiving investigational medicinal product (IMP).
- •The full list of inclusion criteria can be found in the protocol.
- •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 220
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •A clinically significant uncontrolled active or chronic bacterial, viral, or fungal infection at screening
- •A COVID-19 polymerase chain reaction (PCR)-positive test before enrollment
- •Any other known autoimmune disease that, in the investigator’s opinion, would interfere with an accurate assessment of clinical symptoms of idiopathic inflammatory myopathy (IIM) or put the patient at undue risk
- •A history of malignancy unless considered cured by adequate treatment, with no evidence of recurrence for = 3 years before the first administration of the investigational medicinal product (IMP). Adequately treated participants with the following cancers can be included at any time:
- •a. Basal cell or squamous cell skin cancer
- •b. Carcinoma in situ of the cervix
- •c. Carcinoma in situ of the breast
- •d. Incidental histological finding of prostate cancer
- •Severe muscle damage
- •Glucocorticoid-induced myopathy that the investigator considers the primary cause of muscle weakness or permanent weakness linked to a non-idiopathic inflammatory myopathy (IIM) cause
- •Juvenile myositis (JDM) diagnosed > 5 years from screening or juvenile myositis with extensive calcinosis or severe calcinosis.
- •Uncontrolled interstitial lung disease or any other uncontrolled idiopathic inflammatory myopathy (IIM) manifestation that, in the opinion of the investigator, would be likely to require treatment with prohibited medication during the study
- •Other inflammatory and noninflammatory myopathies: inclusion body myositis, overlap myositis), metabolic myopathies, muscle dystrophies or a family history of muscle dystrophy, drug-induced or endocrine induced myositis, and juvenile myositis (other than juvenile dermatomyositis (JDM))
- •Clinically significant disease, recent major surgery or intends to have surgery during the study, or has any other condition in the opinion of the investigator that could confound the results of the study or put the patient at undue risk
- •Known hypersensitivity reaction to investigational medicinal product (IMP) or 1 of its excipients
- •Received a live or live-attenuated vaccine less than 4 weeks before screening.
- •Lack of clinical response to plasmapheresis/plasma exchange (PLEX)
- •Positive serum test at screening for active viral infection with any of the following conditions:
- •a. Hepatitis B virus (HBV)
- •b. Hepatitis C virus (HCV)
- •Any of the following prior therapy or procedures:
- •a. Treatment within 2 weeks before screening: topical corticosteroids or topical immunomodulators (eg, tacrolimus) for idiopathic inflammatory myopathy (IIM) rash
- •b. Treatment within 4 weeks before screening: local corticosteroid injections, anakinra, etanercept, Janus kinase (JAK) inhibitors, corticosteroids, plasmapheresis/plasma exchange, immunoadsorption
- •c. Treatment within 8 weeks before screening: corticosteroid precursors
- •d. Treatment within 12 weeks before screening: IVIg, SCIg, tocilizumab, abatacept, infliximab, adalimumab, golimumab, certolizumab, ustekinumab
- •e. Treatment within 24 weeks before screening: rituximab or other anti-CD20 antibody, cyclophosphamide
- •f. Use of a nonbiologic investigational product within 12 weeks before screening
- •g. Use of a biologic therapy and/or monoclonal antibody within 24 weeks before screening
- •h. Treatment with oral corticosteroids
- •i. Treatment with >1 immunosuppressant, >1 antimalarial, or a combination of an immunosuppressant and an antimalarial
- •Participant has previously participated in an efgartigimo
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