EUCTR2021-003302-50-AT进行中（未招募）1 期
A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group, Multicenter Trial to Evaluate the Safety and Tolerability, Efficacy, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of 2 Dose Regimens of ARGX-117 in Adults With Multifocal Motor Neuropathy - ARDA
适应症
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
- 48
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
- •1. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol (including consent for the use and disclosure of research related health information). Participants must be able to read and write and be willing and able to comply with the trial protocol procedures (including attending the required trial visits)
- •2. Male/female at least 18 years of age at the time the ICF is signed
- •3. Probable or definite MMN according to the EFNS/PNS 2010 guidelines at screening confirmed by the MCC
- •4.1. Receiving a stable IVIg regimen for at least 3 months before screening or recently initiated IVIg treatment (refer to inclusion criterion 5.1a), AND both of the following:
- •a) IVIg treatment interval of 2 to 5 weeks
- •b) IVIg dose of 0.4 to 2.0 g per kg body weight and infusion
- •5.1. IVIg treatment dependency confirmation by the MCC at screening or after IVDP when applicable, based on 1 of the following:
- •a) Recently initiated IVIg treatment (less than 3 months):
- •- Clinical improvement following IVIg initiation documented in the participant’s medical record
- •b) Maintenance therapy with IVIg (longer than 3 months), based on 1 of the following:
- •- Clinical deterioration following IVIg withdrawal, IVIg dose reduction, or IVIg delayed administration within 12 months prior to screening (documented in the participant’s medical record)
- •- Clinical deterioration following IVIg delayed administration during the IVDP
- •6. Immunization with the first meningococcal vaccine and pneumococcal vaccine, and the single Haemophilus influenza type B vaccine must be performed at least 14 days before IMP administration at V1 according to local country-specific immunization schedules. A documented history of vaccination against Neisseria meningitides, Haemophilus influenza type B, and streptococcus pneumonia will be permitted
- •7. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
- •a) Male participants must agree to not donate sperm from the time the ICF is signed until 15 months after the last IMP administration
- •b) Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline before IMP can be administered
- •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 36
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
排除标准
- •1. Any coexisting condition which may interfere with the outcome assessments (eg, diabetic neuropathy, CIDP, inflammatory arthritis, or osteoarthritis affecting the hand)
- •2. Clinical signs or symptoms suggestive for neuropathies other than MMN such as motor neuron disease (eg, bulbar signs or brisk reflexes) or other inflammatory neuropathies (eg, sensory neuropathy)
- •3. Severe psychiatric disorder (such as severe depression, psychosis, bipolar disorder), history of suicide attempt, or current suicidal ideation that in the opinion of the investigator could create undue risk to the participant or could affect adherence with the trial protocol.
- •4. Clinically significant uncontrolled active or chronic bacterial, viral, or fungal infection during the screening and/or IVMP.
- •5. Any other known autoimmune disease that, in the opinion of the investigator, would interfere with an accurate assessment of clinical symptoms of MMN or put the participant at undue risk (eg, SLE).
- •6. History of malignancy unless resolved by adequate treatment with no evidence of recurrence for =3 years before the first administration of the IMP. Participants with the following carcinomas will be eligible:
- •a. Adequately treated 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 (TNM stage T1a or T1b)
- •7. Clinical evidence of other significant serious diseases, have had a recent major surgery, (including splenectomy at any time), or who have any other condition in the opinion of the investigator, that could confound the results of the trial or put the participant at undue risk
- •8. Prior/concomitant therapy
- •a. Cyclophosphamide and/or rituximab and/or eculizumab and/or mycophenolate mofetil within 3 months prior to screening
- •b. Use of an investigational product within 3 months or 5 half-lives (whichever is longer) before the first dose of the IMP.
- •9. Positive serum test at screening for an active viral infection with any of the following conditions:
- •a. Hepatitis B virus (HBV) that is indicative of an acute or chronic infection (https://www.cdc.gov/hepatitis/HBV/PDFs/SerologicChartv8.pdf)
- •b. Hepatitis C virus (HCV) based on HCV antibody assay, confirmed by HCV RNA
- •c. HIV based on test results that are associated with an AIDS-defining condition or a CD4 count <200 cells/mm3
- •10. Current or history of (ie, within 12 months of screening) alcohol, drug, or medication abuse
- •11. Known hypersensitivity reaction to 1 of the components of the IMP or any of its excipients
- •12. Female participants with a positive serum or urine pregnancy test, lactating females, and those who intend to become pregnant during the trial or within 12 months after last dose of the IMP
- •13. ALT or AST =2 × upper limit of normal and total bilirubin =1.5 × upper limit of normal of the central laboratory reference range, or any other clinically significant laboratory abnormality. These tests will be
- •performed by the central laboratory
- •14. An estimated glomerular filtration rate of =60 mL/min/1.73m2 calculated by the central laboratory using the 4-variable Modification of Diet in the Renal-Disease equation
研究者
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