EUCTR2021-003302-50-IT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
相关药物
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
- •at screening confirmed by the MCC
- •3. Probable or definite MMN according to the EFNS/PNS 2010 guidelines
- •at screening confirmed by the MCC
- •4. Receiving a stable IVIg regimen before screening and both of the
- •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. IVIg treatment dependency confirmation by the MCC at screening or
- •at IMV1, 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
- •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 12 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
- •7. Clinical evidence of other significant serious diseases, have had a
- •recent major surgery, 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
- •(https://www.cdc.gov/hepatitis/HBV/PDFs/SerologicChartv8.pdf)
- •b. Hepatitis C virus (HCV) based on HCV antibody assay
- •c. HIV based on test results that are associated with an AIDS-defining
研究者
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