EUCTR2021-002504-12-IT进行中（未招募）1 期
A Phase 3b, Randomized, Open-label, Parallel-Group Study to Evaluate Different Dosing Regimens of Intravenous Efgartigimod to Maximize and Maintain Clinical Benefit in Patients With Generalized Myasthenia Gravis (gMG) - ADAPT NXT
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
- 72
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 as described in Section
- •10.1.3 of the protocol, which includes compliance with the requirements
- •and restrictions listed in the informed consent form (ICF) and in this
- •2. At least 18 years of age, at the time of signing the informed consent
- •3. Diagnosed with gMG with confirmed documentation and supported by
- •a physical exam and confirmed seropositivity for AChR-Abs
- •4. Meets the clinical criteria as defined by the Myasthenia Gravis
- •Foundation of America (MFGA) class II, III, or IV
- •5. Has an MG-ADL total score =5 at screening and the day 1 visit, with
- •more than 50% of the score due to nonocular symptoms
- •6. Concomitant gMG treatment is permitted. Permitted concomitant gMG
- •treatment includes nonsteroidal immunosuppressive drugs (NSIDs),
- •steroids, and/or acetylcholinesterase (AChE) inhibitors. If receiving
- •corticosteroids and/or NSIDs, must be on a stable dose for at least 1
- •month before screening.
- •7. Contraceptive use by men and women should be consistent with local
- •regulations regarding the methods of contraception for those participating in clinical studies and:
- •a. Male participants:
- •- Male participants are not allowed to donate sperm from signing the
- •ICF until the end of the study.
- •b. Female participants:
- •- WOCBP (defined in Section 10.4.1 of protocol) must have a negative
- •serum pregnancy test at screening and a negative urine pregnancy test
- •at baseline before IMP can be administered.
- •- The contraception requirements for WOCBP are described in Section
- •10.4.2.1 of 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 43
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 29
排除标准
- •1. Clinically significant uncontrolled active or chronic bacterial, viral, or
- •fungal infection at screening
- •2. A positive test for SARS-CoV-2 at screening
- •3. Any other known autoimmune disease that, in the opinion of the
- •investigator, would interfere with an accurate assessment of the clinical
- •symptoms of gMG and/or put the participant at undue risk
- •4. History of malignancy unless deemed cured by adequate treatment
- •with no evidence of reoccurrence for =3 years before the first
- •administration of the IMP. Participants with the following cancers can be
- •included at any time, provided they are adequately treated at screening:
- •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 (TNM stage T1a or
- •5. Clinical evidence of other significant serious diseases, a recent (<3
- •months) major surgery, or any other condition that, in the opinion of the
- •investigator, could confound the results of the study or put the
- •participant at undue risk
- •6. A thymectomy within 3 months of screening
- •7. Pregnant or lactating females and those who intend to become
- •pregnant during the study or within 90 days of the last dose of IMP
- •8. Use of the following prior or concomitant therapies:
- •a. IVIg or subcutaneous (SC)Ig within 14 days of day 1
- •b. Rituximab within 6 months of day 1
- •c. Eculizumab within 1 month of day 1
- •d. Other monoclonal antibodies (eg, adalimumab, tocilizumab,
- •ixekizumab) within 5 half-lives of the monoclonal antibodies before day
- •e. Use of any other investigational product within 3 months or 5 halflives,
- •whichever is longer, before day 1
- •f. Receipt of a live or live-attenuated vaccine within 4 weeks of
- •screening. The receipt of any inactivated, subunit, polysaccharide,
- •conjugate vaccine at any time before screening is not considered
- •exclusionary.
- •9. Previous participation in a clinical study or patient access program
- •during which they were treated with efgartigimod
- •10. Positive serum test at screening for an active viral infection with any
- •of the following conditions:
- •a. Hepatitis B virus (HBV) that is indictive of an acute or chronic
- •b. Hepatitis C virus (HCV) based on HCV antibody assay (unless
- •associated with a negative HCV RNA test)
- •c. HIV based on test results that are associated with an AIDS-defining
- •condition or a CD4 count =200 cells/mm3
- •11. Total IgG <6 g/L at screening
- •12. Known hypersensitivity reaction to efgartigimod or any of its excipients
- •13. The participant stands in any relationship of dependency with the
- •14. The participant has been institutionalized due to an official or judicial
研究者
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