NL-OMON54098招募中3 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
- 3 期
- 状态
- 招募中
- 发起方
- argenx BV
- 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
- •Participants are eligible to be included in the study only if all of the
- •following criteria apply:
- •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 protocol.
- •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 by the central laboratory.
- •During the screening or rescreening period, any historical results for AChR-Ab
- •can be used, as long as the results are <=1 year old.
- •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 (AChE)
- •inhibitors. If receiving corticosteroids and/or NSIDs, must be on a stable dose
- •for at least 1 month before screening.
- •7. Agrees to use contraceptive measures consistent with local regulations and
- •the following:
- •a. Male participants: (contraceptive measures provided in Section 10.4.2.2 of
- •the protocol, refer to Section 10.7 of the protocol for country specific
- •requirements)
- •b. WOCBP (defined in Section 10.4.1 of the protocol) must have a negative serum
- •pregnancy test at screening and a negative urine pregnancy test at baseline
- •before receiving IMP (Section 10.4.2.1. of the protocol, see Section 10.7 of
- •the protocol for country-specific requirements).
排除标准
- •Participants are excluded from the study if any of the following criteria
- •1. Clinically significant uncontrolled active or chronic bacterial, viral, or
- •fungal infection at screening that is not sufficiently resolved in the
- •investigator's opinion.
- •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
研究者
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