EUCTR2020-003272-41-BE招募中1 期
Efficacy and Safety of Pozelimab and Cemdisiran Combination Therapy and Cemdisiran Monotherapy in Patients with Symptomatic Generalized Myasthenia Gravis - NIMBLE
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 235
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
- •1. Male or female patients =18 years of age at screening (or = legal age of adulthood based on local regulations, whichever is older)
- •2. Patient with documented diagnosis of myasthenia gravis (MG) based on medical history and supported by previous evaluations as described in the protocol
- •3. Documented prior history of positive serologic test or a positive result during screening of anti-acetylcholine receptor (AChR) antibodies or anti-LRP4 antibodies.
- •4. Myasthenia Gravis Foundation of America (MGFA) Clinical Classification Class II to IVa at screening
- •5. Myasthenia Gravis-Activities of Daily Living (MG-ADL) score =6 at screening. Ocular items should not contribute more than 50% of MG-ADL total score
- •6. Currently receiving an acetylcholinesterase inhibitor or documented reason for not using acetylcholinesterase inhibitor therapy per investigator
- •7. Currently receiving an immunosuppressive therapy (IST) for MG, or documented reason why the patient is not taking an IST per investigator
- •8. If currently receiving an IST, not anticipated to have IST dosage changed before randomization or during double-blind treatment period (DBTP).
- •NOTE: Other Inclusion Criteria apply
- •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 223
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
排除标准
- •1. Patients with antibody profile that is only positive for MuSK (MuSK positivity is based on a documented prior history of positive serologic test for antibodies to MuSK or a positive result during screening)
- •2. History of thymectomy within 12 months prior to screening or planned during the study
- •3. History of malignant thymoma (patients with stage 1 may be enrolled), or history of cancer within the past 5 years, except for adequately treated basal cell skin cancer, squamous cell skin cancer, or in situ cervical cancer
- •4. Myasthenic crisis or Myasthenia Gravis Foundation of America (MGFA) Class V within 1 month of screening
- •5. Not meeting meningococcal vaccination requirements and, at a minimum, documentation of quadrivalent meningococcal vaccination within 5 years prior to the screening visit and serotype B vaccine within 3 years prior to the screening visit as described in the protocol
- •6. Known contraindication to meningococcal vaccines (group ACWY conjugate and group B vaccines) as described in the protocol
- •7. Patients who require antibiotics for meningococcal prophylaxis and have a contraindication, warning, or precaution precluding the use of penicillin class and penicillin-alternative antibiotics planned to be used for prophylaxis, or a history of intolerance leading to the discontinuation of these antibiotics
- •8. Positive hepatitis B surface antigen or hepatitis C virus ribonucleic acid (RNA) during screening.
- •9. History of HIV infection or a positive test at screening per local requirements
- •NOTE: Other Exclusion Criteria apply
研究者
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