A study to examine the efficacy and safety of pozelimab and cemdisiran combination therapy in patients with symptomatic Generalized Myasthenia Gravis

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Male or female patients greater than or equal to 18 years of age at screening (or greater than or equal to 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 percent ofMG-ADL total score

6.Currently receiving an acetylcholinesterase inhibitor or documented reason for not using acetylcholinesterase inhibitor therapy perinvestigator

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).

9.Note- Other protocol-defined Inclusion Criteria apply

Exclusion Criteria

1.Patients with antibody profile that is only positive for muscle specific tyrosine kinase (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.No documented meningococcal vaccination within 5 years prior to screening visit unless vaccination will be administered during the screening period and prior to initiation of study treatment

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. NOTE: Cases with unclear interpretation should be discussed with the medical monitor

9.History of HIV infection or a positive test at screening per local requirements

10.Note- Other protocol-defined Exclusion Criteria apply

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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