Last updated on July 2019

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients with Generalized Myasthenia Gravis IND 140,115 STUDY NUMBER: ALXN1210-MG-306


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Myasthenia Gravis generalised | Multiple Sclerosis
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

 

Patients are eligible to be included in the study only if all of the following criteria apply:

  • Male and female patients must be aged ≥ 18 years of age at the time of signing the informed consent Type of Patient and Disease Characteristics
  • Diagnosed with MG at least 6 months (180 days) prior to the date of the Screening Visit, as confirmed by protocol-specific criteria (see below)
  • Diagnosis of MG must be made by the following tests:
    • Positive serologic test for anti-AChR Abs as confirmed at screening, and
    • One of the following:
      • History of abnormal neuromuscular transmission test demonstrated by single-fiber electromyography or repetitive nerve stimulation
      • History of positive anticholinesterase test (eg, edrophonium chloride test)
      • Demonstrated improvement in MG signs on oral cholinesterase inhibitors, as assessed by the treating physician
  • Myasthenia Gravis Foundation of America Clinical Classification Class II to IV at screening
  • MG-ADL profile must be ≥ 6 at screening and randomization (Day 1)
  • Patients receiving treatment with any of the following must have been receiving treatment and on a stable dose for the time periods specified below prior to the date of the Screening Visit:
    • Azathioprine (AZA): Must have been on AZA for ≥ 6 months (180 days) and have been on a stable dose for ≥ 2 months (60 days)
    • Immunosuppressive therapies (ie, mycophenolate mofetil [MMF], methotrexate [MTX], cyclosporine [CYC], tacrolimus [TAC], or cyclophosphamide [CY]), must have been on the IST for ≥ 3 months (90 days) and have been on a stable dose for ≥ 1 month (30 days)
    • Oral corticosteroids, must have been on a stable dose for ≥ 4 weeks (28 days)
    • A cholinesterase inhibitor, at the time of the Screening Visit, must have been on a stable dose for ≥ 2 weeks (14 days)
  • To reduce the risk of meningococcal infection (N meningitidis), all patients must be vaccinated against meningococcal infections within the 3 years prior to, or at the time of, receiving a meningococcal vaccine must receive treatment with appropriate prophylactic antibiotics until 2 weeks after vaccination Weight
  • Body weight ≥ 40 kg at the time of screening Pregnancy and Contraception
  • Patients of childbearing potential and patients with partners of childbearing potential must follow protocol-specified contraception guidance (Section 10.4, Appendix 4) for avoiding pregnancy while on treatment and for 8 months after last dose of study drug Informed Consent
  • Capable of giving signed informed consent as described in Section 10.1, Appendix 1, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol

 

Patients are excluded from the study if any of the following criteria apply:

  • Any active or untreated thymoma. History of thymic carcinoma or thymic malignancy unless deemed cured by adequate treatment with no evidence of recurrence for ≥ 5 years before Screening
  • History of thymectomy within the 12 months prior to screening
  • History of hypersensitivity to any ingredient contained in the study drug, including hypersensitivity to murine proteins
  • History of N meningitidis infection
  • Human immunodeficiency virus (HIV) infection (evidenced by HIV-1 or HIV-2 antibody titer)
  • Known medical or psychological condition(s) or risk factor that, in the opinion of the Investigator, might interfere with the patient’s full participation in the study, pose any additional risk for the patient, or confound the assessment of the patient or outcome of the study
  • History of hospitalization for ≥ 24 hours, for any reason, within the 4 weeks (28 days) prior to screening
  • Clinical features that, in the opinion of the Investigator, consistent with MG crisis/exacerbation or Clinical Deterioration, at the time of the Screening Visit or at any time prior to randomization
  • Female patients who plan to become pregnant or are currently pregnant or breastfeeding
  • Female patients who have a positive pregnancy test result at screening or on Day 1 Prior/Concomitant Therapy
  • Use of the following within the time period specified below:
    • IVIg within the 4 weeks (28 days) prior to randomization (Day 1)
    • Use of PE within the 4 weeks (28 days) prior to randomization (Day 1)
    • Use of rituximab within the 6 months (180 days) prior to screening
  • Patients who have received previous treatment with complement-inhibitors (eg, eculizumab) Prior/Concurrent Clinical Study Experience
  • Participation in another interventional treatment study or use of any experimental therapy within 30 days before initiation of study drug on Day 1 in this study or within 5 half-lives of the study drug, whichever is greater

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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