Refer a Patient
Have a Patient with Generalized Myasthenia Gravis (gMG) Who May Be Interested in the Prevail Study?
The Prevail Study is a phase 3, randomized, double-blind, placebo-controlled, parallel, multicenter study. Approximately 200 participants will be enrolled in this study.
The total duration of participation can last approximately up to 34 months (a little over 2.5 years) and consists of a screening period (up to 4 weeks), a randomized controlled treatment period (26 weeks), and an open-label extension period (up to 105 weeks). All participants must attend an in-person visit 12 weeks after receiving the final treatment dose. The safety follow-up (SFU) visit is required whether a participant withdraws early from the study or completes the open-label extension period.
During the randomized controlled treatment period, participants will be assigned in a 1:1 ratio to receive either the study medication, gefurulimab (ALXN1720) or a placebo through a single-use, prefilled syringe with a needle safety device. During the open-label extension period, all participants will receive ALXN1720. Both ALXN1720 and the placebo will be administered via subcutaneous injection on a weekly basis.
The primary objective of the Prevail Study is to assess the efficacy of ALXN1720 compared to placebo in the treatment of gMG based on change from baseline measured by the Myasthenia Gravis Activities of Daily Living (MG-ADL) total score. This new investigational therapy differs from current pharmacological options, as it can be administered through subcutaneous injection with a prefilled syringe by the participant or a caregiver.
Key Inclusion Criteria
- 18 years of age or older
- Documented diagnosis of gMG ≥ 3 months
- Positive serological test for acetylcholine receptor (AChR) autoantibodies
- Myasthenia Gravis Foundation of America (MGFA) Classification II to IV
Key Exclusion Criteria
- Any medical condition (e.g., cardiac, pulmonary, renal, oncologic, neurological, or psychiatric disorder) or risk factor that might interfere with study participation or patient safety
- History of thymectomy or any other thymic surgery within past 12 months
- Any untreated thymic malignancy, carcinoma, or thymoma
- History of N. meningitidis infection
- Pregnant, breastfeeding, or intending to conceive during the course of the study
There are additional eligibility requirements, which the study team can explain to interested individuals.