What were the goals of the ENSPRYNG clinical trials?
Two clinical trials were conducted to determine whether ENSPRYNG alone or ENSPRYNG in combination with immunosuppressive therapy (IST) could lower the risk of relapse in adults with NMOSD vs placebo. ISTs may stop some activity in your body’s immune system, and can include azathioprine, mycophenolate mofetil, or oral corticosteroids. Both trials also measured how many patients were relapse-free at specific time points with treatment.
How was ENSPRYNG studied?
Patients from countries around the world participated in the 2 trials.
A wide range of patients in terms of age, gender, AQP4-IgG status, and severity of disease were represented in the clinical trials:
- Men and women, with a larger proportion of women
- Patients who were AQP4-IgG(+) or AQP4-IgG(–)
- Patients with at least 1 confirmed relapse over the past year
Study 1 excluded patients who were recently taking other treatments before starting the trial. The study included 95 patients who were AQP4-IgG(+) or AQP4-IgG(–) to randomly receive either ENSPRYNG or placebo. Of the 64 who were AQP4-IgG(+), 41 patients received ENSPRYNG and 23 patients received placebo.
Study 2 only included patients who were taking certain ISTs (azathioprine, mycophenolate mofetil, or oral corticosteroids) before starting the trial. The study included 76 patients who were AQP4-IgG(+) or AQP4-IgG(–) to randomly receive either ENSPRYNG plus IST or placebo plus IST. Of the 52 who were AQP4-IgG(+), 26 patients received ENSPRYNG and 26 patients received placebo.