A Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial of Descartes-08 in Patients With Generalized Myasthenia Gravis (MG)

Conditions

generalized myasthenia gravis

Brief summary

Proportion of participants who have a decrease of ≥3 points in MG-ADL score at Month 4 compared to Baseline in the active versus placebo group.

Detailed description

Proportion of participants who have a decrease of ≥4 points in MGC score at Month 4 compared to Baseline in the active versus placebo group., Decrease from Baseline at Month 4 in MG-ADL score in active versus placebo groups., Decrease from Baseline at Month 4 in MGC score in active versus placebo groups., Proportion of participants who have a decrease of ≥4 points in QMG score at Month 4 compared to Baseline in the active versus placebo group., Decrease from baseline in MG-ADL score at Month 2 and Month 3 follow-up in the active versus placebo group., Decrease from baseline in MGC score at Month 2 and Month 3 follow-up in the active versus placebo group., Decrease from Baseline at Month 2, Month 3 and Month 4 in QMG score in active versus placebo groups.

Related papers

No related papers found yet.

Interventions

DRUGDescartes-08

DRUGPlacebo to Descartes-08

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Secondary

Measure	Time frame
Proportion of participants who have a decrease of ≥4 points in MGC score at Month 4 compared to Baseline in the active versus placebo group., Decrease from Baseline at Month 4 in MG-ADL score in active versus placebo groups., Decrease from Baseline at Month 4 in MGC score in active versus placebo groups., Proportion of participants who have a decrease of ≥4 points in QMG score at Month 4 compared to Baseline in the active versus placebo group., Decrease from baseline in MG-ADL score at Month 2 and Month 3 follow-up in the active versus placebo group., Decrease from baseline in MGC score at Month 2 and Month 3 follow-up in the active versus placebo group., Decrease from Baseline at Month 2, Month 3 and Month 4 in QMG score in active versus placebo groups.	—

Measure

Time frame

Proportion of participants who have a decrease of ≥4 points in MGC score at Month 4 compared to Baseline in the active versus placebo group., Decrease from Baseline at Month 4 in MG-ADL score in active versus placebo groups., Decrease from Baseline at Month 4 in MGC score in active versus placebo groups., Proportion of participants who have a decrease of ≥4 points in QMG score at Month 4 compared to Baseline in the active versus placebo group., Decrease from baseline in MG-ADL score at Month 2 and Month 3 follow-up in the active versus placebo group., Decrease from baseline in MGC score at Month 2 and Month 3 follow-up in the active versus placebo group., Decrease from Baseline at Month 2, Month 3 and Month 4 in QMG score in active versus placebo groups.

—

Primary

Measure	Time frame
Proportion of participants who have a decrease of ≥3 points in MG-ADL score at Month 4 compared to Baseline in the active versus placebo group.	—

Countries

Italy, Poland, Spain

Outcome results

None listed