A Randomized, Double-Blinded, Placebo-Controlled, Phase 3, Parallel-Group Design Study Evaluating the Efficacy and Safety of Efgartigimod PH20 SC Administered by Prefilled Syringe in Adult Participants With Ocular Myasthenia Gravis

Conditions

Ocular Myasthenia Gravis

Brief summary

MGII (PRO) ocular score change from baseline to day 29 in part A

Detailed description

• MGII (PRO+PE) ocular score change from baseline to day 29 in part A, • MG-ADL ocular domain score change from baseline to day 29 in part A, • MGII total score change from baseline to day 29 in part A, • MGII (PE) ocular score change from baseline to day 29 in part A, • MG-ADL total score change from baseline to day 29 in part A, • MGII ocular scores (PRO, PRO+PE, and PE), generalized score, and total score; actual values and changes from baseline in part A and part A+B, • Incidence and severity of AEs and SAEs in part A and part A+B, • Clinically relevant changes in laboratory parameters, vital signs, and ECGs in part A and part A+B, • MG-QoL15r total score actual values and changes from baseline in part A and part A+B, • NEI VFQ-25 score actual values and changes from baseline in part A and part A+B, • Actual values and percent changes from baseline in total IgG levels over time in part A and part A+B, Actual values and percent change from baseline in AChR-Ab levels in AChR-Ab seropositive participants over time in part A and part A+B, • Incidence and prevalence of Anti-Drug Antibodies and Neutralizing Antibodies against efgartigimod in part A and part A+B, • Incidence and prevalence of antibodies and Neutralizing Antibodies against rHuPH20 in part A and part A+B

Related papers

No related papers found yet.

Interventions

DRUGVyvgart 1 000 mg solution for injection in pre-filled syringe

DRUGPlacebo PH20 SC

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
MGII (PRO) ocular score change from baseline to day 29 in part A	—

Secondary

Measure	Time frame
• MGII (PRO+PE) ocular score change from baseline to day 29 in part A, • MG-ADL ocular domain score change from baseline to day 29 in part A, • MGII total score change from baseline to day 29 in part A, • MGII (PE) ocular score change from baseline to day 29 in part A, • MG-ADL total score change from baseline to day 29 in part A, • MGII ocular scores (PRO, PRO+PE, and PE), generalized score, and total score; actual values and changes from baseline in part A and part A+B, • Incidence and severity of AEs and SAEs in part A and part A+B, • Clinically relevant changes in laboratory parameters, vital signs, and ECGs in part A and part A+B, • MG-QoL15r total score actual values and changes from baseline in part A and part A+B, • NEI VFQ-25 score actual values and changes from baseline in part A and part A+B, • Actual values and percent changes from baseline in total IgG levels over time in part A and part A+B, Actual values and percent change from baseline in AChR-Ab levels in AChR-Ab serop	—

Measure

Time frame

• MGII (PRO+PE) ocular score change from baseline to day 29 in part A, • MG-ADL ocular domain score change from baseline to day 29 in part A, • MGII total score change from baseline to day 29 in part A, • MGII (PE) ocular score change from baseline to day 29 in part A, • MG-ADL total score change from baseline to day 29 in part A, • MGII ocular scores (PRO, PRO+PE, and PE), generalized score, and total score; actual values and changes from baseline in part A and part A+B, • Incidence and severity of AEs and SAEs in part A and part A+B, • Clinically relevant changes in laboratory parameters, vital signs, and ECGs in part A and part A+B, • MG-QoL15r total score actual values and changes from baseline in part A and part A+B, • NEI VFQ-25 score actual values and changes from baseline in part A and part A+B, • Actual values and percent changes from baseline in total IgG levels over time in part A and part A+B, Actual values and percent change from baseline in AChR-Ab levels in AChR-Ab serop

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Countries

Austria, Belgium, Cyprus, Czechia, Denmark, Finland, France, Germany, Greece, Italy, Netherlands, Poland, Portugal, Spain, Sweden

Outcome results

None listed