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 (ADAPT oculus)

NCT06558279 Phase 3 ACTIVE_NOT_RECRUITING

The purpose of this study is to evaluate the efficacy and safety of efgartigimod PH20 SC given by a pre-filled syringe in adult patients with ocular myasthenia gravis. The study consists of a part A (approximately 7 weeks) and a part B (up to 2 years). In part A, half of the participants will receive efgartigimod PH20 SC and the other half will receive placebo. In part B, all participants will receive efgartigimod PH20 SC. The participants will be in the study for about up to 2 years and 12 weeks.

Details

Lead sponsor	argenx
Phase	Phase 3
Status	ACTIVE_NOT_RECRUITING
Enrolment	141
Start date	2024-09-18
Completion	2027-12

Conditions

• Myasthenia Gravis, Ocular

Interventions

• Efgartigimod PH20 SC
• Placebo PH20 SC

Primary outcomes

• MGII (PRO) ocular score change from baseline to day 29 in part A — Up to 29 days
  The Myasthenia Gravis Impairment Index (MGII) is a scoring tool measuring disease severity. It consists of 22 patient-reported outcomes (PRO) and 6 physical examinations (PE). The Ocular PRO score varies between 0 and 18. The higher the score, the more severe the disease.

Countries

United States, Australia, Austria, Belgium, Canada, China, Cyprus, Czechia, Denmark, Finland, France, Georgia, Germany, Greece, Italy, Japan, Netherlands, Poland, Portugal, Serbia, South Korea, Spain, Sweden, United Arab Emirates, United Kingdom