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A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC in Adults With Ocular Myasthenia Gravis

Study acronym: ADAPT oculus
StatusActive, Not Recruiting
PhasePhase 3
Sponsorargenx
Started2024-09-18
View on ClinicalTrials.gov ↗

Amendment history

2026-07-01
Study Status v13
Primary completion dateestimated 2026-01→confirmed 2026-01-12
2025-12-10
Recruiting→Active, Not Recruiting Study Status, Study Design, Outcome Measures, Contacts/Locations v12
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2025-12→2026-01
Enrollment targetestimated 124→confirmed 141
Study sites103→102
Secondary endpointsdetails revised at 8 of 13 entries
2025-11-03
Study Status, Oversight, Contacts/Locations v11
Study sites101→103
2025-09-30
Study Status, Contacts/Locations v10
Study sites78→101
2025-08-14
Study Status, Contacts/Locations v9
Study sites73→78
Show 8 earlier versions
2025-07-17
Study Status, Contacts/Locations v8
Study sites59→73
2025-06-12
Study Status, Contacts/Locations v7
Study sites49→59
2025-05-05
Study Identification, Study Status, Contacts/Locations v6
Study sites20→49
Study titlerevised
A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC in Adults withWith Ocular Myasthenia Gravis
2025-03-25
Study Status, Contacts/Locations v5
Study sites9→20
2025-02-10
Study Status, Contacts/Locations v4
Study sites4→9
2025-01-07
Study Status, Contacts/Locations v3
Study sites3→4
2024-11-15
Study Status, Contacts/Locations v2
Study sites1→3
2024-10-08
Not Yet Recruiting→Recruiting Study Identification, Study Status, Oversight, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-09-15→confirmed 2024-09-18
Study sites0→1
Study titlerevised
A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC in Adults Withwith Ocular Myasthenia Gravis
2024-08-14
Original filing
Argenx
56 trials monitored
See 2 trials at risk
Myasthenia Gravis
187 trials monitored
See 7 trials at risk
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.
Trial Details
NCT Number NCT06558279
Lead Sponsor argenx
Conditions Myasthenia Gravis, Ocular
Enrollment 141 participants
Start Date 2024-09-18
Primary Completion 2026-01-12 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-07-02