Clinical trial · Interventional
A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC in Adults With Ocular Myasthenia Gravis
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myasthenia Gravis, Ocular | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Efgartigimod PH20 SC | Combination Product | — | UNRESOLVED |
| Placebo PH20 SC | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Efgartigimod PH20 SC in part A+B
- description
- Participants receiving efgartigimod PH20 SC during part A and part B
- interventionNames
- Combination Product: Efgartigimod PH20 SC
- type
- EXPERIMENTAL
- label
- Placebo PH20 SC in Part A + Efgartigimod PH20 SC in Part B
- description
- Participants receiving placebo PH20 SC in Part A and Efgartigimod PH20 SC in Part B
- interventionNames
- Combination Product: Efgartigimod PH20 SC
- Other: Placebo PH20 SC
Primary outcomes (1)
- measure
- MGII (PRO) ocular score change from baseline to day 29 in part A
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Is at least 18 years of age and the local legal age of consent for clinical studies * Has been diagnosed with myasthenia gravis and supported by seropositivity for AChR-Ab; or abnormal neuromuscular transmission demonstrated by abnormal neurophysiology testing and history on positive edrophonium chloride testing or demonstrated improvement on MG therapy" * Is MGFA Class I (any ocular muscle weakness) * Has a screening and baseline MGII (PRO) ocular score of at least 6 with at least 2 ocular items with a score of at least 2 Exclusion Criteria: * Other diseases that lead to eyelid drooping, peripheral muscle weakness, or diplopia * Known autoimmune disease or any medical condition other than indication under study that would interfere with an accurate assessment of clinical symptoms of ocular myasthenia gravis or puts the participant at undue risk
References
Publications (0)
Data not yet available