Phase 2 Study of Efgartigimod Alfa in Humans
This Phase 2 interventional study planned to enroll 20 human participants to assess the effects of Efgartigimod Alfa compared to a placebo. Endpoints included recruitment rates, adherence rates, and changes in visual acuity over time. However, no results have been posted from the trial yet.
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- Source
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- Human efficacy
- Not established from this source
- Mechanism
- Not reported
- Evidence strength
- No results yet
- Outcome
- Not reported
Why it matters
Understanding the effects of Efgartigimod Alfa on visual acuity is important to explore its potential benefits in the relevant conditions. This study's design aims to provide rigorous data on the drug's effectiveness and safety.
What this does not prove
The study has not yet reported any results, rendering its primary endpoints and findings unknown. Planned enrollment does not constitute published findings.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Interventional
- Participants / samples
- 20 · planned enrolment
- Randomised
- Yes
- Controlled
- Yes
- Primary endpoint met
- Not reported
- Relevant MS type
- Not reported
- Publication date
- Not reported
- Evidence reviewed
- Trial registry record
- Regulatory approval
- Not reported
- Research areas
- Other
- Biological target
- Not reported
- Pathway
- Not reported
- Population
- Not reported
- Size of effect
- Not reported
- Secondary endpoints
- Not reported
- MRI endpoints
- Not reported
- Biomarkers
- Not reported
- Safety
- Not reported
Original sources
- Trial registrationEfgartigimod for the Treatment of Acute Optic Neuritis ↗
Supporting passages (15)
study phasePhase: Phase 2
study designStudy type: Interventional
subjectsParticipants: people; ages from 18 Years; sex All
speciesParticipants: people; ages from 18 Years; sex All
sample sizeEnrollment: 20 participants (estimated)
randomizedAllocation: Randomized
controlledArm types: Active comparator; Placebo comparator
research categories"name": "Efgartigimod Alfa",
findingsTrial registry record. Publication date: unknown. No results are posted. Planned enrolment and endpoints are not findings.
limitationsTrial registry record. Publication date: unknown. No results are posted. Planned enrolment and endpoints are not findings.
peer reviewedTrial registry record.
primary endpointPrimary endpoints: Recruitment Rate; Study Adherence Rate; Change in high contrast visual acuity for effect size and standard deviation estimation; Change in low contrast visual acuity for effect size and standard deviation estimation
interventionInterventions: Efgartigimod Alfa; Placebo
follow upFollow-up: 2 years; 1 month; 30 days; 3 months; 6 months; Day 7
sample size basisEnrollment: 20 participants (estimated)
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