Efgartigimod for the Treatment of Acute Optic Neuritis

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Anastasia Vishnevetsky, MD, MPH
Study ID
NCT06453694
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Optic Neuritis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Efgartigimod Alfa — DRUG
    2,016 mg will be administered subcutaneously by a healthcare provider on Day 0 and Day 3 of the trial. Rescue therapy with therapeutic plasma exchange will be given to any participant based on the results of Day 7 evaluation.
  • Placebo — DRUG
    Subcutaneous injection of placebo will be administered by a healthcare provider on Day 0 and Day 3 of the trial. Rescue therapy with therapeutic plasma exchange will be given to any participant based on the results of Day 7 evaluation.

Study Details

The goal of this pilot clinical trial is to test efgartigimod alfa against placebo in adults with first-time optic neuritis (optic nerve inflammation). The main questions it aims to answer are: * Is it feasible to use efgartigimod alfa for optic neuritis? * Is it feasible to run a larger trial testing efgartigimod alfa in optic neuritis? * Does efgartigimod alfa work better than placebo in improving how quickly and how much vision returns? Participants will: * have their vision and blood tested * be asked questions about their vision * will receive standard of care treatment with steroids regardless of whether they are receiving efgartigimod alfa or not * will have periodic visits over 6 months

Key Dates

Start date
Aug 12, 2025
Status verified
Nov 2025
Primary completion
Dec 31, 2026
Completion
Jul 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Efgartigmod alfa
    10 patients will receive efgartigimod alfa All participants will receive standard of care high dose corticosteroids for 3 days with a prednisone taper over 3 weeks.
  • Placebo Comparator: Placebo
    10 patients will receive placebo. All participants will receive standard of care high dose corticosteroids for 3 days with a prednisone taper over 3 weeks.

Primary Outcome Measure

Recruitment Rate [ Time Frame: 2 years ]

Locations (2)

FacilityCityStateZIPSite coordinators
Massachusetts Eye and Ear InfirmaryBostonMassachusetts02114
Marc Bouffard, MD
[email protected]
(617) 523-7900
Marc Bouffard, MD (SUB_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114
Anastasia Vishnevetsky, MD, MPH
[email protected]
617-726-8639
Anastasia Vishnevetsky, MD, MPH (PRINCIPAL_INVESTIGATOR)
Denis T Balaban, MD (SUB_INVESTIGATOR)
Michael Levy, MD, PhD (SUB_INVESTIGATOR)
Marc Bouffard, MD (SUB_INVESTIGATOR)

Find similar trials in Boston, MA

By research site
Massachusetts Eye and Ear Infirmary· Boston, MAMassachusetts General Hospital· Boston, MA

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