Treatment of Inflammatory Myelitis and Optic Neuritis With Early vs Rescue Plasma Exchange (TIMELY-PLEX)

Recruiting now · Phase 3

Conditions studied: Optic Neuritis, Myelitis, Myelitis, Transverse

In brief

The purpose of this research is to evaluate if early vs rescue Therapeutic Plasma Exchange (PLEX) treatment algorithm leads to better visual outcomes in severe Optic Neuritis and leads to better neurological disability outcomes in severe Transverse Myelitis.

Key facts

Study ID

NCT07100990

Run by

Mayo Clinic

People needed

382

Starts

2025-07-11

Expected to finish

2031-04-30

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥18 years of age
• MRI orbits demonstrating evidence of new T2 hyperintensity and/or post-gadolinium contrast enhancement of the optic nerve(s) and meeting the clinical criteria for Optic Neuritis
• Visual acuity 20/200 or worse
• Within 8 days of onset of visual symptoms
• Able to initiate PLEX within 72h of the first dose of HDCS (if randomized to the "Early PLEX" treatment arm)
• Able to sign and date informed consent form
• Willingness to comply with all study procedures and availability for the duration of the study

You may not qualify if…

• Evidence of prior episode of optic neuritis in the affected eye (by history or ophthalmological evaluation)
• Ophthalmological comorbidity that would significantly affect best corrected visual acuity or visual fields
• Pregnancy
• Presence of any contraindication to receiving HDCS or PLEX, including, but not limited to, hemodynamic instability, significant bleeding/coagulopathy, or sepsis.
• Any medical condition that, in the opinion of the investigator, may interfere with the patient's participation in the trial, pose any added risk for the patient, or confound the assessment of the patient (including but not limited to concurrent neurological disease and/or medical comorbidity)
• Treatment with any investigational agent within 6 months of baseline or five half-lives of the investigational agent (whichever is longer)
• Ongoing/prior treatment with immune-modulating/immunosuppressive therapy including:
• Mycophenolate mofetil, azathioprine, methotrexate, fingolimod, siponimod, ponesimod, ozanimod, tocilizumab, satralizumab, eculizumab or ravulizumab within 3 months of randomization
• Anti-CD20 (rituximab, ocrelizumab, ofatumumab, ublituximab) or anti-CD19 (inebilizumab) therapy within 6 months of randomization
• Intravenous or subcutaneous immune globulin within 3 months of randomization
• Plasma exchange within 3 months of randomization
• Interferon-beta, glatiramer acetate, fumarates (dimethyl fumarate, monomethyl fumarate, diroximel fumarate) within 1 month of randomization
• Teriflunomide use within prior 24 months
• Systemic corticosteroid therapy (intravenous or oral; excluding inhaled or topical corticosteroids) within 1 month of randomization
• Any previous treatment with alemtuzumab, cladribine, mitoxantrone or cyclophosphamide
• Previous treatment with any immune-modulating or immunosuppressive therapy not mentioned above within 6 months of randomization or five-half-lives (whichever is longer)
• Transverse Myelitis Sub-Trial:
• Inclusion criteria:
• ≥18 years of age
• Diagnosis of Transverse Myelitis (defined based on modified criteria adapted from the 2002 Transverse Myelitis Consortium Working Group; ALL are required)
• Development of sensory, motor and/or autonomic symptomatology attributable to spinal cord dysfunction
• Onset of symptoms to nadir >12 hours
• Exclusion of extra-axial compressive etiology by neuroimaging
• Demonstration of inflammation within the spinal cord by presence of intramedullary T2 lesion (post-gadolinium enhancing OR non-enhancing) on MRI
• Expanded Disability Status Scale [EDSS] ≥3.0 (excluding visual and cerebral functional systems)

Where it is running

• University of Washington — Seattle, Washington, United States (enrolling)
• UT Southwestern Medical Center — Dallas, Texas, United States (enrolling)
• University of Utah — Salt Lake City, Utah, United States (enrolling)
• University of Virginia — Charlottesville, Virginia, United States (enrolling)
• Mayo Clinic Arizona — Scottsdale, Arizona, United States (enrolling)
• University of California, Davis — Sacramento, California, United States (enrolling)
• University of Colorado - Anschutz Medical — Aurora, Colorado, United States (enrolling)
• Yale University School of Medicine — North Haven, Connecticut, United States (enrolling)
• Mayo Clinic Florida — Jacksonville, Florida, United States (enrolling)
• University of Miami — Miami, Florida, United States (enrolling)
• University of Illinois Chicago — Chicago, Illinois, United States (enrolling)
• Northwestern University — Evanston, Illinois, United States (enrolling)
• Indiana University — Indianapolis, Indiana, United States (enrolling)
• University of Maryland, Baltimore — Baltimore, Maryland, United States (enrolling)
• Johns Hopkins University — Baltimore, Maryland, United States (enrolling)
• Medstar Health Research Institute — Columbia, Maryland, United States (enrolling)
• Harvard University Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Boston Medical Center — Boston, Massachusetts, United States (enrolling)
• Regents of the University of Michigan — Ann Arbor, Michigan, United States (enrolling)
• Mayo Clinic in Rochester — Rochester, Minnesota, United States (enrolling)
• University of Mississippi Medical Center — Jackson, Mississippi, United States (enrolling)
• Icahn School of Medicine at Mount Sinai — New York, New York, United States (enrolling)
• Columbia University — New York, New York, United States (enrolling)
• Weill Cornell Medical College — New York, New York, United States (enrolling)
• Duke University Health System — Durham, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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