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

PHASE3RecruitingINTERVENTIONAL
Enrollment

382

Participants

Timeline

Start Date

July 11, 2025

Primary Completion Date

April 1, 2029

Study Completion Date

April 30, 2031

Conditions
Optic NeuritisMyelitisMyelitis, Transverse
Interventions
DRUG

High-dose corticosteroids (HDCS)

"Subjects will receive initial treatment with high-dose corticosteroids (HDCS) in the form of methylprednisolone (1,000mg daily) administered intravenously for 5 days or a bioequivalent dose of oral corticosteroids (e.g., 1,250mg prednisone daily or 176mg dexamethasone daily).~Subjects will be escalated to PLEX if there is an insufficient response to HDCS (decision point at 14±2 days for the ON sub-trial and 7±2 days for the TM sub-trial) PLEX will be performed as 5 sessions over 5-10 days, with 1-1.5 plasma volumes exchanged per session."

DRUG

High-dose corticosteroids (HDCS) and PLEX

"Subjects will receive treatment with high-dose corticosteroids (HDCS) and PLEX initiated concurrently.~HDCS will be administered in the form of methylprednisolone (1,000mg daily) administered intravenously for 5 days or a bioequivalent dose of oral corticosteroids (e.g., 1,250mg prednisone daily or 176mg dexamethasone daily).~PLEX will be performed as 5 sessions over 5-10 days, with 1-1.5 plasma volumes exchanged per session."

Trial Locations (2)

21218

RECRUITING

Johns Hopkins University, Baltimore

55905

RECRUITING

Mayo Clinic in Rochester, Rochester

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Patient-Centered Outcomes Research Institute

OTHER

lead

Mayo Clinic

OTHER

NCT07100990 - Treatment of Inflammatory Myelitis and Optic Neuritis With Early vs Rescue Plasma Exchange (TIMELY-PLEX) | Biotech Hunter | Biotech Hunter