Study of IMCY-0141 in Recent Onset of Multiple Sclerosis
Status:
Recruiting
Trial end date:
2025-12-31
Target enrollment:
Participant gender:
Summary
The IMCY-MS-001 study is a study to test a new experimental drug, IMCY-0141, for the
treatment of Relapsing-Remitting Multiple Sclerosis (RR-MS).
The pathophysiology of MS with known myelin autoantigens and T cell epitopes makes this
disease a particularly attractive indication for development of an immunotherapeutic based on
the Imcyse technology.
Based on the unique mechanism of action of the drug, IMCY-0141 administered as early as
possible after confirmation of the diagnosis may potentially switch-off the autoimmune
process and limit the corresponding myelin destruction. Newly (recently) diagnosed patients
will be targeted to tackle the disease at its onset.
Before launching any efficacy studies, safety of IMCY-0141 in MS patients must be evaluated
with a phase I, open-label, dose escalation clinical trial to evaluate the safety of three
IMCY-0141 doses followed by a phase II, double-blind, randomized study with an adaptive
design to determine if any IMCY-0141 dose(s) offer superior efficacy relative to placebo and
to assess immune responses and biomarker data as potential early predictors of efficacy of
IMCY-0141 in adults presenting with RR-MS.