IMCY-0141 Safety and Efficacy in Multiple Sclerosis - ISEMIS Study

"The investigational medicinal product (IMP) consists in a small synthetic peptide (23 amino acids - IMCY-0141) combining a known human epitope of MOG flanked with a thioredox motif, presented in the form of a freeze-dried sterile powder and diluent for subcutaneous (SC) administration. The diluent includes the adjuvant aluminium hydroxide (alum) at a concentration of 900 μg/mL. Treatment will be injected within 4h of resuspension of the powder with the diluent.~Treatment will consist of 6 immunizations (separated by 14 days) of the IMP by SC injection in the upper arm, in the region of the triceps (lateral part of the arm, midway between the elbow and the shoulder). Half of the dose to be administered will be injected concomitantly in both arms."

"The placebo will be administered by subcutaneous route, once every two weeks for 6 times. Placebo will be administered to patients randomized in the placebo group during Phase II only."

"Dimethyl Fumarate (DMF) will be given orally, according to its SmPC for the whole duration of the study.~Dimethyl Fumarate (DMF) will be administered to patients randomized in the active control group during Phase II only."