Overview

Ocrelizumab or Alemtuzumab Compared With Autologous Hematopoietic Stem Cell Transplantation in Multiple Sclerosis - a Phase-2 Randomised Controlled Trial

Status:
Recruiting

Trial end date:
2027-08-01

Target enrollment:

Participant gender:

Summary

A multicentre controlled phase II trial to compare the efficacy and safety of ocrelizumab or alemtuzumab and autologous Hematopoietic Stem Cell Transplantation (aHSCT). Active relapsing-remitting MS-Patients will be included and randomised to ocrelizumab or alemtuzumab versus aHSCT. Primary endpoint will be the time to treatment failure as assessed by failure of NEDA (no evidence of disease activity) as represented by: no expanded disability status scale (EDSS) progression, no relapse, no new T2 lesion and no Gd-enhancing lesion. This trial offers the opportunity to gain further information about efficacy and safety of all treatments and will give new insights into the immunology of highly active RRMS.

Phase:

Phase 2

Details

Lead Sponsor:

Universitätsklinikum Hamburg-Eppendorf

Collaborators:

Clinical Trial Center North (CTC North GmbH & Co. KG)
Neovii Biotech

Treatments:

Alemtuzumab
Ocrelizumab