Safety of IxaZOmib targeting plasma cells in MS (SIZOMUS)
Research type
Research Study
Full title
Safety of ixazomib targeting plasma cells in multiple sclerosis: A phase 1b randomised, double-blind, placebo-controlled trial.
IRAS ID
251703
Contact name
Sharmilee Gnanapavan
Contact email
Sponsor organisation
Barts Health NHS Foundation Trust
Eudract number
2018-003686-34
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Multiple Sclerosis (MS) is a chronic and progressive autoimmune disorder that occurs when the immune system attacks and destroys the layer surrounding the nerves (myelin sheath) in the brain and spinal cord. This breaks down communication between nerve cells and results in motor, sensory and cognitive problems. Patients at the early disease stages may have access to disease modifying therapies(DMTs) which aim to slow down disease progression, but there is currently no cure. Furthermore, there are no DMTs available to patients at later disease stages. This double-blind, randomised, placebo-controlled trial will investigate the effect of ixazomib, an inhibitor of the 20S proteasome, on MS. The primary objective of the study is to assess the safety of ixazomib in subjects with relapsing remitting MS (RRMS) and primary and secondary progressive MS (PPMS and SPMS). The co-primary endpoint is the efficacy of ixazomib in eliminating plasma cell oligoclonal bands(OCB) from the cerebrospinal fluid (CSF).
Summary of the main inclusion criteria:
1. Male and female patients 18 to 65 years old at screening
2. Diagnosis of MS
3. Patients with early disease (RRMS) must be on stable DMTs
4. OCB positive CSF
5. Able and willing to give written informed consent and comply with protocol requirements
6. Must comply with pregnancy prevention measures (women and men).Participants will be recruited from the MS clinic at The Royal London Hospital, (some may be referred from elsewhere) and will be enrolled in the study for up to 27 months (a 2-month screening, 24-month treatment, and 1-month follow-up period). Study visits will take place once every month (28 days) but may be extended to two-monthly after the first 6 months depending on tolerability and adverse events (AEs).Participants will undergo safety assessments (examination, vital signs, blood and urine tests) at each visit. Efficacy endpoints assessments will take place at 12 and 24 months.
REC name
London - Dulwich Research Ethics Committee
REC reference
19/LO/0165
Date of REC Opinion
17 Apr 2019
REC opinion
Further Information Favourable Opinion