Status and phase
Conditions
Treatments
About
Phase 1 study to assess the safety and biological activity of ATX-MS-1467 in patients with relapsing forms of multiple sclerosis. This will be an open label upward dose titration involving injections on 9 occasions, each two weeks apart. After dosing is complete there will be a 22 week follow up period. Blood samples will be drawn throughout the study to monitor safety and the body's response to the injections and MRI scans will be performed on several occasions to follow the course of the multiple sclerosis during the trial.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Patients who have definite relapsing multiple sclerosis disease as defined by the McDonald criteria (McDonald et al., 2001 and 2005) and as assessed by a neurologist.
HLA DRB1*15 positive.
High baseline levels of T-cell proliferation in response to myelin basic protein, defined as >1000 cpm with a >3 stimulation index compared to background.
Disease duration equal to or less than 10 years (from the first clinical event).
At least one documented relapse in the previous 12 months or two relapses within the previous 24 months prior to screening.
Must be in a clinically stable or improving neurological state during the 28 days preceding Screening.
EDSS score < 5.5.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
43 participants in 2 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal