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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
43
Disease specific immune modulating treatment for multiple sclerosis
Municipal Healthcare Institution "City Clinical Hospital #3", Department of neurology
Safety and Tolerability
Occurrence of treatment emergent Adverse Events (AE), Serious Adverse Events, and laboratory abnormalities up to week 48 compared to baseline.
Time frame: 48 weeks
The Effect of ATX-MS-1467 on Brain Magnetic Resonance Imaging (MRI).
Number of new or persisting Gadolinium-enhancing lesions at week 16 and 20 when compared to baseline.
Time frame: 16 and 20 weeks
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Chelyabinsk, Russia
State Medical Institution "Republican Clinical Hospital of rehabilitation treatment of Ministry of Healthcare of Tatarstan Republic", Republican clinicodiagnostic center of demyelinating diseases of Ministry of Healthcare of Tatarstan Republic
Kazan', Russia
State Educational Institution of Higher Professional Education "1st Moscow State Medical University n.a. I.M. Sechenov of Ministry of Healthcare and Social Development of the Russian Federation, Department of new drugs research
Moscow, Russia
State Healthcare Institution 'Rostov Regional Clinical Hospital' Center of Neurology
Rostov-on-Don, Russia
LLC "International Clinic MEDEM", Department of functional diagnostics
Saint Petersburg, Russia
St. Petersburg State Healthcare Institution "City multifield hospital #2", Department of neurology #2
Saint Petersburg, Russia
State Educational Institution of Higher Professional Education "St. Petersburg State Medical University n.a. I.V. Pavlov of Roszdrav", Department of neurology with clinic
Saint Petersburg, Russia
Institution of the Russian Academy of Science "Institute of Human Brain of RAS", Neuroimmunology Laboratory
Saint Petersburg, Russia
State Healthcare Institution "Samara Regional Clinical Hospital n.a. M.I. Kalinin", Department of neurosurgery
Samara, Russia
State Educational Institution of Higher Professional Education Saratov State Medical University
Saratov, Russia
...and 6 more locations