Safety Study of an Immunomodulating Microparticle to Treat Progressive Multiple Sclerosis
|ClinicalTrials.gov Identifier: NCT01191996|
Recruitment Status : Completed
First Posted : August 31, 2010
Last Update Posted : December 7, 2012
|Condition or disease||Intervention/treatment||Phase|
|Secondary Progressive Multiple Sclerosis Primary Progressive Multiple Sclerosis||Biological: MIS416||Phase 1 Phase 2|
This is a single center, open-label, non-randomized, dose-escalation study, to be conducted in two phases:
- a dose-escalation (DE) phase, to evaluate the safety, tolerability, MTD, and PD of MIS416 administered IV once weekly for 4 doses; and
- a dose-confirmation (DC) phase, which will be a cohort expansion at or below the MTD (i.e., the RTD) of MIS416, dosed once weekly for up to 12 doses.
Subjects will be treated with a weekly IV dose of MIS416 in 28-day cycles: 1 cycle in the DE phase, and up to 3 cycles in the DC phase. Subjects will be evaluated and dosed weekly each cycle in each phase. Subjects will return for a follow-up visit 7 days after completion of the last dose of study drug.
The primary objectives of this study are:
- To determine the safety and tolerability, dose-limiting toxicities (DLTs), maximum tolerated dose (MTD), and recommended therapeutic dose (RTD) of intravenously (IV) administered MIS416 weekly in patients with chronic progressive multiple sclerosis (CPMS); and
- To assess the pharmacodynamic (PD) effects of MIS416, including effects on serum cytokine levels and peripheral blood mononuclear cell (PBMC) composition, cytokine/chemokine expression and function.
The secondary objectives of this study are:
- To document any changes in MS clinical status occurring during the 12-week MIS416 dosing period in the dose-confirmation phase, as determined by the Multiple Sclerosis Functional Composite (MSFC), Fatigue Severity Scale (FSS), Short Form Health Survey (SF-36), and Expanded Disability Status Scale (EDSS); the frequency of clinical relapses; and signs of clinical activity on serial cranial MRI scans; and
- To evaluate, in exploratory fashion, any correlations between clinical, radiological and PD outcomes.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2, Open-label, Dose-escalation Study Evaluating the Safety, Tolerability, and Pharmacodynamics of Intravenously Administered MIS416 in Patients With Chronic Progressive Multiple Sclerosis|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||November 2012|
MIS416, immunomodulating microparticle, given intravenously weekly
MIS416 intravenously every week
- Safety profile, including maximum tolerated dose [ Time Frame: 1 month in DE phase, 3 months in DC phase ]Dose-limiting toxicities, adverse events, safety MRI assessments
- Pharmacodynamic assessments [ Time Frame: 1 month in DE phase, 3 months in DC phase ]Serum and cellular immunological assays
- MRI assessments [ Time Frame: 1 month in DE phase, 3 months in DC phase ]Safety MRIs
- Clinical status [ Time Frame: 3 months in DC phase ]Neurological examination, Expanded Disability Status Scale (EDSS), Multiple Sclerosis Functional Composite (MSFC), Fatigue Severity Scale (FSS), Multiple Sclerosis Quality of Life (MSQLI).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01191996
|Primorus Clinical Trials, 40 Stewart Street|
|Christchurch, Canterbury, New Zealand, 8011|
|Principal Investigator:||Alison Luckey||Primorus Clinical Trials|
|Principal Investigator:||Tim Anderson||Department of Medicine, University of Otago|