Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02228213 | Safety and Efficacy Study of MIS416 to Treat Secondary Progressive Multiple Sclerosis | PHASE2 | COMPLETED | 93 | — | — | Oct 1, 2014 | Jun 1, 2017 | Jul 14, 2017 | 7 | Australia, New Zealand |
| NCT01191996 | Safety Study of an Immunomodulating Microparticle to Treat Progressive Multiple Sclerosis | PHASE1 | COMPLETED | 34 | — | — | Aug 1, 2010 | Nov 1, 2012 | Dec 7, 2012 | 1 | New Zealand |
Neuromuscular function will be assessed using the following test: * MS Function Composite (MSFC), comprising the; timed 25 Foot Walk, 9 Hole Peg Test (9HPT), and Paced Auditory Serial Addition Test (PASAT); * Jebsen Hand Function Test (JHFT); * Grip, tip and key pinch strength; * Symbol digit modalities test (SDMT); * Sloan low-contrast letter visual acuity (SLCVA); * 6-minute walk test (6MWT);
Safety assessments will be conducted at each study visit and include; characterization of the type, incidence, severity, timing, seriousness, and relationship to treatment of adverse events (AEs); effects on vital signs and clinical laboratory parameters; changes on electrocardiograms (ECGs); and at 3 months and 12 months - the number of gadolinium-enhancing lesions on cranial MRI assessments.
Dose-limiting toxicities, adverse events, safety MRI assessments
| Arm | Type | Description |
|---|---|---|
| Treatment | EXPERIMENTAL | 500 mcg MIS416 500 at 0.2 mg/mL administered i.v. once weekly for 52 weeks |
| Saline | PLACEBO_COMPARATOR | Saline administered i.v. once weekly for 52 weeks |
| MIS416 | EXPERIMENTAL | MIS416, immunomodulating microparticle, given intravenously weekly |
| Name | Type | Description |
|---|---|---|
| MIS416 | BIOLOGICAL | Intravenous administration weekly for 52 weeks |
| Saline | DRUG | Intravenous administration weekly for 52 weeks |
Inclusion Criteria: 1. A historical or current cranial MRI scan demonstrating T2-hyperintense lesions consistent with MS. 2. Has SPMS as determined by the 2010 Update to the McDonald Criteria 3. An Expanded Disability Status Scale (EDSS) of 3.0 to 6.5 at Screening. 4. Has SPMS which, in the judgmen...