drugset / Trial / NCT01963611
Efficacy, Safety, and Tolerability of Plovamer Acetate (Pathway 1)
RandomizedParallel-groupSingle-blindTreatment
Summary
This is a Phase 2, randomized, rater-blinded, 5-arm, parallel-group trial that will test 4 doses of plovamer acetate against the active comparator Copaxone in subjects with Relapsing Remitting Multiple Sclerosis (RRMS). The trial will be conducted on an outpatient basis for minimum treatment duration of 40 weeks.
Timeline
- Start
- 2013-10
- Primary completion
- 2015-03
- Completion
- 2015-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Glatiramer Acetate | Small molecule | 20 mg | Subcutaneous |
| Subject | Plovamer acetate | Small molecule | 0.5 mg | Subcutaneous |
| Subject | Plovamer acetate | Small molecule | 3 mg | Subcutaneous |
| Subject | Plovamer acetate | Small molecule | 10 mg | Subcutaneous |
| Subject | Plovamer acetate | Small molecule | 20 mg | Subcutaneous |