Relapsing Remitting Multiple Sclerosis
Conditions
Keywords
RRMS
Brief summary
The purpose of this study is to evaluate the safety and efficacy of NU100 in patients with relapsing remitting multiple sclerosis (RRMS) as compared to placebo and an active comparator. The primary clinical objective selected for this Phase 3 study, the cumulative number of new combined unique active lesions (CALs; defined as new gadolinium T1-weighted lesions and non-enhancing new and newly enlarging T2-weighted lesions) on magnetic resonance imaging (MRI) scans over the course of 4 and 12 months of treatment to demonstrate the superiority of NU100 to placebo and the non-inferiority of NU100 to Betaferon®, respectively.
Interventions
BIOLOGICALNU100
0.25 mg SQ, every other day for 12 months
BIOLOGICALPlacebo
1 mL SQ, every other day for 4 months
BIOLOGICALrhIFN beta-1b
0.25 mg SQ, every other day for 12 months
Sponsors
Nuron Biotech Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
Patients will be eligible to participate in the study if all of the following criteria are met at both screening (V-1) and baseline (V0): 1. Female or male patients, aged between 18 and 60 years, inclusive 2. Signed and dated statement of informed consent 3. Diagnosis of RRMS according to McDonald's Criteria - revision 2010 (Polman et al., 2011) 4. Interferon (IFN) beta-1b naïve 5. Expanded Disability Status Scale (EDSS) score of \< 5.5 6. At least 1 documented relapse in the past year (defined as the appearance of a new clinical sign/symptom \[one that had been stable for at least 30 days\] that persisted for a minimum of 24 hours in the absence of fever) ---or--- a subclinical sign/symptom (defined as a Gd-enhancing lesion or a new T2 lesion demonstrated on MRI examination on a prior MRI that has been completed within 1 year of the screening MRI). The Screening (V-1) MRI should not be used for this determination. 7. No relapse in the 4 weeks prior to the screening visit (V-1). 8. Must be in a clinically stable or improving neurological state 4 weeks preceding the screening visit (V-1).
Exclusion criteria
Patients meeting any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| New CALs after 4 months of treatment based on the MRI outcomes obtained at 4 and 12 months | 2 to 12 months | The primary clinical objective selected for this Phase 3 study, the cumulative number of new combined unique active lesions (CALs; defined as new gadolinium T1-weighted lesions and non-enhancing new and newly enlarging T2-weighted lesions) on magnetic resonance imaging (MRI) scans over the course of 4 and 12 months of treatment to demonstrate the superiority of NU100 to placebo and the non-inferiority of NU100 to Betaferon®, respectively. Negative binomial regression will be used to compare the cumulative number of new CALs at the end of Month 4 and at the end of Month 12. |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of annualized relapse rates | at 12 months |
Countries
Belarus, Bulgaria, Croatia, Georgia, Hungary, Italy, Lebanon, Poland, Russia, Serbia, Spain, Ukraine
Outcome results
None listed