A clinical trial to test if NU100 is safe and can treat patient with relapsing types of multiple sclerosis
- Conditions
- relapsing forms of multiple sclerosisMedDRA version: 14.1Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2011-002683-24-IT
- Lead Sponsor
- RON BIOTECH INC.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 500
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 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 (V1) 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)
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 500
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Patients meeting any of the following exclusion criteria at screening (V- 1) and baseline (V0) will not be enrolled in the study: 1.Relapse at the baseline visit (V0) or occurring within 4 weeks prior to the screening visit (V-1) 2.Intake of glatiramer acetate within 3 months prior to the screening (V- 1) visit 3.Intake of previous immunotherapy or immunosuppressant treatment, within 4 months prior to the screening (V-1) visit 4.Intake of or previously received therapy with cladribine or alemtuzumab 5.An active viral, bacterial, or systemic fungal infection within 1 week of baseline (V0) 6.Use of systemic steroids within 3 weeks prior to the screening (V-1) MRI 7.Progressive disease
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the safety and efficacy of NU100 in patients with relapsing remitting multiple sclerosis 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.;Secondary Objective: see protocol;Primary end point(s): •Cohort 1: new CALs after 4 months of treatment based on the MRI outcomes obtained at Months 2, 3, and 4 •Cohort 2: new CALs over 12 months of treatment based on the MRI outcomes obtained at Months 3, 6, 9, and 12;Timepoint(s) of evaluation of this end point: as per protocol
- Secondary Outcome Measures
Name Time Method Secondary end point(s): •Incidence of annualized relapse rates •Proportion of relapse-free patients at 12 months •Incidence and severity of all drug related flu-like symptoms (FLS) during the first 4 months of study participation in all patients. •Incidence of antibody (neutralizing antibodies [NABs]/binding antibodies [BABs]) formation against IFN beta-1b •Changes from baseline in the EDSS score after 3, 4, 6, 9, and 12 months of treatment •Sustained change in EDSS measured for at least 3 months •Changes from baseline in the Hamilton Depression Scale (HDS) score after 4, 6, 9, and 12 months of treatment •Changes from baseline in the Multiple Sclerosis Impact Scale-29 (MSIS- 29) score after 4, 6, 9, and 12 months of treatment;Timepoint(s) of evaluation of this end point: as per protocol