Relapsing forms of multiple sclerosis
Conditions
Interventions
Product Code: NU100
Pharmaceutical Form: Solution for injection in pre-filled syringe
Current Sponsor code: NU100
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.
Sponsors
Nuron Biotech, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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 4.Interferon (IFN) beta-1b naïve 5.Expanded Disability Status Scale (EDSS) score of =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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 8.Level of liver enzymes 2.5 x the upper limit of normal 9.Abnormal renal function (estimated Glomerular Filtration Rate [eGFR] 2 mm on the electrocardiogram (ECG) c.Clinical symptoms of cardiac failure and/or current medical treatment for cardiac failure d.Severe ventricular arrhythmia (frequent premature ventricular beats) e.Atrioventricular block at third level 12.Chronic use of non-steroidal anti-inflammatory drugs 13.History of any of the following: a.Severe depression or suicide attempt b.Uncontrolled seizure disorder c.Cancer, excluding adequately treated basal cell carcinoma of the skin or adequately treated in situ carcinoma of the cervix d.Previous contrast reaction to gadolinium or any other contraindications to MRI (e.g., metal in the eye, pacemakers, aneurysm clip) 14.Allergy to human albumin or to mannitol 15.Excessive alcohol use or illicit drug use 16.Women who are breast feeding, pregnant, or planning to become pregnant, or are unwilling to use an effective birth control method while on study 17.Medical, psychiatric, or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study 18.Participation in any other study involving investigational or marketed products, concomitantly or within 30 days prior to entry in the study 19.Current participation in other clinical trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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;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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Belarus, Bulgaria, Croatia, Georgia, Hungary, Italy, Poland, Russian Federation, Spain, Ukraine
Contacts
Public ContactSheetal Haria
Worldwide Clinical Trials
Outcome results
None listed