A Phase 3, Multicenter, Double-blind,Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of NU100 in Patients With Relapsing Forms of Multiple Sclerosis
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Nuron Biotech Inc.
- Enrollment
- 500
- Locations
- 12
- Primary Endpoint
- New CALs after 4 months of treatment based on the MRI outcomes obtained at 4 and 12 months
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts 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):
- •Female or male patients, aged between 18 and 60 years, inclusive
- •Signed and dated statement of informed consent
- •Diagnosis of RRMS according to McDonald's Criteria - revision 2010 (Polman et al., 2011)
- •Interferon (IFN) beta-1b naïve
- •Expanded Disability Status Scale (EDSS) score of < 5.5
- •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.
- •No relapse in the 4 weeks prior to the screening visit (V-1).
- •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 exclusion criteria at screening (V-1) and baseline (V0) will not be enrolled in the study:
- •Relapse at the baseline visit (V0) or occurring within 4 weeks prior to the screening visit (V-1)
- •Intake of glatiramer acetate within 3 months prior to the screening (V-1) visit
- •Intake of previous immunotherapy or immunosuppressant treatment, within 4 months prior to the screening (V-1) visit
- •Intake of or previously received therapy with cladribine or alemtuzumab
- •An active viral, bacterial, or systemic fungal infection within 1 week of baseline (V0)
- •Use of systemic steroids within 3 weeks prior to the screening (V-1) MRI
- •Progressive disease
- •Level of liver enzymes 2.5 x the upper limit of normal
- •Abnormal renal function (estimated Glomerular Filtration Rate [eGFR] < 60 ml/min/1.73 m2 )
- •Positive serology or history for Hepatitis B, C, or human immunodeficiency virus (HIV)
- •Serious or acute coronary diseases, defined by at least 1 of the following conditions:
- •Clinical symptoms of ischemic heart disease
- •ST elevation or depression > 2 mm on the electrocardiogram (ECG)
- •Clinical symptoms of cardiac failure and/or current medical treatment for cardiac failure
- •Severe ventricular arrhythmia (frequent premature ventricular beats)
- •Atrioventricular block at third level
- •Chronic use of non-steroidal anti-inflammatory drugs
- •History of any of the following:
- •Severe depression or suicide attempt
- •Uncontrolled seizure disorder
- •Cancer, excluding adequately treated basal cell carcinoma of the skin or adequately treated in situ carcinoma of the cervix
- •Previous contrast reaction to gadolinium or any other contraindications to MRI (e.g., metal in the eye, pacemakers, aneurysm clip)
- •Allergy to human albumin or to mannitol
- •Excessive alcohol use or illicit drug use
- •Women who are breast feeding, pregnant, or planning to become pregnant, or are unwilling to use an effective birth control method while on study
- •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
- •Participation in any other study involving investigational or marketed products, concomitantly or within 30 days prior to entry in the study Current participation in other clinical trials
Arms & Interventions
recombinant human interferon beta- 1b
Intervention: rhIFN beta-1b (Biological)
Placebo
Intervention: Placebo (Biological)
NU100
Intervention: NU100 (Biological)
Outcomes
Primary Outcomes
New CALs after 4 months of treatment based on the MRI outcomes obtained at 4 and 12 months
Time Frame: 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 Outcomes
- Incidence of annualized relapse rates(at 12 months)