- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01464905
Phase 3 Study to Evaluate Efficacy and Safety of NU100 in Patients With Relapsing Remitting Multiple Sclerosis (RRMS)
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Minsk, Belarus
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Sofia, Bulgaria
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Zagreb, Croatia
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Tbilisi, Georgia
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Budapest, Hungary
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Rome, Italy
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Beirut, Lebanon
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Warsaw, Poland
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Moscow, Russian Federation
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Belgrade, Serbia
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Barcelona, Spain
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Kiev, Ukraine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Placebo
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1 mL SQ, every other day for 4 months
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Experimental: NU100
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0.25 mg SQ, every other day for 12 months
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Active Comparator: recombinant human interferon beta- 1b
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0.25 mg SQ, every other day for 12 months
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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New CALs after 4 months of treatment based on the MRI outcomes obtained at 4 and 12 months
Time Frame: 2 to 12 months
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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.
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2 to 12 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Incidence of annualized relapse rates
Time Frame: at 12 months
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at 12 months
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Tracy L Goeken, M.D., Nuron Biotech
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CP-NU100-01.00
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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