Phase 3 Study to Evaluate Efficacy and Safety of NU100 in Patients With Relapsing Remitting Multiple Sclerosis (RRMS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Nuron Biotech Inc.
ClinicalTrials.gov Identifier:
NCT01464905
First received: October 31, 2011
Last updated: September 20, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Relapsing Remitting Multiple Sclerosis
Biological: NU100
Biological: Placebo
Biological: rhIFN beta-1b
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Nuron Biotech Inc.:

Primary Outcome Measures:
  • New CALs after 4 months of treatment based on the MRI outcomes obtained at 4 and 12 months [ Time Frame: 2 to 12 months ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Incidence of annualized relapse rates [ Time Frame: at 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: October 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NU100 Biological: NU100
0.25 mg SQ, every other day for 12 months
Placebo Comparator: Placebo Biological: Placebo
1 mL SQ, every other day for 4 months
Active Comparator: recombinant human interferon beta- 1b Biological: rhIFN beta-1b
0.25 mg SQ, every other day for 12 months

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 (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 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] < 60 ml/min/1.73 m2 )
  10. Positive serology or history for Hepatitis B, C, or human immunodeficiency virus (HIV)
  11. 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
  12. Chronic use of non-steroidal anti-inflammatory drugs
  13. 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)
  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 Current participation in other clinical trials
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01464905

Locations
Belarus
XX
Minsk, Belarus
Bulgaria
XX
Sofia, Bulgaria
Croatia
XX
Zagreb, Croatia
Georgia
XX
Tbilisi, Georgia
Hungary
XX
Budapest, Hungary
Italy
XX
Rome, Italy
Lebanon
XX
Beirut, Lebanon
Poland
XX
Warsaw, Poland
Russian Federation
XX
Moscow, Russian Federation
Serbia
XX
Belgrade, Serbia
Spain
XX
Barcelona, Spain
Ukraine
XX
Kiev, Ukraine
Sponsors and Collaborators
Nuron Biotech Inc.
Investigators
Study Director: Tracy L Goeken, M.D. Nuron Biotech
  More Information

No publications provided

Responsible Party: Nuron Biotech Inc.
ClinicalTrials.gov Identifier: NCT01464905     History of Changes
Other Study ID Numbers: CP-NU100-01.00
Study First Received: October 31, 2011
Last Updated: September 20, 2013
Health Authority: European Union: European Medicines Agency

Keywords provided by Nuron Biotech Inc.:
RRMS

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 22, 2014