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

NCT01464905 | Unknown Phase 3

• 1 other identifier: CP-NU100-01.00
• Study Type: interventional
• Target: 500
• Locations: 12 countries
• Sites: 12

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.

Conditions

Relapsing Remitting Multiple Sclerosis

Keywords

RRMS

Outcome Measures

Primary Outcomes (1)

• New CALs after 4 months of treatment based on the MRI outcomes obtained at 4 and 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.

  2 to 12 months

Secondary Outcomes (1)

• Incidence of annualized relapse rates

  at 12 months

Study Arms (3)

NU100

EXPERIMENTAL

Biological: NU100

Placebo

PLACEBO COMPARATOR

Biological: Placebo

recombinant human interferon beta- 1b

ACTIVE COMPARATOR

Biological: rhIFN beta-1b

Interventions

NU100 BIOLOGICAL

0.25 mg SQ, every other day for 12 months

NU100

Placebo BIOLOGICAL

1 mL SQ, every other day for 4 months

Placebo

rhIFN beta-1b BIOLOGICAL

0.25 mg SQ, every other day for 12 months

recombinant human interferon beta- 1b

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Nuron Biotech Inc.: lead

Study Sites (12)

Unknown Facility

Minsk, Belarus

Location

Unknown Facility

Sofia, Bulgaria

Location

Unknown Facility

Zagreb, Croatia

Location

Unknown Facility

Tbilisi, Georgia

Location

Unknown Facility

Budapest, Hungary

Location

Unknown Facility

Rome, Italy

Location

Unknown Facility

Beirut, Lebanon

Location

Unknown Facility

Warsaw, Poland

Location

Unknown Facility

Moscow, Russia

Location

Unknown Facility

Belgrade, Serbia

Location

Unknown Facility

Barcelona, Spain

Location

Unknown Facility

Kiev, Ukraine

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Tracy L Goeken, M.D.

  Nuron Biotech

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2011
• First Posted: November 4, 2011
• Study Start: October 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2014
• Last Updated: September 23, 2013

Record last verified: 2013-09

Locations

IT (1); RU (1); ES (1); UA (1); SE (1); BE (1); CR (1); PL (1); GE (1); BU (1); HU (1); LE (1)