A clinical trial to test if NU100 is safe and can treat patient with relapsing types of multiple sclerosis

• Register: EUCTR
• Last refreshed on: 23 December 2013
• Main ID: EUCTR2011-002683-24-HU
• Date of registration: 15/12/2011
• Prospective Registration: Yes
• Primary sponsor: Nuron Biotech, Inc.
• Public title: A clinical trial to test if NU100 is safe and can treat patient with relapsing types of multiple sclerosis
• Scientific 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
• Date of first enrolment: 02/03/2012
• Target sample size: 500
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-002683-24
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 3

Countries of recruitment

Belarus, Bulgaria, Croatia, Georgia, Hungary, Italy, Lebanon, Poland, Russian Federation, Spain, Ukraine

Contacts

• Name: Sheetal Haria
• Affiliation: Worldwide Clinical Trials

• Name: Sheetal Haria
• Affiliation: Worldwide Clinical Trials

Key inclusion & exclusion 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 < 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).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 500
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 or any monoclonal antibody therapy administration for treatment of MS
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:
a.Clinical symptoms of ischemic heart disease
b.ST elevation or depression > 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 (NSAIDs)
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
Current participation in other clinical trials



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

relapsing forms of multiple sclerosis

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

Product Code: NU100
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: n/a
CAS Number: n/a
Current Sponsor code: NU100
Other descriptive name: n/a
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.25-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use

Trade Name: Betaferon
Product Name: Betaferon
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: n/a
CAS Number: 145155-23-3
Current Sponsor code: n/a
Other descriptive name: INTERFERON BETA-1B
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.25-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: as per 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

Secondary Objective: see 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 Outcome(s)

Timepoint(s) of evaluation of this end point: as per protocol

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

Secondary ID(s)

2011-002683-24-ES

CP-NU100-01.00

Source(s) of Monetary Support

Nuron Biotech Inc