Study of efficacy and safety of VAY736 in patients with relapsing-remitting multiple sclerosis

• Register: EUCTR
• Last refreshed on: 22 October 2018
• Main ID: EUCTR2013-002324-16-CZ
• Date of registration: 08/01/2014
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: Study of efficacy and safety of VAY736 in patients with relapsing-remitting multiple sclerosis
• Scientific title: A randomized, partially blind, placebo-controlled, proof-of-concept study to assess the effect of a single infusion of VAY736 on disease activity as measured by brain MRI scans in patients with relapsing-remitting multiple sclerosis
• Date of first enrolment: 13/06/2014
• Target sample size: 96
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-002324-16
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: no; Parallel group: yes; Cross over: no; Other: yes; Other trial design description: Partially blind (Investigators and patients will be unblinded to treatment assignment after week 16); If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Czech Republic, Poland, Russian Federation, Ukraine, United States

Contacts

• Name: Informacní služba - klin.hodnocení
• Affiliation: Novartis s.r.o.

• Name: Informacní služba - klin.hodnocení
• Affiliation: Novartis s.r.o.

Key inclusion & exclusion criteria

Inclusion criteria:
-Male and female patients 18 to 55 years of age.
-Diagnosis of MS as defined by the 2010 revised McDonald criteria (Polman, et. al. 2011).
-A relapsing-remitting course of disease with:
at least 1 documented relapse during the previous 12 months (but not within 30 days prior to randomization as per criterion 6), or a positive Gd-enhancing lesion on brain MRI scan at screening.
-An Expanded Disability Status Scale (EDSS) score of 0-5.0 inclusive at screening.
-No evidence of a relapse within 30 days prior to randomization.

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 96
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
-A manifestation of another type of MS other than RRMS.
-Findings on screening or baseline brain MRI inconsistent with the diagnosis of MS.
-History of chronic disease of the immune system other than MS, or a known immunodeficiency syndrome.
-Unable to undergo MRI scans due to inter-alia, claustrophobia, incompatible cardiac pacemakers, ferromagnetic intracranial, Aneurysm clips, certain cochlear implants, and certain other ferromagnetic foreign bodies (e.g. tattoos containing metal) or electronic devices, or metallic implants incompatible with MRI.
-Unable to receive gadolinium-based MRI contrast agents due to a history of hypersensitivity to gadolinium-based contrast agents, renal insufficiency or impairment.
-Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during the course of the study and for 4 months following completion of the study.
-Have received total lymphoid irradiation, bone marrow transplantation, alemtuzumab, cladribine, cyclophosphamide, mitoxantrone, or other immunosuppressive treatments with effects lasting longer than 6 months (wash-out times for other registered or putative immunomodulators or immunosupressants apply)
- Patient may stop their current treatment only if considered not effective, not safe, or not tolerated by HCP and/or patient (for Czech Republic only)



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

Health Condition(s) or Problem(s) studied

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

relapsing-remitting multiple sclerosis
MedDRA version: 17.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders

Intervention(s)

Product Code: VAY736
Pharmaceutical Form: Powder for concentrate for solution for infusion
Current Sponsor code: VAY736
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: 8, 12, 16 weeks

Main Objective: To determine if a monoclonal antibody VAY736 can reduce disease activity in relapsing-remitting multiple sclerosis (RRMS) as compared to placebo.

Secondary Objective: To evaluate the safety and tolerability of VAY736 in patients with RRMS.
To evaluate the effect of VAY736 on additional parameters observed on brain MRI scans including:
- Number of all T1-weighted Gd-enhancing lesions
- Number of new or enlarging T2-weighted lesions
- T2 burden of disease (total volume of T2-weighted lesions)
- Proportion of subjects without any new MRI disease activity (no new Gd-enhancing lesions nor new or enlarging T2 lesions)
To evaluate the effect of VAY736 on the number of relapses

Primary end point(s): Cumulative number of new Gd-enhancing lesions.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 4, 8, 12, 16 weeks

Secondary end point(s): -Number of new and cumulative number of new T1-weighted Gd-enhancing lesions.
-Number of all T1-weighted Gd-enhancing lesions.
-Cumulative number of new or enlarging T2-weighted Gd-enhancing lesions.
-T2 burden of disease
-Proportion of subjects without any new MRI disease activity.
-The number of confirmed relapses at week 16
-Proportion of relapse-free patients over the 16 weeks of the treatment period
-Number of patients with adverse events

Secondary ID(s)

CVAY736X2202

Source(s) of Monetary Support

Novartis Pharma Services AG