A Study to Assess the Effect of a Single Infusion of VAY736 on Disease Activity in Patients With Relapsing-remitting Multiple Sclerosis

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-20

Study Completion Date

2018-09-13

Brief Summary

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This was a randomized, partially blinded, placebo-controlled, non-confirmatory study to assess the effects of a single infusion of VAY736 on disease activity as measured by brain MRI scans in patients with relapsing-remitting multiple sclerosis (RRMS).

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Detailed Description

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The study was planned to be conducted in approximately 96 patients. However, after enrolling 8 patients, the recruitment was terminated based on strategic considerations.

Conditions

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Relapse Remitting Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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VAY736

Intravenous infusion of VAY736

Group Type EXPERIMENTAL

VAY736

Intervention Type DRUG

Single intravenous infusion of VAY736 (10 mg/kg)

Placebo to VAY736

Matching placebo (infusion bag) administered intravenously. Placebo randomized patients were offered optional VAY736 administration after week 16

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo to VAY736

Interventions

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VAY736

Single intravenous infusion of VAY736 (10 mg/kg)

Intervention Type DRUG

Placebo

Placebo to VAY736

Intervention Type DRUG

Other Intervention Names

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Lanalumab

Eligibility Criteria

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Inclusion Criteria

* Male and female patients aged 18 to 55 years.
* 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 ), 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.

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.
* Score "yes" on item 4 or item 5 of the Suicidal Ideation section of the C-SSRS, if this ideation occurred in the past 6 months, or "yes" on any item of the Suicidal Behavior section, except for the "Non-Suicidal Self-Injurious Behavior" (item also included in the Suicidal Behavior section), if this behavior occurred in the past 2 years.
* Women of child-bearing potential and Pregnant or nursing (lactating) women.
* Screening CBC (complete blood count) laboratory values as follows:
* Hemoglobin levels below 10.0 g/dL
* Total leukocyte count less than 3,000 cells/µL
* Neutropenia, defined as absolute neutrophil counts less than 1500 cells/mm3
* Platelets less than 100,000/µL

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No