A Study to Assess the Effect of a Single Infusion of VAY736 on Disease

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

Stopped earlyPhase 2Relapsing MSNCT020380492013-002324-16

What it found

Stopped

The trial ended early for another reason (see below).

Reason given: The study recruitment was terminated based on strategic considerations after 8 patients were enrolled.

What was tested

Treatment tested

  • Ianalumab

    Tumor necrosis factor receptor superfamily member 13C binding agent

Placebo

  • Placebo

Results by group

Number of New T1-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 8, 12 and 16

Week 8, Week 12, Week 16

GroupValueIntervalNumber analysed
VAY7365 Lesions4
Placebo to VAY7361 Lesions4
VAY7365 Lesions4
Placebo to VAY7362 Lesions4
VAY7366 Lesions4
Placebo to VAY7363 Lesions4

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
VAY736 Administered at Visit 2 (Day 1)40 (0.0%)0
VAY736 Administered at Visit 7 (Week 16 - Week 17)40 (0.0%)0
Placebo Administered at Visit 240 (0.0%)0

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Number of New T1-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 8, 12 and 16

    Week 8, Week 12, Week 16

    MRI lesions

  • Cumulative number of new Gd-enhancing lesions.

    MRI lesions

Other measures (8)

  • Number of All T1-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 4, 8, 12 and 16

    Week 4, Week 8, Week 12, Week 16

    MRI lesions

  • Number of New T1-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 4, 8, 12 and 16

    Week 4, Week 8, Week 12, Week 16

    MRI lesions

  • Number of New or Enlarging T2-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 4, 8, 12 and 16

    Week 4, Week 8, Week 12, Week 16

    MRI lesions

  • T2 Burden of Disease (Total Volume of T2-weighted Lesions) at Weeks 4, 8, 12 and 16.

    Week 4, Week 8, Week 12, Week 16

    MRI lesions

  • Number of Subjects Without Any New MRI Disease Activity at Weeks 4, 8, 12 and 16.

    Week 4, Week 8, Week 12, Week 16

    MRI lesions

  • Proportion of Relapse-free Patients Over the 16 Weeks of the Treatment Period.

    Week 0 (Day 1), Week 4, Week 8, Week 12, Week 16

    Disability progressionRelapsesBladder, bowel and sexual function

  • Number of Participants With On-Treatment Adverse Events, Serious Adverse Event, and Death

    From first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216)

    Safety

  • -Number of new and cumulative number of new T1-weighted Gd-enhancing lesions.

    MRI lesions

Who could take part

Relapsing MS · 18 to 55 · EDSS 0 to 5.0

Show the full criteria

Inclusion criteria

Key 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. Key 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

Exclusion criteria

Not separately supplied in the registry.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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).

Papers

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    History

      1. Started

        Dec 2013

      2. Main results due

        May 2015

      3. Finished

        Sept 2018

      4. Results posted

        Oct 2019

      Assembled by software from public sources.