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

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ClinicalTrials.gov Identifier: NCT02038049
Recruitment Status : Terminated (The study recruitment was terminated based on strategic considerations after 8 patients were enrolled.)
First Posted : January 16, 2014
Results First Posted : October 30, 2019
Last Update Posted : October 30, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Relapse Remitting Multiple Sclerosis Drug: VAY736 Drug: Placebo Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : December 20, 2013
Actual Primary Completion Date : May 5, 2015
Actual Study Completion Date : September 13, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: VAY736
Intravenous infusion of VAY736
Drug: VAY736
Single intravenous infusion of VAY736 (10 mg/kg)
Other Name: Lanalumab

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




Primary Outcome Measures :
  1. Number of New T1-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 8, 12 and 16 [ Time Frame: Week 8, Week 12, Week 16 ]
    The effect of VAY736, compared to placebo on the cumulative number of new gadolinium [Gd]-enhancing lesions on T1-weighted brain MRI scans in relapsing-remitting multiple sclerosis (RRMS) patient population at weeks 8, 12 and 16. Only descriptive statistics performed.


Secondary Outcome Measures :
  1. Number of All T1-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 4, 8, 12 and 16 [ Time Frame: Week 4, Week 8, Week 12, Week 16 ]
    Magnetic resonance imaging (MRI) scanning of the brain was performed at screening/baseline, week 4, week 8, week 12 and week 16 to assess all T1-weighted Gadolinium (Gd) enhancing lesions. Each MRI scan was reviewed by a local neuro-radiologist. Only descriptive statistics performed.

  2. Number of New T1-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 4, 8, 12 and 16 [ Time Frame: Week 4, Week 8, Week 12, Week 16 ]
    Magnetic resonance imaging (MRI) scanning of the brain was performed at screening/baseline, week 4, week 8, week 12 and week 16 to assess all new T1-weighted Gadolinium (Gd) enhancing lesions. Each MRI scan was reviewed by a local neuro-radiologist. Only descriptive statistics performed.

  3. Number of New or Enlarging T2-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 4, 8, 12 and 16 [ Time Frame: Week 4, Week 8, Week 12, Week 16 ]
    Magnetic resonance imaging (MRI) scanning of the brain was performed at screening/baseline, week 4, week 8, week 12 and week 16 to assess T2 hyperintense lesions (new or enlarging T2-weighted lesions). Each MRI scan was reviewed by a local neuro-radiologist. Only descriptive statistics performed.

  4. T2 Burden of Disease (Total Volume of T2-weighted Lesions) at Weeks 4, 8, 12 and 16. [ Time Frame: Week 4, Week 8, Week 12, Week 16 ]
    Magnetic resonance imaging (MRI) scanning of the brain was performed at screening/baseline, week 4, week 8, week 12 and week 16 to assess T2 burden of disease. Each MRI scan was reviewed by a local neuro-radiologist. Only descriptive statistics performed.

  5. Number of Subjects Without Any New MRI Disease Activity at Weeks 4, 8, 12 and 16. [ Time Frame: Week 4, Week 8, Week 12, Week 16 ]
    Magnetic resonance imaging (MRI) scanning of the brain was performed at screening/baseline, week 4, week 8, week 12 and week 16 to assess patients without any new MRI disease activity (no new Gd-enhancing lesions nor new or enlarging T2 lesions). Each MRI scan was reviewed by a local neuro-radiologist. Only descriptive statistics performed.

  6. Proportion of Relapse-free Patients Over the 16 Weeks of the Treatment Period. [ Time Frame: Week 0 (Day 1), Week 4, Week 8, Week 12, Week 16 ]
    A relapse is defined as the appearance of a new neurological abnormality, or worsening of previously stable, or improving pre-existing neurological abnormality, separated by at least 30 days from the onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (<37.5 C) or infection. A relapse was considered confirmed when confirmed by an Extended disability status scale (EDSS)-certified physician who was not involved in the treatment of the patient, was blinded to treatment allocation, and had no access to patient medical records. It was recommended that this occurs within 5 days of the onset of symptoms. A relapse was confirmed when it was accompanied by an increase of at least half a point (0.5) on the EDSS or an increase of 1 point on two different Functional Systems (FS) of the EDSS or 2 points on one of the FS (excluding Bowel/Bladder or Cerebral FS). Only descriptive statistics performed.

  7. Number of Participants With On-Treatment Adverse Events, Serious Adverse Event, and Death [ Time Frame: 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) ]
    Analysis of absolute and relative frequencies for treatment emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC) to demonstrate that VAY736 is safe for the treatment of patients with relapsing-remitting multiple sclerosis through the monitoring of relevant clinical and laboratory safety parameters. Only descriptive statistics performed.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02038049


Locations
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United States, California
Novartis Investigative Site
Long Beach, California, United States, 90806
Novartis Investigative Site
San Diego, California, United States, 92103
Czechia
Novartis Investigative Site
Hradec Kralove, Czechia, 501 03
Ukraine
Novartis Investigative Site
Kharkiv, Ukraine, 61068
Novartis Investigative Site
Lviv, Ukraine, 79010
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02038049    
Other Study ID Numbers: CVAY736X2202
2013-002324-16 ( EudraCT Number )
First Posted: January 16, 2014    Key Record Dates
Results First Posted: October 30, 2019
Last Update Posted: October 30, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Multiple Sclerosis
Relapsing-Remitting Multiple Sclerosis
Magnetic Resonance Imaging
VAY736
Lanalumab
monoclonal antibody
gadolinium [Gd]-enhancing lesions
B-Cell
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases