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

NCT02038049 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: CVAY736X22022013-002324-16
• Study Type: interventional
• Target: 8
• Locations: 3 countries
• Sites: 5

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).

Conditions

Relapse Remitting Multiple Sclerosis

Keywords

Multiple Sclerosis; Relapsing-Remitting Multiple Sclerosis; Magnetic Resonance Imaging; VAY736; Lanalumab; monoclonal antibody; gadolinium [Gd]-enhancing lesions; B-Cell

Outcome Measures

Primary Outcomes (1)

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

  Week 8, Week 12, Week 16

Secondary Outcomes (7)

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

  Week 4, Week 8, Week 12, Week 16

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

  Week 4, Week 8, Week 12, Week 16

• 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

• 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

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

  Week 4, Week 8, Week 12, Week 16

Study Arms (2)

VAY736

EXPERIMENTAL

Intravenous infusion of VAY736

Drug: VAY736

Placebo to VAY736

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

VAY736 DRUG

Single intravenous infusion of VAY736 (10 mg/kg)

Also known as: Lanalumab

VAY736

Placebo DRUG

Placebo to VAY736

Placebo to VAY736

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (5)

Novartis Investigative Site

Long Beach, California, 90806, United States

Location

Novartis Investigative Site

San Diego, California, 92103, United States

Location

Novartis Investigative Site

Hradec Králové, 501 03, Czechia

Location

Novartis Investigative Site

Kharkiv, 61068, Ukraine

Location

Novartis Investigative Site

Lviv, 79010, Ukraine

Location

Related Links

• A Plain Language Trial Summary is available on novartisclinicaltrials.com

MeSH Terms

Conditions

Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting

Interventions

ianalumab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Limitations and Caveats

After enrolling 8 patients, the recruitment was terminated based on strategic considerations.

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2014
• First Posted: January 16, 2014
• Study Start: December 20, 2013
• Primary Completion: May 5, 2015
• Study Completion: September 13, 2018
• Last Updated: January 5, 2021
• Results First Posted: October 30, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share

Locations

CZ (1); US (2); UA (2)