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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02038049
• Date of registration: 14/01/2014
• Prospective Registration: No
• Primary sponsor: Novartis Pharmaceuticals
• Public title: A Study to Assess the Effect of a Single Infusion of VAY736 on Disease Activity 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: December 20, 2013
• Target sample size: 8
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02038049
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

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

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Relapse Remitting Multiple Sclerosis

Intervention(s)

Drug: VAY736

Drug: Placebo

Primary Outcome(s)

Number of New T1-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 8, 12 and 16 [Time Frame: Week 8, Week 12, Week 16]

Secondary Outcome(s)

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]

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]

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]

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)]

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]

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]

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]

Secondary ID(s)

CVAY736X2202

2013-002324-16

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 30/10/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02038049