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NCT Number: NCT02330965

Mechanistic Studies of Phase III Trial With BAF312 in Secondary Progressive Multiple Sclerosis

The primary goal of this study is to evaluate the effects of BAF312 (siponimod) on select immune and neuronal (nerve) cells by examining laboratory specimens (blood and/or spinal fluid) at multiple time points, prior to, and following the initiation of BAF312 or placebo treatment, in patients with Secondary Progressive Multiple Sclerosis (SPMS) who are enrolled in a clinical trial (NCT01665144) to evaluate the effectiveness and safety of BAF312.

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Key information

Conditions

Secondary Progressive Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Chronic Disease Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Disease Attributes Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Chronic Progressive Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Jordan Research & Education Institute: Sutter Alta Bates Summit, Berkeley, California, United States

Loading trial locations.

About this study

This study is complementary to a multi-center, randomized, double-blind,parallel-group, placebo-controlled, variable treatment duration study comparing the efficacy and safety of BAF312 to placebo in patients with SPMS (NCT01665144). Investigators will explore both immunological and neuroprotective mechanisms of BAF312 (siponimod), a novel agent in the setting of a SPMS clinical trial.

This study is part of a multi-center study, with the University of Michigan serving as the central site.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants enrolled in the multicenter, randomized, double-blind, parallel-group, placebo-controlled, variable treatment duration study comparing the efficacy and safety of BAF312 to placebo in patients with Secondary Progressive Multiple Sclerosis (SPMS) Protocol No. CBAF312A2304 (sponsored by Novartis). Refer to ClinicalTrials.gov record NCT01665144.
  • Subjects enrolled at one of the participating AMS04 study sites located in the United States.
  • Subject must be able to provide written informed consent.

Exclusion criteria

  • Subjects with severe bleeding disorders, platelet count less than (<)50,000/microliters (μL), and/or who are currently on full anticoagulant therapy will be excluded from the optional CSF collections.

Treatment and study plan

Blood draw

Procedure

Blood draws (65 mLs [~4 tablespoons] per blood draw) at 4 time points: Prior to study medication initiation, and at +6, +12 and+24 months post treatment initiation.

Other names: Phlebotomy, Venipuncture

CSF collection by lumbar puncture (Optional)

Procedure

For participants who volunteer to donate CSF samples: up to 25 mLs (<2 tablespoons): prior to study medication initiation, and at month 24 post treatment initiation.

Other names: CSF by LP, cerebrospinal fluid collected by lumbar puncture

Primary outcomes

  1. Change in frequency of MBP-reactive Th17 cells

    Time frame: From baseline to the follow-up time points (Open label phase + 6 months and OLP +12 months).

    Evaluation (BAF312 versus placebo) of dominant cytokines produced by myelin basic protein (MBP)-stimulated peripheral blood mononuclear cells (PBMCs), measured by ELISpot.

Secondary outcomes

  1. Change in frequency of polyclonal CD4+ Th17, Th1, Th2, and Treg cells

    Time frame: From baseline to the follow-up time points (Open label phase + 6 months and OLP +12 months).

    Compare BAF312 and Placebo (Control) Groups

  2. Change in chemokine and cytokines levels

    Time frame: From baseline to the follow-up time points (Open label phase + 6 months and OLP +12 months).

    Compare BAF312 and Placebo (Control) Groups

  3. Change in Regulatory B Cells

    Time frame: From baseline to the follow-up time points (Open label phase + 6 months and OLP +12 months).

    Compare BAF312 and Placebo (Control) Groups

  4. Changes of clinical status and lymphocyte subgroups

    Time frame: From baseline to the follow-up time points (Open label phase + 6 months and OLP +12 months).

    Compare BAF312 and Placebo (Control) Groups

Sponsors and collaborators

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Nih

Collaborators

  • Autoimmunity Centers of Excellence
  • Novartis Pharmaceuticals

Registry information

Official study title

Mechanistic Studies of Phase III Trial With BAF312 in Secondary Progressive Multiple Sclerosis (AMS04)

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jan 5, 2015
Registry last updated
Nov 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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