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Completed

NCT Number: NCT02738775

Phase IIa Study of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis

This study evaluates the use of single agent ublituximab, a novel monoclonal antibody, in participants with relapsing forms of multiple sclerosis.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

TG Therapeutics Investigational Trial Site, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of relapsing multiple sclerosis
  • Active disease
  • Greater than or equal to (≥) 2 relapses in prior 2 years or 1 relapse in the year prior to screening and/or ≥1 gadolinium (Gd) enhancing lesion

Exclusion criteria

  • Treatment with anti-cluster of differentiation 20 (CD20) monoclonal antibody within the last 12 months
  • Treatment with alemtuzumab within the last 12 months
  • Pregnant or nursing mothers

Treatment and study plan

Ublituximab

Biological

Administered as an IV infusion.

Other names: TG-1101

Placebo

Drug

Primary outcomes

  1. Responder Rate of B-Cell Depletion at Week 4

    Time frame: Week 4

    Responders Rate is defined as percentage of participants with greater than or equal to (≥) 95% reduction of B cells (cluster of differentiation 19 positive [CD19+] cells) within 2 weeks after the second infusion (Day 15).

Secondary outcomes

  1. Number of New Gadolinium (Gd)-Enhancing T1 Lesions at Weeks 24 and 48

    Time frame: Weeks 24 and 48

    The Gd-enhancing T1 lesions were evaluated using magnetic resonance imaging (MRI) technique.

  2. Number of New or Enlarging T2 Lesions at Weeks 24 and 48

    Time frame: Weeks 24 and 48

    The new or enlarging T2 lesions were evaluated using MRI technique.

  3. Annualized Relapse Rate (ARR)

    Time frame: Week 48

    ARR at Week 48 is calculated as the ratio of the sum of all participants confirmed relapse counts divided by the sum of all participants treatment duration (in years).

  4. Relapse Rate Reduction (RRR)

    Time frame: Baseline to Week 48

    RRR was calculated as the percentage reduction from baseline ARR to ARR at Week 48.

  5. Percentage of Relapse Free Participants

    Time frame: Week 48

    Participant was considered as free of clinical relapse if participant had no confirmed clinical relapse before treatment discontinuation/until end of Week 48. Relapses are defined as the occurrence of new or worsening neurological symptoms attributable to multiple sclerosis (MS), and immediately preceded by a stable or improving neurological state of at least 30 days.

  6. Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells

    Time frame: Baseline, Week 1 Day 2, Week 2, Week 3 Day 15, Weeks 4, 8, 12, 16, 20, 24, Week 24 plus 2 days, Weeks 25, 28, 36, 40, 44 and 48

    Cluster of Differentiation (CD)19 is a marker of B cells, the protein has been used to diagnose cancers that arise from this type of cell - notably B cell lymphomas, acute lymphoblastic leukemia (ALL), and chronic lymphocytic leukemia (CLL). The majority of B cell malignancies express normal to high levels of CD19. Memory B cell is a type of B lymphocyte that forms part of the adaptive immune system. These cells develop within germinal centers of the secondary lymphoid organs. Their function is to memorize the characteristics of the antigen that activated their parent B cell during initial infection such that if the memory B cell later encounters the same antigen, it triggers an accelerated and robust secondary immune response. A naive B cell is a B cell that has not been exposed to an antigen. Once exposed to an antigen, the naive B cell either becomes a memory B cell or a plasma cell that secretes antibodies specific to the antigen that was originally bound.

  7. Change From Baseline in Sustained B Cell

    Time frame: Baseline to pre-dose at Week 24 and Week 48

    Sustained B cell reduction is defined as B-cell reductions achieved on pre-dose at Week 24 and Week 48.

  8. Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive)

    Time frame: Baseline, Week 1 Day 2, Week 2, Week 3 Day 15, Weeks 4, 8, 12, 16, 20, 24, Week 24 Plus 2 Days, Weeks 25, 28, 36, 40, 44 and 48

    A blood sample was collected and was sent to the laboratory for analysis of CD4+.

  9. Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive)

    Time frame: Baseline, Week 1 Day 2, Week 2, Week 3 Day 15, Weeks 4, 8, 12, 16, 20, 24, Week 24 Plus 2 Days, Weeks 25, 28, 36, 40, 44 and 48

    A blood sample was collected and was sent to the laboratory for analysis of CD8+.

  10. Additional Immune Profiling-Interleukin 10 (IL10)

    Time frame: Baseline, Weeks 2, 4, 12, 20, 24, 25, 36, 44 and 48

    A blood sample was collected and was sent to the laboratory for analysis of IL-10. IL-10 is an anti-inflammatory cytokine that maintains the balance of the immune response, allowing the clearance of infection while minimizing damage to the host.

  11. Additional Immune Profiling-Natural Killer (NK) Cells

    Time frame: Baseline, Week 1 Day 2, Week 2, Week 3 Day 15, Weeks 4, 8, 12, 16, 20, 24, Week 24 Plus 2 Days, Weeks 25, 28, 36, 40, 44 and 48

    A blood sample was collected and was sent to the laboratory for analysis of NK cells. Percentage of NK cells per ml of blood. NK cells are lymphocytes with the ability to kill tumor cells without deliberate immunization or activation.

  12. Pharmacokinetic Parameter: Plasma Concentration of Ublituximab

    Time frame: Day 1 (pre-dose); Week 2; Day 15 (pre-dose); Weeks 4, 24 (pre-dose) and 25

    Plasma concentration is defined as the measured concentration of ublituximab.

Sponsors and collaborators

Lead sponsor

TG Therapeutics, Inc.

Industry

Registry information

Official study title

A Placebo-Controlled Multi-Center Phase IIa Dose Finding Study of Ublituximab, a Third-Generation Anti-CD20 Monoclonal Antibody, in Patients With Relapsing Forms of Multiple Sclerosis.

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Apr 14, 2016
Registry last updated
Jul 15, 2021

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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