Clinical trial NCT02738775: Phase IIa Study of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis
Lead sponsor: TG Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2016-04-14
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Responder Rate of B-Cell Depletion at Week 4
timeFrame: Week 4
Secondary outcomes:
measure: Number of New Gadolinium (Gd)-Enhancing T1 Lesions at Weeks 24 and 48
timeFrame: Weeks 24 and 48
measure: Number of New or Enlarging T2 Lesions at Weeks 24 and 48
timeFrame: Weeks 24 and 48
measure: Annualized Relapse Rate (ARR)
timeFrame: Week 48
measure: Relapse Rate Reduction (RRR)
timeFrame: Baseline to Week 48
measure: Percentage of Relapse Free Participants
timeFrame: Week 48
measure: Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells
timeFrame: 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
measure: Change From Baseline in Sustained B Cell
timeFrame: Baseline to pre-dose at Week 24 and Week 48
measure: Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive)
timeFrame: 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
measure: Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive)
timeFrame: 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
measure: Additional Immune Profiling-Interleukin 10 (IL10)
timeFrame: Baseline, Weeks 2, 4, 12, 20, 24, 25, 36, 44 and 48
measure: Additional Immune Profiling-Natural Killer (NK) Cells
timeFrame: 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
measure: Pharmacokinetic Parameter: Plasma Concentration of Ublituximab
timeFrame: Day 1 (pre-dose); Week 2; Day 15 (pre-dose); Weeks 4, 24 (pre-dose) and 25
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Arizona
city: Pasadena
country: United States
facility: TG Therapeutics Investigational Trial Site
state: California
city: Torrance
country: United States
facility: TG Therapeutics Investigational Trial Site
state: California
city: Aurora
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Colorado
city: Fort Collins
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Colorado
city: Lexington
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Kentucky
city: Teaneck
country: United States
facility: TG Therapeutics Investigational Trial Site
state: New Jersey
city: Akron
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Ohio
city: Columbus
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Ohio
city: Knoxville
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Tennessee
city: Round Rock
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Texas
city: San Antonio
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Texas
Study officials:
affiliation: Central Texas Neurology
name: Edward Fox, MD, PhD
role: STUDY_CHAIR
References: