Clinical trial NCT03277248: Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS)
Official title: Phase III: UbLiTuximab in Multiple Sclerosis Treatment Effects (ULTIMATE II STUDY)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Relapsing Multiple Sclerosis (RMS)
Lead sponsor: TG Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2017-09-11
Enrollment: 545
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, multi-center, double-blinded, active-controlled study
Primary purpose: TREATMENT

Brief summary: This study determines the Annualized Relapse Rate (ARR) in participants with RMS after 96 weeks (approximately 2 years) treatment with intravenous (IV) infusion of ublituximab/oral placebo compared to 14 mg oral teriflunomide/IV placebo.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of relapsing multiple sclerosis (RMS) (McDonald Criteria 2010)
* Active disease
* Expanded disability status scale (EDSS) 0 - 5.5 (inclusive) at screening

Exclusion Criteria:

* Treatment with prior Anti-cluster of differentiate 20 (CD20) or other B cell directed treatment
* Treatment with the following therapies at any time prior to randomization: alemtuzumab, natalizumab, teriflunomide, leflunomide and Stem cell transplantation
* Diagnosed with primary progressive multiple sclerosis (PPMS)
* Pregnant or nursing

Primary outcomes:
measure: Annualized Relapse Rate (ARR)
timeFrame: Up to 96 weeks
Secondary outcomes:
measure: Total Number of Gadolinium (Gd)-Enhancing T1-Lesions Per Magnetic Resonance Imaging (MRI) Scan Per Participant
timeFrame: Weeks 12, 24, 48, and 96
measure: Total Number of New and Enlarging T2 Hyperintense Lesions (NELs) Per MRI Scan Per Participant
timeFrame: Weeks 24, 48, and 96
measure: Time to Confirmed Disability Progression (CDP) for at Least 12 Weeks
timeFrame: Up to Week 96
measure: Percentage of Participants With No Evidence of Disease Activity (NEDA)
timeFrame: From Week 24 to Week 96
measure: Percentage of Participants With Impaired Symbol Digit Modalities Test (SDMT)
timeFrame: Baseline to Week 96
measure: Percent Change From Baseline in Brain Volume
timeFrame: Baseline to Week 96
measure: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
timeFrame: From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: TG Therapeutics RMS Investigational Trial site
state: Arizona
city: Aurora
country: United States
facility: TG Therapeutics RMS Investigational Trial Site
state: Colorado
city: Tampa
country: United States
facility: TG Therapeutics RMS Investigational Trial Site
state: Florida
city: Lexington
country: United States
facility: TG Therapeutics RMS Investigational Trial Site
state: Kentucky
city: Chesterfield
country: United States
facility: TG Therapeutics RMS Investigational Trial Site
state: Missouri
city: Las Vegas
country: United States
facility: TG Therapeutics RMS Investigational Trial Site
state: Nevada
city: Teaneck
country: United States
facility: TG Therapeutics RMS Investigational Trial Site
state: New Jersey
city: Albuquerque
country: United States
facility: TG Therapeutics RMS Investigational Trial Site
state: New Mexico
city: Patchogue
country: United States
facility: TG Therapeutics RMS Investigational Trial Site
state: New York
city: Columbus
country: United States
facility: TG Therapeutics RMS Investigational Trial site
state: Ohio
city: Pittsburgh
country: United States
facility: TG Therapeutics RMS Investigational Trial Site
state: Pennsylvania
city: San Antonio
country: United States
facility: TG Therapeutics RMS Investigational Trial site
state: Texas
city: Seattle
country: United States
facility: TG Therapeutics RMS Investigational Trial site
state: Washington
Study officials:
References:
citation: Steinman L, Fox E, Hartung HP, Alvarez E, Qian P, Wray S, Robertson D, Huang D, Selmaj K, Wynn D, Cutter G, Mok K, Hsu Y, Xu Y, Weiss MS, Bosco JA, Power SA, Lee L, Miskin HP, Cree BAC; ULTIMATE I and ULTIMATE II Investigators. Ublituximab versus Teriflunomide in Relapsing Multiple Sclerosis. N Engl J Med. 2022 Aug 25;387(8):704-714. doi: 10.1056/NEJMoa2201904.