Clinical trial NCT03277261: Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS) ( ULTIMATE 1 )
Official title: Phase III: UbLiTuximab In Multiple Sclerosis Treatment Effects (ULTIMATE I 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: 549
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:

* 18-55 age
* Diagnosis of 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 MS (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: Week 24 up to Week 96
measure: Percentage of Participants With Impaired Symbol Digit Modalities Test (SDMT)
timeFrame: Baseline up to Week 96
measure: Percent Change From Baseline in Brain Volume
timeFrame: Baseline up 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: Carlsbad
country: United States
facility: TG Therapeutics RMS Investigational Trial Site
state: California
city: Long Beach
country: United States
facility: TG Therapeutics RMS Investigational Trial Site
state: California
city: Pasadena
country: United States
facility: TG Therapeutics RMS Investigational Trial Site
state: California
city: Stanford
country: United States
facility: TG Therapeutics RMS Investigational Trial Site
state: California
city: Miami
country: United States
facility: TG Therapeutics RMS Investigational Trial Site
state: Florida
city: Northbrook
country: United States
facility: TG Therapeutics RMS Investigational Trial Site
state: Illinois
city: Kansas City
country: United States
facility: TG Therapeutics RMS Investigational Trial Site
state: Kansas
city: Detroit
country: United States
facility: TG Therapeutics RMS Investigational Trial Site
state: Michigan
city: Amherst
country: United States
facility: TG Therapeutics RMS Investigational Trial Site
state: New York
city: Westerville
country: United States
facility: TG Therapeutics RMS Investigational Trial Site
state: Ohio
city: Franklin
country: United States
facility: TG Therapeutics RMS Investigational Trial Site
state: Tennessee
city: Knoxville
country: United States
facility: TG Therapeutics RMS Investigational Trial Site
state: Tennessee
city: Dallas
country: United States
facility: TG Therapeutics RMS Investigational Trial Site
state: Texas
city: Round Rock
country: United States
facility: TG Therapeutics RMS Investigational Site
state: Texas
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.