Phase III: UbLiTuximab In Multiple Sclerosis Treatment Effects (ULTIMATE I STUDY)
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- TG Therapeutics, Inc.
- Enrollment
- 549
- Locations
- 2
- Primary Endpoint
- Annualized Relapse Rate (ARR)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Double-blinded, active-controlled study
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Ublituximab + Oral Placebo
Participants were administered ublituximab 150 milligrams (mg), intravenous (IV) infusion over 4 hours (h) on Day 1 followed by 450 mg over 1 h on Days 15, 168, 336 and 504 (Week 72) along with the oral placebo once daily (QD) from Day 1 up to the last day of Week 95.
Intervention: Ublituximab (Biological)
Ublituximab + Oral Placebo
Participants were administered ublituximab 150 milligrams (mg), intravenous (IV) infusion over 4 hours (h) on Day 1 followed by 450 mg over 1 h on Days 15, 168, 336 and 504 (Week 72) along with the oral placebo once daily (QD) from Day 1 up to the last day of Week 95.
Intervention: Oral Placebo (Drug)
Teriflunomide + IV Placebo
Participants were administered teriflunomide 14 mg tablet, orally, QD from Day 1 up to the last day of Week 95 along with the placebo IV infusion on Days 1, 15, 168, 336 and 504 (Week 72).
Intervention: Teriflunomide (Drug)
Teriflunomide + IV Placebo
Participants were administered teriflunomide 14 mg tablet, orally, QD from Day 1 up to the last day of Week 95 along with the placebo IV infusion on Days 1, 15, 168, 336 and 504 (Week 72).
Intervention: IV Placebo (Drug)
Outcomes
Primary Outcomes
Annualized Relapse Rate (ARR)
Time Frame: Up to 96 weeks
ARR is defined as the number of Independent Relapse Adjudication Panel (IRAP)-confirmed relapses per participant year. The estimate of ARR for a treatment group is the total number of relapses for participants in the respective treatment group divided by the sum of treatment duration for participants in that specific treatment group.
Secondary Outcomes
- Total Number of New and Enlarging T2 Hyperintense Lesions (NELs) Per MRI Scan Per Participant(Weeks 24, 48, and 96)
- Time to Confirmed Disability Progression (CDP) for at Least 12 Weeks(Up to Week 96)
- Total Number of Gadolinium (Gd)-Enhancing T1-Lesions Per Magnetic Resonance Imaging (MRI) Scan Per Participant(Weeks 12, 24, 48, and 96)
- Percentage of Participants With No Evidence of Disease Activity (NEDA)(Week 24 up to Week 96)
- Percentage of Participants With Impaired Symbol Digit Modalities Test (SDMT)(Baseline up to Week 96)
- Percent Change From Baseline in Brain Volume(Baseline up to Week 96)
- Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)(From the first dose of study drug through the end of the study (up to approximately 116 weeks))