CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 549 enrolled
Drug / intervention
Ublituximab +3 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03277261
NCT03277261Phase 3Completed
CompareCT.gov

Phase III: UbLiTuximab In Multiple Sclerosis Treatment Effects (ULTIMATE I STUDY)

TG Therapeutics, Inc.·interventional·Posted Sep 11, 2017·Updated Dec 6, 2021

In Brief

A Phase 3 clinical trial evaluating Ublituximab, Teriflunomide, and 2 other interventions for Relapsing Multiple Sclerosis (RMS). Completed, enrolled 549 participants across 14 sites.

Detailed 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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRelapsing Multiple Sclerosis (RMS)
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedSep 11, 2017
Enrollment StartSep 19, 2017
Primary CompletionJul 23, 2020
Study CompletionNov 6, 2020
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 8.8 years ago

Interventions

Ublituximabbiological

Administered as an IV infusion.

Teriflunomidedrug

Film-coated tablets administered orally.

Oral Placebodrug

Administered orally.

IV Placebodrug

Administered as an IV infusion.