Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS) (ULTIMATE II)

TG Therapeutics

Status and phase: Completed; Phase 3

Conditions: Relapsing Multiple Sclerosis (RMS)

Treatments: Drug: Teriflunomide; Drug: Oral Placebo; Drug: IV Placebo; Biological: Ublituximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03277248

TG1101-RMS302

2017-000639-15 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 545 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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545 participants in 2 patient groups

Ublituximab + Oral Placebo

Experimental group

Description:

Participants received ublituximab intravenous (IV) infusion, 150 milligrams (mg) 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 tablet, once daily (QD) from Day 1 up to the last day of Week 95.

Treatment:

Biological: Ublituximab

Drug: Oral Placebo

Teriflunomide + IV Placebo

Active Comparator group

Description:

Participants received 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).

Treatment:

Drug: IV Placebo

Drug: Teriflunomide