Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS) ( ULTIMATE 1 )

TG Therapeutics

Status and phase: Completed; Phase 3

Conditions: Relapsing Multiple Sclerosis (RMS)

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT03277261

TG1101-RMS301

2017-000638-75 (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: 549 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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549 participants in 2 patient groups

Ublituximab + Oral Placebo

Experimental group

Description:

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.

Treatment:

Drug: Oral Placebo

Biological: Ublituximab

Teriflunomide + IV Placebo

Active Comparator group

Description:

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).

Treatment:

Drug: Teriflunomide

Drug: IV Placebo