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

Conditions

• Relapsing Multiple Sclerosis (RMS)

Eligibility Criteria

Sex

ALL

Age

18 Years - 55 Years

Healthy Volunteers

Not accepted

Interventions

• Ublituximab — BIOLOGICAL
  Administered as an IV infusion.
• Teriflunomide — DRUG
  Film-coated tablets administered orally.
• Oral Placebo — DRUG
  Administered orally.
• IV Placebo — DRUG
  Administered as an IV infusion.

Study Details

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.

Key Dates

Start date

Sep 19, 2017

Status verified

Nov 2021

Primary completion

Jul 23, 2020

Completion

Nov 6, 2020

Study Design

Enrollment

549 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 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.
• Active Comparator: 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).

Primary Outcome Measure

Annualized Relapse Rate (ARR) [ Time Frame: Up to 96 weeks ]

Locations (14)

Find similar trials in Carlsbad, CA