Phase IIa Study of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis

TG Therapeutics

Status and phase: Completed; Phase 2

Conditions: Multiple Sclerosis

Treatments: Biological: Ublituximab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02738775

TG1101-RMS-201

Details and patient eligibility

About

This study evaluates the use of single agent ublituximab, a novel monoclonal antibody, in participants with relapsing forms of multiple sclerosis.

Enrollment: 49 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of relapsing multiple sclerosis
• Active disease
• Greater than or equal to (≥) 2 relapses in prior 2 years or 1 relapse in the year prior to screening and/or ≥1 gadolinium (Gd) enhancing lesion

Exclusion criteria

• Treatment with anti-cluster of differentiation 20 (CD20) monoclonal antibody within the last 12 months
• Treatment with alemtuzumab within the last 12 months
• Pregnant or nursing mothers

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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49 participants in 6 patient groups

Cohort 1

Experimental group

Description:

Participant received intravenous (IV) infusion of ublituximab 150 milligrams (mg)/4 hour (hr) on Day 1, 450 mg/3 hr on Day 15 and 450 mg/1.5 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /3 hr on Day 15 before receiving ublituximab.

Treatment:

Drug: Placebo

Biological: Ublituximab

Cohort 2

Experimental group

Description:

Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1.5 hr on Day 15 and 450 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1.5 hr on Day 15 before receiving ublituximab.

Treatment:

Drug: Placebo

Biological: Ublituximab

Cohort 3

Experimental group

Description:

Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.

Treatment:

Drug: Placebo

Biological: Ublituximab

Cohort 4

Experimental group

Description:

Participant received IV infusion of ublituximab 150 mg/3 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /3 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.

Treatment:

Drug: Placebo

Biological: Ublituximab

Cohort 5

Experimental group

Description:

Participant received IV infusion of ublituximab 150 mg/2 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /2 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.

Treatment:

Drug: Placebo

Biological: Ublituximab

Cohort 6

Experimental group

Description:

Participant received IV infusion of ublituximab 150 mg/1 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /1 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.

Treatment:

Drug: Placebo

Biological: Ublituximab