Study to Evaluate Safety, Efficacy and Pharmacokinetics (PK) of a Modified Regimen of Ublituximab

Conditions

• Relapsing Multiple Sclerosis

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Ublituximab — BIOLOGICAL
  Administered as an intravenous (IV) infusion.
• Placebo — DRUG
  IV infusion

Study Details

The primary purpose of this phase 3b study is to assess the efficacy of a modified regimen of ublituximab in participants with relapsing multiple sclerosis (RMS) as measured by T1 Gadolinium (Gd)-enhancing lesions in Part A; PK in Part B along with efficacy of ublituximab as measured by T1 Gd-enhancing lesions in participants who had a suboptimal experience on prior anti-CD20 therapy in Part C. The study consists of 3 parts: Part A is single-armed and open-label, Part B is randomized, double-blind, placebo-controlled, and Part C is single-armed and open-label.

Key Dates

Start date

Jun 13, 2023

Status verified

May 2026

Primary completion

Dec 1, 2027

Completion

Dec 1, 2027

Study Design

Enrollment

800 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Part A: Ublituximab
  Participants will receive a modified regimen of ublituximab including infusions on Day 1 of Week 1 (W1D1), Day 15, if applicable, and ublituximab 450 milligrams (mg) infusion at Week 24. With Protocol Version 6.0, enrollment in Part A was closed.
• Experimental: Part B: Ublituximab /Placebo (Treatment Arm A)
  Participants will receive 600 mg of ublituximab on W1D1 followed by a placebo infusion on Day 15 and 450 mg ublituximab infusion at Week 24. With Protocol Version 7.0, enrollment in Part B will be closed.
• Experimental: Part B: Ublituximab (Treatment Arm B)
  Participants will receive 150 mg of ublituximab on W1D1 followed by 450 mg on Day 15 and at Week 24. With Protocol Version 7.0, enrollment in Part B will be closed.
• Experimental: Part C: Ublituximab (Treatment Arm C)
  Participants will receive 150 mg of ublituximab on W1D1, followed by 450 mg on Day 15 and at Week 24.

Primary Outcome Measure

Part A and Part C: Percentage of Participants With no Change or Reduction in Number of T1 Gd-Enhancing Lesions From Baseline to Week 48 [ Time Frame: Baseline up to Week 48 ]

Central Contacts

• TG Therapeutics Clinical Support Team
  1-877-575-8489
  [email protected]

Locations (36)

Find similar trials in Birmingham, AL

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