Phase 2 Study of Ublituximab in Patients With Relapsing Forms of Multiple Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02738775
• Date of registration: 10/04/2016
• Prospective Registration: No
• Primary sponsor: TG Therapeutics, Inc.
• Public title: Phase 2 Study of Ublituximab in Patients With Relapsing Forms of Multiple Sclerosis
• Scientific title: A Placebo-Controlled Multi-Center Phase 2 Study of Ublituximab, a Third-Generation Anti-CD20 Monoclonal Antibody, in Patients With Relapsing Forms of Multiple Sclerosis.
• Date of first enrolment: March 18, 2016
• Target sample size: 48
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02738775
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Care Provider).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Edward Fox, MD, PhD
• Affiliation: Central Texas Neurology

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosis of relapsed multiple sclerosis

- Active disease

- Greater than 1 relapse in prior 2 years

Exclusion Criteria:

- Treatment with anti-CD20 monoclonal antibody within the last 12 months

- Treatment with alemtuzumab within the last 12 months

- Pregnant or nursing mothers



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: Placebo

Biological: Ublituximab

Primary Outcome(s)

B-cell depletion [Time Frame: Day 28]

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [Time Frame: 6 months on therapy]

Secondary Outcome(s)

Evaluate the % of relapses in relapsed multiple sclerosis patients [Time Frame: up to 48 weeks]

Secondary ID(s)

TG1101-RMS-201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors