Trials / Completed
CompletedNCT03277261
Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS) ( ULTIMATE 1 )
Phase III: UbLiTuximab In Multiple Sclerosis Treatment Effects (ULTIMATE I STUDY)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 549 (actual)
- Sponsor
- TG Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Ublituximab | Administered as an IV infusion. |
| DRUG | Teriflunomide | Film-coated tablets administered orally. |
| DRUG | Oral Placebo | Administered orally. |
| DRUG | IV Placebo | Administered as an IV infusion. |
Timeline
- Start date
- 2017-09-19
- Primary completion
- 2020-07-23
- Completion
- 2020-11-06
- First posted
- 2017-09-11
- Last updated
- 2021-12-06
- Results posted
- 2021-12-06
Locations
14 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03277261. Inclusion in this directory is not an endorsement.