Relapsing Remitting Multiple SclerosisPhase 2NCT03381170
An Extension of the TG1101-RMS201 Trial
A Phase 2 study testing Ublituximab in people with Relapsing Remitting Multiple Sclerosis, run by TG Therapeutics, Inc. at 8 sites in United States.
Trial summary
This study evaluates the long term use of a single agent ublituximab, a novel monoclonal antibody, in patients with relapsing forms of multiple sclerosis Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis
- What is being tested?
- Ublituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 8 sitesUnited States
- Study dates
- 1 Jun 2017to 11 Nov 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects currently enrolled in TG1101-RMS201 trial
- Subjects who have completed three infusions of ublituximab (at Day 1, Day 15, and Week24, as specified in the TG1101-RMS201 protocol) and have completed the scheduled assessments up to the final 48-week visit
Who cannot join
- Subjects who discontinued ublituximab treatment or withdrew consent from the TG1101- RMS201 study during the 48-week evaluation period
- Subjects who have started any other immunomodulating or disease modifying therapy after completion of the TG1101-RMS201 trial
- Pregnant or nursing mothers
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
TG Therapeutics Investigational Trial Site
Aurora, Colorado, 80045
TG Therapeutics Investigational Trial Site
Columbus, Ohio, 43210
TG Therapeutics Investigational Trial Site
Knoxville, Tennessee, 37922
TG Therapeutics Investigational Trial Site
Lexington, Kentucky, 40513
TG Therapeutics Investigational Trial Site
Pasadena, California, 91105
TG Therapeutics Investigational Trial Site
Round Rock, Texas, 78681
TG Therapeutics Investigational Trial Site
San Antonio, Texas, 78258
TG Therapeutics Investigational Trial Site
Westerville, Ohio, 43081
About this study
Official title: An Open Label Extension of the TG1101-RMS201 Trial, for Subjects Currently Enrolled in TG1101-RMS201Treated With Ublituximab for Relapsing Forms of Multiple Sclerosis
This study evaluates the long term use of a single agent ublituximab, a novel monoclonal antibody, in patients with relapsing forms of multiple sclerosis
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Being tested
- Ublituximab
- Keywords
- Relapsing Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UblituximabBiological
Also called TG1101
Enrolled Subjects will be infused with ublituximab on Weeks 1E, 24E, 48E, 72E and 96E
| Study group | Role | What they receive |
|---|---|---|
| Ublituximab | Experimental | Ublituximab IV infusions on Weeks 1E, 24E, 48E, 72E and (6E Receives: Biological: Ublituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related events as assessed by CTCAE V4.0
to determine the incidence of adverse events and any abnormal laboratory values
Measured: 96 weeks on therapy
Secondary outcomes (1)
Evaluate the % of participants with relapses
Measured: up to 96 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2017
- Study start1 Jun 2017
- Primary completion11 Nov 2022
- Study completion11 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing Remitting Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by TG Therapeutics, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- TG Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03381170
- Sponsor's protocol ID
- TG1101-RMS201E
- Status last verified
- Dec 2022
- First submitted
- 18 Dec 2017
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be shared after study completion via publication
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Extension of the TG1101-RMS201 Trial, for Subjects Currently Enrolled in TG1101-RMS201Treated With Ublituximab for Relapsing Forms of Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03381170
- Acronym / sponsor ID
- TG1101-RMS201E
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Keywords
- Relapsing Multiple Sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- TG Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 11 Nov 2022 (actual)
- Study completion
- 11 Nov 2022 (actual)
- First posted
- 21 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the long term use of a single agent ublituximab, a novel monoclonal antibody, in patients with relapsing forms of multiple sclerosis
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ublituximab | Experimental | Biological: UblituximabUblituximab IV infusions on Weeks 1E, 24E, 48E, 72E and (6E |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Subjects currently enrolled in TG1101-RMS201 trial
- Subjects who have completed three infusions of ublituximab (at Day 1, Day 15, and Week24, as specified in the TG1101-RMS201 protocol) and have completed the scheduled assessments up to the final 48-week visit
Key exclusion criteria (3 listed)
- Subjects who discontinued ublituximab treatment or withdrew consent from the TG1101- RMS201 study during the 48-week evaluation period
- Subjects who have started any other immunomodulating or disease modifying therapy after completion of the TG1101-RMS201 trial
- Pregnant or nursing mothers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UblituximabAlso: TG1101Enrolled Subjects will be infused with ublituximab on Weeks 1E, 24E, 48E, 72E and 96E | Biological | Ublituximab |
Primary outcome
Number of participants with treatment-related events as assessed by CTCAE V4.0
Time frame: 96 weeks on therapy
to determine the incidence of adverse events and any abnormal laboratory values
1 secondary outcome
Evaluate the % of participants with relapses
Time frame: up to 96 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
- Individual participant dataSharing planned: Undecided. Data will be shared after study completion via publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ublituximab in people with Relapsing Remitting Multiple Sclerosis, run by TG Therapeutics, Inc. at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related events as assessed by CTCAE V4.0 (time frame: 96 weeks on therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2022.