Myasthenia GravisPhase 2NCT07673744
A Study to Evaluate the Efficacy and Safety of Maintenance Ublituximab Following Induction With Efgartigimod Administration in Participants With Myasthenia Gravis (MG)
A Phase 2 study testing Ublituximab in people with Myasthenia Gravis, run by TG Therapeutics, Inc. at 7 sites in United States.
Trial summary
The primary purpose of this study is to evaluate the efficacy of ublituximab in adult participants with MG responding to treatment with efgartigimod. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myasthenia Gravis
- What is being tested?
- Ublituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 7 sitesUnited States
- Study dates
- 1 Nov 2026to 1 Jan 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documentation of MG diagnosis.
- Eligible for treatment with efgartigimod per effective local product label, confirmed by serological testing at screening.
- MG-ADL score at the time of screening more than or equal to (≥) 6 and less than or equal to (≤) 10 with more than (>) 50 percent (%) of this score attributed to non-ocular items, or an MG-ADL score ≥ 11.
Who cannot join
- Active chronic (or stable but treated with immune therapy) disease of the immune system other than MG (e.g., rheumatoid arthritis, scleroderma, Sjögren's syndrome, Crohn's disease, ulcerative colitis, etc.) or immunodeficiency syndrome (hereditary immune deficiency, drug-induced immune deficiency, etc.).
- Lack of efficacy or observed safety concerns from prior neonatal Fc receptor (FcRn) treatment.
- Prior treatment with B-cell depleting therapy, alemtuzumab, total lymphoid irradiation, bone marrow transplant, T-cell vaccination therapy, or natalizumab at any time prior to screening.
- Participants with significantly impaired organ function.
- History of life-threatening injection/infusion related reaction (IRR/ISR), hypersensitivity, or anaphylactic reaction with components of efgartigimod or ublituximab solutions, protocol-allowed rescue medications, or protocol required pre-treatment medications.
- Unwillingness or inability to comply with study and/or follow-up procedures outlined in the protocol.
- Note: Other protocol-specified Inclusion/Exclusion criteria may apply.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
TG Therapeutics Investigational Trial Site
Clearwater, Florida, 33761
- Recruiting
TG Therapeutics Investigational Trial Site
Colorado Springs, Colorado, 80919
- Recruiting
TG Therapeutics Investigational Trial Site
Colorado Springs, Colorado, 80920
- Recruiting
TG Therapeutics Investigational Trial Site
Farmington Hills, Michigan, 48334
- Recruiting
TG Therapeutics Investigational Trial Site
Greenville, South Carolina, 29605
- Recruiting
TG Therapeutics Investigational Trial Site
Maitland, Florida, 32751
- Recruiting
TG Therapeutics Investigational Trial Site
New Bern, North Carolina, 28562
About this study
Official title: A Phase 2, Randomized, Double-blind, Multicenter, Placebo-controlled Study to Evaluate the Efficacy and Safety of Maintenance Ublituximab Treatment Following Induction With Efgartigimod Administration in Adults With Myasthenia Gravis
The primary purpose of this study is to evaluate the efficacy of ublituximab in adult participants with MG responding to treatment with efgartigimod.
- Conditions
- Myasthenia Gravis
- Being tested
- Ublituximab, Placebo
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UblituximabDrug
Also called BRIUMVI
Administered as an IV infusion.
PlaceboDrug
Administered as an IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| Randomized controlled period (RCP) | Experimental | Responder participants from efgartigimod induction period will be randomised 1:1 ratio to receive either ublituximab or ublituximab matching-placebo intravenous (IV) infusion. Receives: Drug: Ublituximab; Drug: Placebo |
| Open-label period (OLP): Ublituximab | Experimental | Non-responder participants from efgartigimod induction period will receive ublituximab IV infusion. Receives: Drug: Ublituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Onset of a Clinical Worsening Event
Measured: Up to Week 24
Secondary outcomes (4)
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Measured: Up to Week 72
Maximum Plasma Concentration (Cmax) of Ublituximab
Measured: Up to Week 72
Proportion of Participants with Cluster of Differentiation 19 + (CD19+) B-cell Counts
Measured: Up to Week 72
Change From Baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Total Score in RCP
The MG-ADL scale focuses on relevant symptoms and functional performance of activities of daily living in participants with MG. The total score varies between 0-24, with higher score indicating more severe disease.
Measured: Baseline, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myasthenia GravisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TG Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07673744
- Sponsor's protocol ID
- TG1101-MG201
- Other IDs
- 2025-524630-26-00, 2025
- Status last verified
- Oct 2026
- First submitted
- 10 Jun 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-blind, Multicenter, Placebo-controlled Study to Evaluate the Efficacy and Safety of Maintenance Ublituximab Treatment Following Induction With Efgartigimod Administration in Adults With Myasthenia Gravis
- ClinicalTrials.gov ID
- NCT07673744
- Acronym / sponsor ID
- TG1101-MG201
- Conditions
- Myasthenia Gravis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- TG Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 29 Jun 2026 (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.
The primary purpose of this study is to evaluate the efficacy of ublituximab in adult participants with MG responding to treatment with efgartigimod.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Randomized controlled period (RCP) | Experimental | Drug: Ublituximab, Drug: PlaceboResponder participants from efgartigimod induction period will be randomised 1:1 ratio to receive either ublituximab or ublituximab matching-placebo intravenous (IV) infusion. |
| Open-label period (OLP): Ublituximab | Experimental | Drug: UblituximabNon-responder participants from efgartigimod induction period will receive ublituximab IV infusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Documentation of MG diagnosis.
- Eligible for treatment with efgartigimod per effective local product label, confirmed by serological testing at screening.
- MG-ADL score at the time of screening more than or equal to (≥) 6 and less than or equal to (≤) 10 with more than (>) 50 percent (%) of this score attributed to non-ocular items, or an MG-ADL score ≥ 11.
Key exclusion criteria (7 listed)
- Active chronic (or stable but treated with immune therapy) disease of the immune system other than MG (e.g., rheumatoid arthritis, scleroderma, Sjögren's syndrome, Crohn's disease, ulcerative colitis, etc.) or immunodeficiency syndrome (hereditary immune deficiency, drug-induced immune deficiency, etc.).
- Lack of efficacy or observed safety concerns from prior neonatal Fc receptor (FcRn) treatment.
- Prior treatment with B-cell depleting therapy, alemtuzumab, total lymphoid irradiation, bone marrow transplant, T-cell vaccination therapy, or natalizumab at any time prior to screening.
- Participants with significantly impaired organ function.
- History of life-threatening injection/infusion related reaction (IRR/ISR), hypersensitivity, or anaphylactic reaction with components of efgartigimod or ublituximab solutions, protocol-allowed rescue medications, or protocol required pre-treatment medications.
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: BRIUMVIAdministered as an IV infusion. | Drug | Open-label period (OLP): Ublituximab, Randomized controlled period (RCP) |
| PlaceboAdministered as an IV infusion. | Drug | Randomized controlled period (RCP) |
Primary outcome
Time to Onset of a Clinical Worsening Event
Time frame: Up to Week 24
4 secondary outcomes
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to Week 72
Maximum Plasma Concentration (Cmax) of Ublituximab
Time frame: Up to Week 72
Proportion of Participants with Cluster of Differentiation 19 + (CD19+) B-cell Counts
Time frame: Up to Week 72
Change From Baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Total Score in RCP
Time frame: Baseline, Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
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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.
7 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 Myasthenia Gravis, run by TG Therapeutics, Inc. at 7 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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact TG Therapeutics Clinical Support Team (1-877-575-8489, clinicalsupport@tgtxinc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Onset of a Clinical Worsening Event (time frame: Up to Week 24). 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 29 Oct 2026.