Actively Recruiting Myasthenia Gravis Clinical Trials

Key Takeaways:

• The treatment landscape for myasthenia gravis is rapidly evolving, with many ongoing clinical trials investigating novel therapeutic approaches to improve patient outcomes and reduce the burden of this condition.
• Several actively recruiting clinical trials are underway for generalized and ocular myasthenia gravis (MG), exploring novel therapeutic approaches such as complement inhibitors, FcRn antagonists, and cell-based therapies.

Several clinical trials are currently enrolling participants with generalized myasthenia gravis (gMG) and ocular myasthenia gravis (OMG), exploring various mechanisms of action. These include studies evaluating new complement inhibitors, FcRn antagonists, and cell-based therapies. These trials often use certain MG clinical scales and clinical assessments such as the MGFA class, MG-ADL patient-reported assessment, and the QMG physician-reported assessment in evaluating MG patients.¹

Telitacicept for generalized myasthenia gravis (RemeMG Study)

The RemeMG study is a Phase 3, randomized, double-blind, placebo-controlled study currently recruiting patients. The global study has reported positive results, reporting a sustained and significant improvement in outcomes for patients with gMG.^1,2

• Objective – Evaluate the efficacy and safety of telitacicept, a TACI-Fc fusion protein that inhibits B cell maturation and proliferation, in adults with gMG.
• Inclusion criteria – Adults 18 years and older with acetylcholine receptor antibody (AChR)-positive or muscle-specific kinase (MuSK)-positive gMG, MGFA Class 2-4, MG-ADL score ≥6, and QMG score ≥ 6. Additional inclusion criteria apply.
• Exclusion criteria – Patients who have been diagnosed with another autoimmune disease, have an acute or chronic infection, have thymoma within 5 years, or have received a thymectomy within the past 6 months. Additional exclusion criteria apply.
• Contact – Refer to the ClinicalTrials.gov identifier NCT06456580 for study sites and contact information.

DNTH103 for generalized myasthenia gravis (MaGic Study)

The MaGic study is a global, randomized, double-blind, placebo-controlled study currently in Phase 2.^1,3,4

• Objective – Evaluate the efficacy and safety of DNTH103, a potent classical complement inhibitor, in adults with gMG
• Inclusion criteria – Adults aged 18 to 75 years with a confirmed diagnosis of AChR-positive gMG, MGFA Class 2-4a, and an MG-ADL score of ≥ 6. Additional inclusion criteria apply.
• Exclusion criteria – Prior history of Neisseria meningitidis infection; active HIV, Hepatitis B, or Hepatitis C infection; thymic surgery within 1 year; thymoma; or use of rituximab within 6 months or IVIg/PLEX within 4 weeks before randomization. Additional exclusion criteria apply.
• Contact – Refer to the ClinicalTrials.gov identifier NCT06282159 for study sites and contact information.

CABA-201 CAR T-cell therapy for generalized myasthenia gravis (RESET-MG™ Study)

The RESET-MG study is a Phase 1/2 multi-center, open-label study.^1,5

• Objective – Evaluate the safety and efficacy of CABA-201, an investigational anti-CD19 CAR T-cell therapy, in patients with gMG
• Inclusion criteria – Adults aged 18 to 70 years with a diagnosis of AChR-positive, MuSK-positive, LRP4-positive, or seronegative gMG (MGFA 2-4b). Additional inclusion criteria apply.
• Exclusion criteria – Active infections, clinical significant medical conditions, or organ impairment, or prior organ transplant. Other exclusion criteria apply.
• Contact – Refer to the ClinicalTrials.gov identifier NCT06282159 for study sites and contact information.

Remibrutinib for generalized myasthenia gravis (RELIEVE)

The RELIEVE study is a Phase III multi-center, double-blind, placebo-controlled study.^1,6

• Objective – Evaluate the efficacy, safety, and tolerability of remibrutinib versus placebo in adult patients with gMG who are on stable, standard-of-care (SOC) treatment
• Inclusion criteria – Adult patients aged 18 to 75 years with a confirmed diagnosis of AChR-positive, MuSK-positive, or seronegative gMG, MGFA Class 2-4, and a baseline MG-ADL score ≥ 6. Additional inclusion criteria apply.
• Exclusion criteria – Patients who have been treated with intravenous immunoglobulins or plasma exchange in the past month, with rituximab in the past 6 months, eculizumab in the past 2 months, ravulizumab or other complement inhibitors in the past 3 months, efgartigimod or other anti-FcRn therapies in the past 3 months, or had a thymectomy in the past 6 months or a planned thymectomy during the trial period. Additional exclusion criteria apply.
• Contact – Refer to the ClinicalTrials.gov identifier NCT06744920 for study sites and contact information.

YTB323 for treatment-resistant generalized myasthenia gravis

This is a Phase 1/2 open-label, multicenter study.^1,7

• Objective – Assess the safety, efficacy, and cellular kinetics of YTB323, an investigational anti-CD19 CAR-T cell therapy, in patients with treatment-resistant gMG
• Inclusion criteria – Adults 18-65 years old with a confirmed diagnosis of AChR-positive or MuSK-positive gMG, MGFA class 3-4a, MG-ADL score ≥ 6, who have had an inadequate response to at least 2 conventional immunosuppressive treatment. Additional inclusion criteria apply.
• Exclusion criteria – Clinical significant active or chronic infection, known immunodeficiency syndrome, positive HIV testing, history of bone marrow/hematopoietic stem cell or solid organ transplant, or prior treatment with anti-CD19 therapy, adoptive T-cell therapy, or any prior gene therapy. Additional exclusion criteria apply.
• Contact – Refer to the ClinicalTrials.gov identifier NCT06704269 for study sites and contact information.

These are not the only clinical trials for MG

These are not the only ongoing, actively recruiting trials in myasthenia gravis (MG). You can find information about other ongoing trials at ClinicalTrials.gov and under Clinical Trial Opportunities on the Myasthenia Gravis Foundation of America website.

The ongoing clinical trial landscape in myasthenia gravis offers hope for the development of more targeted and effective therapies. Healthcare providers are encouraged to stay informed about these trials and consider referring eligible patients.

Detailed information regarding inclusion/exclusion criteria and contact information for these and other MG trials is available on ClinicalTrials.gov or by contacting the listed sponsors directly. By participating in these studies, patients can contribute to advancing the understanding and treatment of this challenging neuromuscular disorder.