BridgeMD
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial of Descartes-08 in Patients With Generalized Myasthenia Gravis (MG)
EU CTIS ID: 2024-520355-25-00
What this study is testing
To evaluate the efficacy of Descartes-08 as assessed by the proportion of Myasthenia Gravis Activities of Daily Living (MG-ADL) responders at Month 4.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patient must be at least 18 years of age.
- Patient must have gMG, MGFA clinical classification grades II-IV at Screening.
- MG-Activities of Daily Living (MG ADL) total score ≥ 6
- Concomitant immunosuppressive drugs must be deemed necessary by the Investigator. The patient must be on a stable dose for a minimum of 8 weeks prior to Baseline visit.
- If a patient is using corticosteroids, the daily dose should not exceed 40 mg/day of prednisone (or equivalent). The dose must be stable for a minimum of 8 weeks prior to Baseline visit.
- Acetylcholine receptor autoantibody (anti-nAChR) titer or anti-AChR cluster antibody must be above the reference laboratory upper normal limit (UNL) and documented within the past 10 years of Screening.
You likely can't join if
- Major chronic illness that is not well managed at the time of study entry and in the opinion of the Investigator, may increase the safety risk to the patient.
- Abnormal PT/INR or PTT increased > 1.5-fold above the normal range at Screening or the patient is on anticoagulation therapy (except in cases of elevated PTT with documented lupus anticoagulant; or in patients who have been on stable doses of anticoagulation therapy for more than 6 months of VTE diagnosis; or in patients on stable doses of anticoagulation therapy for at least 8 weeks of atrial fibrillation diagnosis; these conditions will not be exclusionary unless, in the investigator’s opinion, they make participation in the study unsafe).
- ANC < 1000 cells/microliter
- Hemoglobin < 8.0 g/dL
- Platelets: < 50,000/mm at screening
- Creatinine Clearance < 30 mL/min at Screening
See the full eligibility criteria
- Patient must be at least 18 years of age.
- Patient must have gMG, MGFA clinical classification grades II-IV at Screening.
- MG-Activities of Daily Living (MG ADL) total score ≥ 6
- Concomitant immunosuppressive drugs must be deemed necessary by the Investigator. The patient must be on a stable dose for a minimum of 8 weeks prior to Baseline visit.
- If a patient is using corticosteroids, the daily dose should not exceed 40 mg/day of prednisone (or equivalent). The dose must be stable for a minimum of 8 weeks prior to Baseline visit.
- Acetylcholine receptor autoantibody (anti-nAChR) titer or anti-AChR cluster antibody must be above the reference laboratory upper normal limit (UNL) and documented within the past 10 years of Screening.
- Patient must be willing to return for all study visits.
- Patient must be able to provide written informed consent.
- Women of childbearing potential must agree to use highly effective birth control from Screening until 14 days post last dose of Descartes-08.
- Major chronic illness that is not well managed at the time of study entry and in the opinion of the Investigator, may increase the safety risk to the patient.
- Abnormal PT/INR or PTT increased > 1.5-fold above the normal range at Screening or the patient is on anticoagulation therapy (except in cases of elevated PTT with documented lupus anticoagulant; or in patients who have been on stable doses of anticoagulation therapy for more than 6 months of VTE diagnosis; or in patients on stable doses of anticoagulation therapy for at least 8 weeks of atrial fibrillation diagnosis; these conditions will not be exclusionary unless, in the investigator’s opinion, they make participation in the study unsafe).
- ANC < 1000 cells/microliter
- Hemoglobin < 8.0 g/dL
- Platelets: < 50,000/mm at screening
- Creatinine Clearance < 30 mL/min at Screening
- History of primary immunodeficiency, organ, or allogeneic bone marrow transplant
- Diagnosis of gMG within 12 months of Screening.
- No history of systemic treatment for gMG other than acetylcholine esterase inhibitors.
- Diagnosis of a neuromuscular disease other than gMG.
- Patient is pregnant or lactating.
- Treatment with IVIG or plasma exchange within 4 weeks prior to the Baseline visit.
- Ongoing treatment with rituximab/ocreluzimab or calcineurin inhibitors, e.g., tacrolimus, cyclosporine or cyclophosphamide or Neonatal Fc receptor antagonists, e.g. efgartigimod.
- The patient has started treatment with a complement 5a (C5a) inhibitor, such as eculizumab, within 8 weeks prior to the Baseline visit.
- Prior treatment with BCMA-directed therapy (e.g. monoclonal antibody, T-cell engager, or CAR-T).
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- United Kingdom
- Turkey
- United States
- Serbia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; United Kingdom; Turkey; United States; Serbia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.