EUCTR2019-003383-47-IT
Active, not recruiting
Phase 1
A Phase 2, Randomized, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Efficacy of TAK-079 in Patients With Generalized Myasthenia Gravis -
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Generalized Myasthenia Gravis
- Sponsor
- MILLENNIUM PHARMACEUTICALS, INC.
- Enrollment
- 36
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Each patient must meet all the following inclusion criteria to be randomized to treatment:
- •1\. The patient understands and agrees to study participation by providing a signed and dated written informed consent form (ICF) and any required privacy authorization before the initiation of any study procedures (as applicable, the patient’s legally acceptable representative may provide written informed consent in accordance with local and regional regulatory requirements) and, in the opinion of the investigator, is capable of complying with protocol requirements.
- •2\. Aged 18 years or older.
- •3\. Diagnosis of MG supported by a positive serologic test for anti\-AChR or anti\-MuSK antibodies at screening.
- •4\. MGFA clinical classification class II to IV at screening.
- •5\. MG\-ADL total score of 6 or greater at screening, with at least 4 points of this score attributed to nonocular items.
- •6\. If receiving immunosuppressive drugs (ie, mycophenolate mofetil, methotrexate, cyclosporine, tacrolimus, cyclophosphamide), therapy must be ongoing for at least 6 months, with a stable dosing ongoing for at least 3 months before screening. Patients receiving azathioprine must be on a stable dose for at least 6 months before screening.
- •7\. If receiving oral corticosteroids, therapy must be ongoing for at least 3 months, with a stable dose at least 1 month before screening. Corticosteroids, including dexamethasone, must be given as oral, daily or every\-other\-day therapy, as opposed to pulse therapy.
- •8\. If receiving cholinesterase inhibitors, therapy with a stable dose is required at least 2 weeks before screening.
- •9\. The doses of concomitant standard background therapy must be expected to remain stable throughout the study unless dose reduction is required due to toxicities. Allowed background therapy is defined as no more than a cholinesterase inhibitor ± corticosteroid ± one steroid\-sparing immunosuppressive drug (limited to azathioprine, mycophenolate mofetil, methotrexate, cyclosporine, tacrolimus, or cyclophosphamide). Patients must be on at least one allowed background medication.
Exclusion Criteria
- •Patients meeting any of the following exclusion criteria are not to be randomized to treatment:
- •1\. History of thymoma or other thymic neoplasms.
- •2\. History of thymectomy within 12 months before screening.
- •3\. MGFA class I or V.
- •4\. Received IVIg, SCIg (subcutaneous immunoglobulin), or plasmapheresis/plasma exchange within 4 weeks before screening.
- •5\. Chronic obstructive pulmonary disease (COPD) or asthma with a pre\-bronchodilatory forced expiratory volume in 1 second (FEV1\) \<50% of predicted normal.
- •Note: FEV1 testing is required for patients suspected of having COPD or asthma.
- •6\. Received rituximab, belimumab, eculizumab, or any monoclonal antibody for immunomodulation within 6 months before first dosing. Patients with prior exposure to rituximab must have CD19 counts within the normal range at screening.
- •Known autoimmune disease other than MG that would interfere with the course and conduct of the study.
- •8\. Received a live vaccine within 4 weeks before screening or has any live vaccination planned during the study.
Outcomes
Primary Outcomes
Not specified
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