Kurzfassung

This is a non-confirmatory, open-label, one treatment arm study in patients with newly diagnosed Graves’ disease. A total of approximately 15 patients will be enrolled and treated with CFZ533 to ensure approximately 12 completers. For each patient, the study will consist of a screening epoch of up to 28 days, a baseline evaluation, a 12-week treatment epoch, 24-week follow up epoch after the last dosing of CFZ533 on Study Day 85, and a study completion evaluation on Study Day 253. The...This is a non-confirmatory, open-label, one treatment arm study in patients with newly diagnosed Graves’ disease. A total of approximately 15 patients will be enrolled and treated with CFZ533 to ensure approximately 12 completers. For each patient, the study will consist of a screening epoch of up to 28 days, a baseline evaluation, a 12-week treatment epoch, 24-week follow up epoch after the last dosing of CFZ533 on Study Day 85, and a study completion evaluation on Study Day 253. The baseline visit can be skipped and the baseline assessments would be completed prior to the study treatment on Day 1 if Day 1 is scheduled within 7 days of the screening visit. Patients who discontinue the drug before having completed 4 weeks of treatment (including 4 week efficacy and safety evaluations) will be replaced with a newly enrolled patient. Patients who meet the eligibility criteria at screening will be admitted to baseline evaluations. Eligible patients will enter the study to receive treatment with CFZ533 at 10 mg/kg IV infusion over approximately one hour. All IV infusions will take place in a monitored facility. Patients will be monitored closely for at least 2 hours after the completion of IV infusion, at the discretion of the Investigator, for vital signs and adverse events, including development of an injection reaction. Patients will be discharged if the investigator identifies no safety concerns. Eligible patients will visit the study center in the morning of Study Days 1, 15, 29, 57 and 85 for IV administration of CFZ533. PK/PD blood samples will be collected during study center visits prior to the dose and 2-hours post-dose. Patients will return to the site periodically for follow up assessments (safety, PK and PD) as defined in the assessment table. The End of Study visit will take place on Day 253.
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