A Study to Evaluate the Safety and Effect of CFZ533 on Patients With Graves' Disease
A Study to Evaluate the Safety and Effect of CFZ533 on Patients With Graves' Disease
An open label study to evaluate the safety and efficacy of CFZ533 following 12 weeks
 treatment in patients with Graves' disease
Key Inclusion Criteria:

 -  Male and female patients 18 to 65 years of age included.

 -  Women of child-bearing potential must be willing to use highly effective methods of
 contraception during the study treatment epoch and for 12 weeks after the last study
 treatment.

 -  Graves' hyperthyroidism, with the following labs measured at screening:

 -  TSH<LLN and either FT3>ULN or FT4> ULN and

 -  TRAb ≥ 2.5 IU/L

 -  Patients must weigh at least 40 kg to participate in the study

 Key Exclusion Criteria:

 -  History of treatment of Graves' disease with radio-iodine ablation or thyroidectomy
 and/or current treatment with anti-thyroid drugs (methimazole or propylthiouracil)
 within one week of starting the study treatment

 -  History of hyperthyroidism not caused by Graves' disease (e.g. toxic multinodular
 goiter, autonomous thyroid nodule, or acute inflammatory thyroiditis) and/or history
 or presence of thyroid storm (fever, profuse sweating, vomiting, diarrhea, delirium,
 severe weakness, seizures, markedly irregular heartbeat, yellow skin and eyes
 (jaundice), severe low blood pressure, and coma).

 -  Previous treatment with a B cell-depleting biologic agent or any other
 immune-modulatory biologic agent within 5 half-lives (experimental or approved).

 -  History of recurrent clinically significant infection or of recurrent bacterial
 infections with encapsulated organisms.

 -  History of primary or secondary immunodeficiency, including a positive HIV (ELISA and
 Western blot) test result.

 -  History or evidence of tuberculosis by either of the following tests:

 -  Positive PPD skin test (size of induration measured after 48-72 hours, and a positive
 result is defined as an induration of ≥ 5mm or according to local practice/guidelines)
 OR

 -  Positive QuantiFERON TB-Gold test

 -  Plans for immunization with a live vaccine within a 2-month period before enrollment
 or during the study period.

 -  Treatment with immunomodulatory drugs, such as cyclosporine A, methotrexate, and/or
 cyclophosphamide within 3 months from baseline. Glucocorticosteroid therapy with
 prednisolone up to 10 mg daily is permitted if patients are on stable dose for more
 than 3 months before enrollment in the study.

 -  Pregnant, breastfeeding females, and women of child bearing potential unless they are
 using highly effective contraception