A Study to Evaluate the Safety and Effect of CFZ533 on 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:

- TSHULN 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