A Study to Evaluate the Safety and Effect of CFZ533 on Patients With Graves' Disease
Condition: Graves' Disease
MeSH terms: Graves Disease
Intervention: CFZ533
Intervention description: CFZ533 intravenously over approximately one hour
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Graves' disease; Hyperthyroidism; CFZ533; TSH

Summary:

      An open label study to evaluate the safety and efficacy of CFZ533 following 12 weeks
      treatment in patients with Graves' disease
    

Eligibility criteria:

        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