A Study to Evaluate the Safety and Effect of CFZ533 on Patients with Graves' Disease

Overview

About this study

The purpose of this study is to evaluate the safety and effectiveness of CFZ533 following 12 weeks of treatment in patients with Graves' disease.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Male and female 
  • 18 to 65 years of age
  • Women of child-bearing potential must be willing to use highly effective methods of contraception during study treatment and for 12 weeks after the last study treatment
  • Grave's hyperthyroidism diagnosed within approximately the last 6 months prior to screening
  • Patients must weigh at least 40 kg to participate in the study

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 3 months 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 or breastfeeding females
  • Women of child bearing potential who will not use highly effective contraception

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Marius Stan, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Additional contact information

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