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

• Status: Completed
• Trial end date: 2017-04-24
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

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:

• 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