Graves' Disease Clinical Trial
Official title:
An Open Label Study to Evaluate the Safety and Efficacy of 12 Week Treatment With CFZ533 in Patients With Graves' Disease
Verified date | March 2019 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
An open label study to evaluate the safety and efficacy of CFZ533 following 12 weeks treatment in patients with Graves' disease
Status | Completed |
Enrollment | 15 |
Est. completion date | April 24, 2017 |
Est. primary completion date | April 24, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Novartis Investigative Site | Mainz | |
United States | Novartis Investigative Site | Honolulu | Hawaii |
United States | Novartis Investigative Site | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
United States, Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants Whose Thyroid Stimulating Hormone (TSH) Levels Normalize After 12 Week Treatment | Normalization of TSH is defined as TSH level greater than 0.35 mU/L after 12 week treatment (Day 85) | 12 week (DAY 85) | |
Primary | Percentage of Participants Whose Total Triiodothyronine (Total T3) Levels Decrease After 12 Week Treatment | Percentage of participants whose total triiodothyronine (total T3) levels decrease after 12 week treatment. A decrease is when total T3 level is below Upper limit of normal (ULN) = 2.79 nmol/L | 12 week (DAY 85) | |
Primary | Percentage of Participants Whose Free Thyroxine (Free T4) Levels Decrease After 12 Week Treatment | Percentage of participants whose free thyroxine (free T4) levels decrease after 12 weeks of treatment (DAY85). A decrease is when free T4 level is below Upper limit of normal (ULN) = 22.7 pmol/L) | 12 week (DAY 85) |
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