A study to evaluate the safety and effect of CFZ533 on patients with Graves’ disease
- Conditions
- Graves' diseaseMedDRA version: 19.0Level: LLTClassification code 10018706Term: Graves' diseaseSystem Organ Class: 100000004860Therapeutic area: Diseases [C] - Hormonal diseases [C19]
- Registration Number
- EUCTR2015-005564-41-DE
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 15
Main Inclusion Criteria:
1. 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.
2. Grave's hyperthyroidism.
3. Patients must weigh at least 40 kg to participate in the study.
• other protocol-defined inclusion criteria may apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Main Exclusion Criteria:
1. 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
2. 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).
3. Previous treatment with a B cell-depleting biologic agent or any other immune-modulatory biologic agent within 5 half-lives (experimental or approved).
4. History of recurrent clinically significant infection or of recurrent bacterial infections with encapsulated organisms.
5. History of primary or secondary immunodeficiency, including a positive HIV (ELISA and Western blot) test result.
6. 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
7. Plans for immunization with a live vaccine within a 2-month period before enrollment or during the study period.
8. 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.
9. Pregnant, breastfeeding females, and women of child bearing potential unless they are using highly effective contraception
• other protocol-defined exclusion criteria may apply
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the effects of CFZ533 on thyroid function (TSH) in Graves' disease patients after 12 weeks of treatment;Secondary Objective: To assess the safety and tolerability of CFZ533 for up to 36 weeks;Primary end point(s): Proportion of patients whose TSH levels normalize (above 0.35 mU/L) after 12 weeks of treatment. They will also be assessed by the difference in mean total T3 and free T4 between baseline and after 12 weeks of treatment.<br>;Timepoint(s) of evaluation of this end point: 12 weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Adverse events;Timepoint(s) of evaluation of this end point: 36 weeks