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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-19

Study Completion Date

2017-04-24

Brief Summary

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

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Detailed Description

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Conditions

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Graves' Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CFZ533 10mg/kg

CFZ533 intravenously over approximately one hour

Group Type EXPERIMENTAL

CFZ533

Intervention Type DRUG

CFZ533 intravenously over approximately one hour

Interventions

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CFZ533

CFZ533 intravenously over approximately one hour

Intervention Type DRUG

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No