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Clinical Trials/EUCTR2015-005564-41-DE
EUCTR2015-005564-41-DE
Active, not recruiting
Phase 1

An open label study to evaluate the safety and efficacy of 12 week treatment with CFZ533 in patients with Graves'disease - CCFZ533X2205

ovartis Pharma Services AG0 sites15 target enrollmentApril 11, 2016
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ConditionsGraves' diseaseMedDRA version: 19.0Level: LLTClassification code 10018706Term: Graves' diseaseSystem Organ Class: 100000004860Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Graves' disease
Sponsor
ovartis Pharma Services AG
Enrollment
15
Status
Active, not recruiting
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 11, 2016
End Date
TBD
Last Updated
8 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •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
  • •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:

Exclusion Criteria

  • •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.

Outcomes

Primary Outcomes

Not specified

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