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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02713256
Recruitment Status : Completed
First Posted : March 18, 2016
Results First Posted : May 21, 2018
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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

Condition or disease Intervention/treatment Phase
Graves' Disease Drug: CFZ533 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Study to Evaluate the Safety and Efficacy of 12 Week Treatment With CFZ533 in Patients With Graves' Disease
Actual Study Start Date : April 19, 2016
Actual Primary Completion Date : April 24, 2017
Actual Study Completion Date : April 24, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CFZ533 10mg/kg
CFZ533 intravenously over approximately one hour
Drug: CFZ533
CFZ533 intravenously over approximately one hour




Primary Outcome Measures :
  1. Percentage of Participants Whose Thyroid Stimulating Hormone (TSH) Levels Normalize After 12 Week Treatment [ Time Frame: 12 week (DAY 85) ]
    Normalization of TSH is defined as TSH level greater than 0.35 mU/L after 12 week treatment (Day 85)

  2. Percentage of Participants Whose Total Triiodothyronine (Total T3) Levels Decrease After 12 Week Treatment [ Time Frame: 12 week (DAY 85) ]
    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

  3. Percentage of Participants Whose Free Thyroxine (Free T4) Levels Decrease After 12 Week Treatment [ Time Frame: 12 week (DAY 85) ]
    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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02713256


Locations
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United States, Hawaii
Novartis Investigative Site
Honolulu, Hawaii, United States, 96814
United States, Minnesota
Novartis Investigative Site
Rochester, Minnesota, United States, 55905
Germany
Novartis Investigative Site
Mainz, Germany, 55131
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Novartis ( Novartis Pharmaceuticals ):
Study Protocol  [PDF] May 18, 2016
Statistical Analysis Plan  [PDF] June 19, 2017

Additional Information:
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02713256    
Other Study ID Numbers: CCFZ533X2205
2015-005564-41 ( EudraCT Number )
First Posted: March 18, 2016    Key Record Dates
Results First Posted: May 21, 2018
Last Update Posted: April 11, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Graves' disease
Hyperthyroidism
CFZ533
TSH
Additional relevant MeSH terms:
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Graves Disease
Exophthalmos
Orbital Diseases
Eye Diseases
Goiter
Thyroid Diseases
Endocrine System Diseases
Hyperthyroidism
Autoimmune Diseases
Immune System Diseases