Teprotumumab (RV 001) Treatment in Patients With Active Thyroid Eye Disease
NCT ID: NCT01868997
Last Updated: 2024-12-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
88 participants
INTERVENTIONAL
2013-07-31
2017-02-22
Brief Summary
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"Funding Source - FDA OOPD"
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
A placebo infusion (normal saline) administered q3W by IV infusion over a period of 24 weeks for a total of 8 infusions.
normal saline
Teprotumumab
Teprotumumab administered q3W by IV infusion over a period of 24 weeks for a total of 8 infusions. All participants start treatment at a dose of 10 mg/kg. At Week 3, the dose is escalated to 20 mg/kg and kept constant for the remainder of the study.
teprotumumab
Interventions
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teprotumumab
normal saline
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Fewer than 9 months from onset of TED
* No previous medical or surgical treatment, excluding local supportive measures and oral steroids if the maximum cumulative dose is less than 1000 mg methylprednisolone or equivalent with at least 6 weeks between last administration of oral steroids and randomization
* Euthyroid or with mild hypo or hyperthyroidism defined as free thyroxine (FT4) and free triiodothyronine (FT3) levels less than 50% above or below the normal limits (every effort should be made to correct the mild hypo- or hyperthyroidism promptly)
Exclusion Criteria
* Corneal decompensation unresponsive to medical management
* Oral or IV steroid treatment for any non-TED reason in the preceding 3 months
* Poorly controlled diabetes
* Platelets \< 100 x 10\^9/L
* Hemoglobin concentration \> 2 g/dL below the lower limit of normal
18 Years
75 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Jules Stein Eye Institute at UCLA
Los Angeles, California, United States
University of Denver
Aurora, Colorado, United States
Emory University Department of Ophthalmology
Atlanta, Georgia, United States
University of Iowa Hospitals and Clinics, Department of Ophthalmology
Iowa City, Iowa, United States
Kellogg Eye Center at University of Michigan
Ann Arbor, Michigan, United States
Washington University Department of Ophthalmology
St Louis, Missouri, United States
University of Nebraska Medical Center Department of Ophthalmology
Omaha, Nebraska, United States
Casey Eye Institute at Oregon Health and Science University
Portland, Oregon, United States
Hamilton Eye Institute at University of Tennessee
Memphis, Tennessee, United States
Eye Wellness Center
Houston, Texas, United States
Medical College of Wisconsin, The Eye Institute
Milwaukee, Wisconsin, United States
Johannes Gutenberg University Medical Center
Mainz, , Germany
Fondazione Ca' Granda Ospedale Policlinico Graves GO Center
Milan, , Italy
University of Pisa, Azienda Ospedaliera
Pisa, , Italy
Moorfields Eye Hospital
London, , United Kingdom
Countries
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References
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Smith TJ, Kahaly GJ, Ezra DG, Fleming JC, Dailey RA, Tang RA, Harris GJ, Antonelli A, Salvi M, Goldberg RA, Gigantelli JW, Couch SM, Shriver EM, Hayek BR, Hink EM, Woodward RM, Gabriel K, Magni G, Douglas RS. Teprotumumab for Thyroid-Associated Ophthalmopathy. N Engl J Med. 2017 May 4;376(18):1748-1761. doi: 10.1056/NEJMoa1614949.
Xin Y, Xu F, Gao Y, Bhatt N, Chamberlain J, Sile S, Hammel S, Holt RJ, Ramanathan S. Pharmacokinetics and Exposure-Response Relationship of Teprotumumab, an Insulin-Like Growth Factor-1 Receptor-Blocking Antibody, in Thyroid Eye Disease. Clin Pharmacokinet. 2021 Aug;60(8):1029-1040. doi: 10.1007/s40262-021-01003-3. Epub 2021 Mar 26.
Wang Y, Smith TJ. Current concepts in the molecular pathogenesis of thyroid-associated ophthalmopathy. Invest Ophthalmol Vis Sci. 2014 Mar 20;55(3):1735-48. doi: 10.1167/iovs.14-14002.
Other Identifiers
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FD004792-01A1
Identifier Type: OTHER
Identifier Source: secondary_id
2014-000113-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
TED01RV
Identifier Type: -
Identifier Source: org_study_id