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Teprotumumab Treatment in Patients With Active Thyroid Eye Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by River Vision Development Corporation
Sponsor:
Information provided by (Responsible Party):
River Vision Development Corporation
ClinicalTrials.gov Identifier:
NCT01868997
First received: May 2, 2013
Last updated: November 13, 2014
Last verified: November 2014
  Purpose

The purpose of this study is to evaluate the safety, tolerability and effectiveness of a fully human antibody compared to placebo in the treatment of patients with active thyroid eye disease.


Condition Intervention Phase
Thyroid Associated Ophthalmopathies
Thyroid-Associated Ophthalmopathy
Drug: teprotumumab
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-masked, Placebo-controlled, Efficacy and Safety Study of an Insulin-like Growth Factor-1 Receptor (IGF-1R) Antagonist Antibody (Fully Human), in Patients With Active Thyroid Eye Disease

Resource links provided by NLM:


Further study details as provided by River Vision Development Corporation:

Primary Outcome Measures:
  • Clinical Activity Score [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical Severity Score [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 84
Study Start Date: April 2013
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Saline or teprotumumab
Administered as an infusion every 3 weeks for 8 total over 6 months.
Drug: Placebo
Normal saline solution
Other Name: Saline
Experimental: teprotumumab or saline
10mg/kg first infusion then 20mg/kg for remaining 7 infusions administered every 3 weeks over 6 months
Drug: teprotumumab
10mg/kg first infusion then 20mg/kg for remaining 7 infusions administered every 3 weeks over 6 months
Other Name: RV 001

Detailed Description:

A multicenter, double-masked, placebo-controlled, efficacy and safety study of RV 001, an insulin-like growth factor-1 receptor (IGF-1R) antagonist antibody (fully human), administered every 3 weeks (q3W) by intravenous (iv) infusion in patients suffering from active thyroid eye disease (TED)

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of Graves'disease associated with active thyroid eye disease and a clinical activity score of >4
  • Fewer than 9 months from onset of thyroid eye disease
  • No previous medical or surgical treatment, excluding local supportive measures and steroids if the maximum cumulative dose is less than 1000 mg methylprednisolone or equivalent with at least 6 weeks between last administration of 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:

  • Optic neuropathy
  • Corneal decompensation unresponsive to medical management
  • Oral or IV steroid treatment for any reason in the preceding 3 months
  • Poorly controlled diabetes
  • Platelets <100 x 109/L
  • Hemoglobin concentration > 2gr/dl below the lower limit of normal
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01868997

Contacts
Contact: Amber Sarot 619-334-6502 amber.sarot@premier-research.com
Contact: Jeannette Reed 215-282-5459 jeannette.reed@premier-research.com

Locations
United States, California
Jules Stein Eye Institute at UCLA Recruiting
Los Angeles, California, United States, 90095
United States, Colorado
University of Denver Recruiting
Aurora, Colorado, United States, 80045
United States, Georgia
Emory University Department of Ophthalmology Recruiting
Atlanta, Georgia, United States, 30322
United States, Iowa
University of Iowa Hospitals and Clinics, Department of Ophthalmology Recruiting
Iowa City, Iowa, United States, 52242
United States, Michigan
Kellogg Eye Center at University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48105
United States, Missouri
Washington University Department of Ophthalmology Recruiting
St Louis, Missouri, United States, 63110
United States, Nebraska
University of Nebraska Medical Center Department of Ophthalmology Recruiting
Omaha, Nebraska, United States, 68198
United States, Oregon
Casey Eye Institute at Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
United States, Pennsylvania
University of Pennsylvania - Scheie Eye Institute Recruiting
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Hamilton Eye Institute at University of Tennessee Recruiting
Memphis, Tennessee, United States, 38163
United States, Texas
Eye Wellness Center Recruiting
Houston, Texas, United States, 77005
United States, Washington
University of Washington Medicine Eye Institute Recruiting
Seattle, Washington, United States, 98014
United States, Wisconsin
Medical College of Wisconsin, The Eye Institute Recruiting
Milwaukee, Wisconsin, United States, 53226
Germany
University of Dusseldorf Medical Center Recruiting
Dusseldorf, Germany, 40225
Johannes Gutenberg University Medical Center Recruiting
Mainz, Germany, 55101
United Kingdom
Moorfields Eye Hospital Recruiting
London, United Kingdom
Sponsors and Collaborators
River Vision Development Corporation
Investigators
Principal Investigator: Raymond S Douglas, MD,PhD University of Michigan
  More Information

No publications provided by River Vision Development Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: River Vision Development Corporation
ClinicalTrials.gov Identifier: NCT01868997     History of Changes
Other Study ID Numbers: TED01RV
Study First Received: May 2, 2013
Last Updated: November 13, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by River Vision Development Corporation:
Thyroid Eye Disease, Graves Orbitopathy, Thyroid Associated
Ophthalmopathy

Additional relevant MeSH terms:
Eye Diseases
Thyroid Diseases
Eye Diseases, Hereditary
Graves Ophthalmopathy
Autoimmune Diseases
Endocrine System Diseases
Exophthalmos
Goiter
Graves Disease
Hyperthyroidism
Immune System Diseases
Orbital Diseases

ClinicalTrials.gov processed this record on November 24, 2014