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Teprotumumab Treatment in Patients With Active Thyroid Eye Disease

This study is currently recruiting participants.
Verified January 2014 by River Vision Development Corporation
Information provided by (Responsible Party):
River Vision Development Corporation Identifier:
First received: May 2, 2013
Last updated: April 16, 2014
Last verified: January 2014

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
Administered as an infusion every 3 weeks for 8 total over 6 months.
Drug: Placebo
Experimental: teprotumumab
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


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

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
Please refer to this study by its identifier: NCT01868997

Contact: Amber Sarot 619-334-6502
Contact: Jeannette Reed 215-282-5459

  Show 19 Study Locations
Sponsors and Collaborators
River Vision Development Corporation
Principal Investigator: Raymond S Douglas, MD,PhD University of Michigan
  More Information

No publications provided

Responsible Party: River Vision Development Corporation Identifier: NCT01868997     History of Changes
Other Study ID Numbers: TED01RV
Study First Received: May 2, 2013
Last Updated: April 16, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Eye Diseases
Thyroid Diseases
Eye Diseases, Hereditary
Graves Ophthalmopathy
Endocrine System Diseases
Graves Disease
Orbital Diseases
Autoimmune Diseases
Immune System Diseases processed this record on April 17, 2014