Teprotumumab (RV 001) Treatment in Patients With Active Thyroid Eye Disease

Completed · Phase 2 · Has a placebo group

Conditions studied: Thyroid Associated Ophthalmopathies, Thyroid-Associated Ophthalmopathy

In brief

The primary objective of this study is to investigate the efficacy, safety, and tolerability of RV 001 (teprotumumab), a fully human anti-IGF1R antibody, administered q3W for 6 months, in comparison to placebo, in the treatment of participants suffering from active TED. "Funding Source - FDA OOPD"

Key facts

Study ID

NCT01868997

Run by

Amgen

People needed

88

Starts

2013-07-01

Expected to finish

2017-02-22

Last updated by the study team

2024-12-17

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical diagnosis of Graves' disease associated with active TED and a clinical activity score of ≥ 4
• 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)

You may not qualify if…

• Optic neuropathy
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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