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

Status:	Completed
Conditions:	Ocular, Endocrine
Therapuetic Areas:	Endocrinology, Ophthalmology
Healthy:	No
Age Range:	18 - 75
Updated:	4/27/2018
Start Date:	July 2013
End Date:	February 22, 2017

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)

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"

Inclusion Criteria:

- 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)

Exclusion Criteria:

- 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

We found this trial at

sites

University of Nebraska Medical Center, Department of Ophthalmology

Omaha, Nebraska 68198

from

Omaha, NE