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


Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

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.

Who is eligible to participate?

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

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