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
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?
- 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.
- 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