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

• Status: Completed
• Trial end date: 2017-02-22
• Target enrollment: 0
• Participant gender: All

Summary

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"

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Horizon Pharma USA, Inc.; River Vision Development Corporation

Criteria

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