Study of RVT-1401 for the Treatment of Patients With Moderate to Severe Active Graves' Ophthalmopathy ( GO )
Study of RVT-1401 for the Treatment of Patients With Moderate to Severe Active Graves' Ophthalmopathy ( GO )
The purpose of the current study is to confirm safety/tolerability and key pharmacodynamic
 (PD) effects that are considered to drive clinical benefit in GO patients.
Inclusion Criteria:

 1. Male or female ≥ 18 years of age.

 2. Clinical diagnosis of Graves' disease with hyperthyroidism associated with active,
 moderate to severe GO with a Clinical Activity Score (CAS) ≥ 4 for the most severely
 affected eye at Screening (on the 7-item scale) and Baseline (on the 10-item scale).

 3. Onset of active GO within 9 months of screening.

 4. Moderate-to-severe active GO (not sight-threatening but has an appreciable impact on
 daily life), usually associated with one or more of the following: lid retraction ≥ 2
 mm, moderate or severe soft tissue involvement, proptosis ≥ 3 mm above normal for race
 and gender, and/or inconstant or constant diplopia.

 5. Other, more specific inclusion criteria are defined in the protocol

 Exclusion Criteria:

 1. Use of any steroid (intravenous [IV] or oral) with a cumulative dose equivalent to ≥ 1
 g of methylprednisolone for the treatment of GO within 3 weeks prior to Screening.

 2. Use of rituximab, tocilizumab, or any monoclonal antibody for immunomodulation within
 the past 9 months prior to Baseline.

 3. Total IgG level < 6g/L at Screening.

 4. Absolute neutrophil count <1500 cells/mm3 at Screening.

 5. Participants with decreased best corrected visual acuity due to optic neuropathy as
 defined by a decrease in vision of 2 lines on the Snellen chart, new visual field
 defect, or color defect secondary to optic nerve involvement within the last 6 months
 at Screening.

 6. Previous orbital irradiation or surgery for GO.

 7. Other, more specific exclusion criteria are defined in the protocol