ASCEND GO-2: Study of RVT-1401 for the Treatment of Patients With Active, Moderate to Severe Graves' Ophthalmopathy ( GO )
ASCEND GO-2: Study of RVT-1401 for the Treatment of Patients With Active, Moderate to Severe Graves' Ophthalmopathy ( GO )
The purpose of the current study is to assess the efficacy and safety/tolerability of three
 dose regimens of RVT-1401 in the treatment of active, moderate to severe GO patients. In
 addition, the study is designed to characterize the effect of RVT-1401 exposure on reduction
 in anti-TSHR IgG
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 and Baseline (on the 7-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 (IV, oral, steroid eye drops) for the treatment of GO or other
 conditions within 3 weeks prior to Screening. Steroids cannot be initiated during the
 trial. Exceptions include topical and inhaled steroids which are allowed.

 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