ASCEND GO-2: Study of RVT-1401 for the Treatment of Patients With Active, Moderate to Severe Graves' Ophthalmopathy ( GO )

• Status: Terminated
• Trial end date: 2021-04-15
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

• Lead Sponsor: Immunovant Sciences GmbH

Criteria

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