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

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 participants. In addition, the study is designed to characterize the effect of RVT-1401 exposure on reduction in anti-TSHR IgG

Timeline

Start

2019-07-23

Primary completion

2021-02-02

Completion

2021-04-15

Outcome

Missed primary endpoint

Stopped (Business): “Sponsor decision based on premature unblinding of treatment allocations necessitated by program-wide review”

registry analysis (superiority test); RVT-1401 680 mg/Week vs Placebo; p =0.1993; Risk Difference (RD) 21.4 (95% CI -11.3 to 54.1) NCT03938545 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Batoclimab	Monoclonal antibody	255 mg	Subcutaneous
Subject	Batoclimab	Monoclonal antibody	340 mg	Subcutaneous
Subject	Batoclimab	Monoclonal antibody	680 mg	Subcutaneous

Indications