NCT03938545

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

ASCEND GO-2: A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled Study of RVT-1401 for the Treatment of Patients With Active, Moderate to Severe Graves' Ophthalmopathy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Immunovant Sciences GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Graves' Ophthalmopathy (GO)

Interventions

Type	Name	Description
DRUG	RVT-1401 (Administered via subcutaneous injection)	RVT-1401 is a fully human anti-neonatal Fc receptor (FcRn) monoclonal antibody.
OTHER	Placebo (Administered via subcutaneous injection)	Placebo

Timeline

• Start date: 2019-07-23
• Primary completion: 2021-02-02
• Completion: 2021-04-15
• First posted: 2019-05-06
• Last updated: 2022-09-22
• Results posted: 2022-09-22

Locations

25 sites across 5 countries: United States, Canada, Germany, Italy, Spain

Regulatory

• FDA-regulated drug study