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 (GO)

Active Clinical Trials // Jun 12 2019

Sponsor: Immunovant Sciences GmbH
Principal Investigator: Mark Lucarelli, MD
Study Coordinator: Angie Adler

Study Objective:

The purpose of this study is to assess the efficacy and safety/tolerability of three dose regimens of RVT-1401 (administered subcutaneously) 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.

Study Design:

This is a 4-arm randomized, interventional, multicenter study.

Treatment arms are:

  • RVT-1401 680 mg weekly for 6 weeks
  • RVT-1401 340 mg weekly for 6 weeks
  • RVT-1401 255 mg weekly for 6 weeks
  • Placebo weekly for 6 weeks

Diagnosis and Key Eligibility Criteria:

Patients over the age of 18 with a clinical diagnosis of Graves’ disease with hyperthyroidism associated with active, moderate to severe GO with onset within 9 months of screening.

Duration of Study: 24 weeks

 

For more information, contact Angie Adler 608-265-7557.