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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Graves' Ophthalmopathy (GO)

In brief

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

Key facts

Study ID

NCT03938545

Run by

Immunovant Sciences GmbH

People needed

65

Starts

2019-07-23

Expected to finish

2021-04-15

Last updated by the study team

2022-09-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female ≥18 years of age.
• Clinical diagnosis of Graves' disease with hyperthyroidism associated with active, moderate to severe Graves' Ophthalmopathy (GO) with a Clinical Activity Score (CAS) ≥4 for the most severely affected eye at Screening and Baseline (on the 7-item scale).
• Onset of active GO within 9 months of screening.
• 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 millimeters (mm), moderate or severe soft tissue involvement, proptosis ≥3 mm above normal for race and gender, and/or inconstant or constant diplopia.
• Other, more specific inclusion criteria are defined in the protocol

You may not qualify if…

• Use of any steroid (intravenous, 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.
• Use of rituximab, tocilizumab, or any monoclonal antibody for immunomodulation within the past 9 months prior to Baseline.
• Total IgG level <6 grams per liter (g/L) at Screening.
• Absolute neutrophil count <1500 cells per meter squared (cells/mm\^3) at Screening.
• 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.
• Previous orbital irradiation or surgery for GO.
• Other, more specific exclusion criteria are defined in the protocol

Where it is running

• Multispecialty Aesthetic Clinical Research Organziation (MACRO) — Beverly Hills, California, United States
• Doheny Eye Center UCLA — Pasadena, California, United States
• University of Miami Miller School of Medicine Bascom Palmer Eye Institute — Miami, Florida, United States
• University of Iowa Hospitals & Clinics - Eye Clinic — Iowa City, Iowa, United States
• University of Michigan - Kellogg Eye Center — Ann Arbor, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University School of Medicine - Center for Advanced Medicine (CAM) - Eye Center — St Louis, Missouri, United States
• University of Rochester Medical Center — Rochester, New York, United States
• Oregon Health & Science University (OHSU) - Casey Eye Institute (CEI)-Marquam Hill — Portland, Oregon, United States
• Eye Wellness Center — Houston, Texas, United States
• Eyelid Center of Utah — Salt Lake City, Utah, United States
• West Virginia University Eye Institute — Morgantown, West Virginia, United States
• University of British Columbia — Vancouver, British Columbia, Canada
• Toronto Retina Institute — North York, Ontario, Canada
• University of Ottawa Eye Institute — Ottawa, Ontario, Canada
• Ophthalmology University Center- Hôpital Maisonneuve-Rosemont — Montreal, Quebec, Canada
• Universitat Duisburg-Essen — Duisburg, Germany
• Orbitazentrum Frankfurt — Frankfurt am Main, Germany
• Universitätsmedizin Mainz — Mainz, Germany
• ARNAS Garibaldi, Presidio di Nesima — Palermo, Catania, Italy
• Fondazione IRCCS Cà Granda-Ospedale Maggiore Policlinico — Milan, Italy
• Unità Operativa di Endocrinologia 2, Azienda Ospedaliero-Universitaria Pisana — Pisa, Italy
• Hospital Universitari de Bellvitge — L'Hospitalet de Llobregat, Barcelona, Spain
• Centro de Oftalmologia Barraquer — Barcelona, Spain
• University Hospital Ramon y Cajal — Madrid, Spain

Full record on ClinicalTrials.gov

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