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

NCT ID: NCT03938545

Last Updated: 2022-09-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-23
• Study Completion Date: 2021-04-15

Brief 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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Regimen A-RVT-1401

Regimen A= RVT-1401 680 mg weekly for 12 weeks

Group Type: EXPERIMENTAL

RVT-1401 (Administered via subcutaneous injection)

Intervention Type: DRUG

RVT-1401 is a fully human anti-neonatal Fc receptor (FcRn) monoclonal antibody.

Regimen B-RVT-1401

Regimen B= RVT-1401 340 mg weekly for 12 weeks

Group Type: EXPERIMENTAL

RVT-1401 (Administered via subcutaneous injection)

Intervention Type: DRUG

RVT-1401 is a fully human anti-neonatal Fc receptor (FcRn) monoclonal antibody.

Regimen C-RVT-1401

Regimen C= RVT-1401 255 mg weekly for 12 weeks

Group Type: EXPERIMENTAL

RVT-1401 (Administered via subcutaneous injection)

Intervention Type: DRUG

RVT-1401 is a fully human anti-neonatal Fc receptor (FcRn) monoclonal antibody.

Placebo

for 12 weeks

Group Type: PLACEBO_COMPARATOR

Placebo (Administered via subcutaneous injection)

Intervention Type: OTHER

Placebo

Interventions

RVT-1401 (Administered via subcutaneous injection)

RVT-1401 is a fully human anti-neonatal Fc receptor (FcRn) monoclonal antibody.

Intervention Type: DRUG

Placebo (Administered via subcutaneous injection)

Placebo

Intervention Type: OTHER

Eligibility 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 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).

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 millimeters (mm), moderate or severe soft tissue involvement, proptosis ≥3 mm above normal for race and gender, and/or inconstant or constant diplopia.

Exclusion Criteria

1. 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.

2. Use of rituximab, tocilizumab, or any monoclonal antibody for immunomodulation within the past 9 months prior to Baseline.

3. Total IgG level <6 grams per liter (g/L) at Screening.

4. Absolute neutrophil count <1500 cells per meter squared (cells/mm^3) 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Immunovant Sciences GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

United States; Canada; Germany; Italy; Spain

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

RVT-1401-2001

Identifier Type: -

Identifier Source: org_study_id