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

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ClinicalTrials.gov Identifier: NCT03938545
Recruitment Status : Not yet recruiting
First Posted : May 6, 2019
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Immunovant Sciences GmbH

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

Condition or disease Intervention/treatment Phase
Graves' Ophthalmopathy (GO) Drug: RVT-1401 (Administered via subcutaneous injection) Other: Placebo (Administered via subcutaneous injection) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Arm Intervention/treatment
Experimental: Regimen A-RVT-1401
Regimen A= RVT-1401 680 mg weekly for 6 weeks
Drug: RVT-1401 (Administered via subcutaneous injection)
RVT-1401 is a fully human anti-neonatal Fc receptor (FcRn) monoclonal antibody.

Experimental: Regimen B-RVT-1401
Regimen B= RVT-1401 340 mg weekly for 6 weeks
Drug: RVT-1401 (Administered via subcutaneous injection)
RVT-1401 is a fully human anti-neonatal Fc receptor (FcRn) monoclonal antibody.

Experimental: Regimen C-RVT-1401
Regimen C= RVT-1401 255 mg weekly for 6 weeks
Drug: RVT-1401 (Administered via subcutaneous injection)
RVT-1401 is a fully human anti-neonatal Fc receptor (FcRn) monoclonal antibody.

Placebo Comparator: Placebo
for 6 weeks
Other: Placebo (Administered via subcutaneous injection)
Placebo




Primary Outcome Measures :
  1. Assessment of safety by analysis of adverse events (AEs) data [ Time Frame: 7 weeks ]
    AE summaries of the number and percent of participants reporting each event at least once will be generated. Other safety data will be summarized descriptively.

  2. Proportion of proptosis responsers in study eye without deterioration in fellow eye at the end of treatment [ Time Frame: 7 weeks ]

Secondary Outcome Measures :
  1. Proptosis responder rate [ Time Frame: Weeks 1-6, weeks 8-18 ]
  2. Change from baseline in proptosis [ Time Frame: 7 weeks ]
  3. Change from baseline in Clinical Activity Score (CAS) [ Time Frame: 7 weeks ]
  4. Proportion of participants with overall ophthalmic improvement [ Time Frame: 7 weeks ]
  5. Change from baseline in the Gorman Score for diplopia [ Time Frame: 7 weeks ]
  6. Change from baseline in the Graves' Ophthalmopathy Quality of Life (GO-QOL) [ Time Frame: 7 weeks ]
  7. Proportion of patients with Clinical Activity Score (CAS) of 0 or 1 [ Time Frame: 7 Weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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 mm, moderate or severe soft tissue involvement, proptosis ≥ 3 mm above normal for race and gender, and/or inconstant or constant diplopia.
  5. Other, more specific inclusion criteria are defined in the protocol

Exclusion Criteria:

  1. Use of any steroid (intravenous [IV] or oral) with a cumulative dose equivalent to ≥ 1 g of methylprednisolone for the treatment of GO within 3 weeks prior to Screening.
  2. Use of rituximab, tocilizumab, or any monoclonal antibody for immunomodulation within the past 9 months prior to Baseline.
  3. Total IgG level < 6g/L at Screening.
  4. Absolute neutrophil count <1500 cells/mm3 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.
  7. Other, more specific exclusion criteria are defined in the protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03938545


Contacts
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Contact: Central Study Contact 1-800-797-0414 clinicaltrials@immunovant.com

Locations
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United States, California
Multispecialty Aesthetic Clinical Research Organziation (MACRO) Not yet recruiting
Beverly Hills, California, United States, 90212
Principal Investigator: Douglas         
Doheny Eye Center UCLA Recruiting
Pasadena, California, United States, 91105
Principal Investigator: Rootman         
United States, Florida
University of Miami Miller School of Medicine Bascom Palmer Eye Institute Not yet recruiting
Miami, Florida, United States, 33136
Principal Investigator: Wester         
United States, Michigan
University of Michigan - Kellogg Eye Center Not yet recruiting
Ann Arbor, Michigan, United States, 48105
Principal Investigator: Nelson         
United States, Minnesota
Mayo Clinic Not yet recruiting
Rochester, Minnesota, United States, 55905
Principal Investigator: Marius         
United States, New York
University of Rochester Medical Center Not yet recruiting
Rochester, New York, United States, 14642
Principal Investigator: Feldon         
United States, Texas
Eye Wellness Center Recruiting
Houston, Texas, United States, 77005
Principal Investigator: Schiffman         
United States, Wisconsin
UW Health - University Station Clinic - Eye Care Services Recruiting
Madison, Wisconsin, United States, 53705-3644
Principal Investigator: Lucarelli         
Canada, British Columbia
University of British Columbia Not yet recruiting
Vancouver, British Columbia, Canada, V5Z-1M9
Principal Investigator: Dolman         
Canada, Ontario
Toronto Retina Institute Not yet recruiting
North York, Ontario, Canada, M3C 0G9
Contact: Study Coordinator         
Principal Investigator: Tucker, MD         
University of Ottawa Eye Institute Not yet recruiting
Ottawa, Ontario, Canada, K1H 8L6
Principal Investigator: Jordan         
Canada, Quebec
Ophthalmology University Center- Hôpital Maisonneuve-Rosemont Not yet recruiting
Montreal, Quebec, Canada, H1T 2M4
Principal Investigator: Hardy         
Germany
Universitat Duisburg-Essen Not yet recruiting
Duisburg, Germany, 47057
Principal Investigator: Eckstein         
Orbitazentrum Frankfurt Not yet recruiting
Frankfurt am Main, Germany, 60318
Principal Investigator: Pitz         
Johannes Gutenberg-Universitaet Mainz Universitaets-Hautklinik Not yet recruiting
Mainz, Germany, 55131
Principal Investigator: Kahaly         
Italy
Fondazione IRCCS Cà Granda-Ospedale Maggiore Policlinico Not yet recruiting
Milan, Italy, 20122
Principal Investigator: Salvi         
Unità Operativa di Endocrinologia 2, Azienda Ospedaliero-Universitaria Pisana Not yet recruiting
Pisa, Italy, 56124
Principal Investigator: Marino         
Spain
Centro de Oftalmologia Barraquer Not yet recruiting
Barcelona, Spain, 08021
Principal Investigator: Lopez Fortuny         
University Hospital Ramon y Cajal Not yet recruiting
Madrid, Spain, 28034
Principal Investigator: Sales-Sanz         
Sponsors and Collaborators
Immunovant Sciences GmbH

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Responsible Party: Immunovant Sciences GmbH
ClinicalTrials.gov Identifier: NCT03938545     History of Changes
Other Study ID Numbers: RVT-1401-2001
First Posted: May 6, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Immunovant Sciences GmbH:
IMVT-1401
Graves' Orbitopathy
Thyroid Eye Disease

Additional relevant MeSH terms:
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Eye Diseases
Graves Ophthalmopathy
Eye Diseases, Hereditary
Graves Disease
Exophthalmos
Orbital Diseases
Genetic Diseases, Inborn
Goiter
Thyroid Diseases
Endocrine System Diseases
Hyperthyroidism
Autoimmune Diseases
Immune System Diseases