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

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ClinicalTrials.gov Identifier: NCT03922321
Recruitment Status : Recruiting
First Posted : April 19, 2019
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
Immunovant Sciences GmbH

Brief Summary:
The purpose of the current study is to confirm safety/tolerability and key pharmacodynamic (PD) effects that are considered to drive clinical benefit in GO patients.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Open label study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2a, Multicenter, Open-Label Study of RVT-1401 for the Treatment of Patients With Moderate to Severe Active Graves' Ophthalmopathy
Actual Study Start Date : April 22, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Arm Intervention/treatment
Experimental: Open Label RVT-1401
Open Label RVT-1401 weekly 680 mg for two weeks followed by weekly 340 mg for four weeks
Drug: RVT-1401 (Administered via subcutaneous injection)
RVT-1401 is a fully human anti-neonatal Fc receptor (FcRn) monoclonal antibody.




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. Percentage change from baseline in total IgG and IgG subclasses (1-4) [ Time Frame: 7 Weeks ]
  3. Percentage change in levels of anti-TSHR antibodies [ Time Frame: 7 Weeks ]

Secondary Outcome Measures :
  1. Percent change from baseline in proptosis [ Time Frame: 7 Weeks ]
  2. Total number of proptosis responders [ Time Frame: 7 Weeks ]
  3. Pharmacokinetics (PK) Parameters of AUC (0-168 h) after first and last dose [ Time Frame: 7 Weeks ]
  4. Pharmacokinetics (PK) maximum concentration (Cmax) after first and last dose [ Time Frame: 7 Weeks ]
  5. Concentration of RVT-1401 pre-dose (Ctrough) [ Time Frame: 7 Weeks ]
  6. Immunogenicity determined by number of participants with positive anti-RVT-1401 antibodies and characterization of any anti-RVT-1401 antibodies to confirm neutralization potential [ 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 (on the 7-item scale) and Baseline (on the 10-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): NCT03922321


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

Locations
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Canada, British Columbia
UBC/VGH Eye Care Center Not yet recruiting
Vancouver, British Columbia, Canada, V5Z 3N9
Contact: Study Coordinator         
Principal Investigator: Dolman, MD         
Canada, Ontario
Toronto Retina Institute Recruiting
North York, Ontario, Canada, M3C 0G9
Contact: Study Coordinator         
Principal Investigator: Tucker, MD         
University of Ottwa Eye Institute Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Study Coordinator         
Principal Investigator: Jordan, MD         
Canada, Quebec
CIUSSS de I'Est-de-I'lle-de-Montreal, Installation Maisonneuve- Rosemont Not yet recruiting
Montreal, Quebec, Canada, H1T 2M4
Contact: Study Coordinator         
Principal Investigator: Hardy, MD         
Sponsors and Collaborators
Immunovant Sciences GmbH

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Responsible Party: Immunovant Sciences GmbH
ClinicalTrials.gov Identifier: NCT03922321     History of Changes
Other Study ID Numbers: RVT-1401-1002
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: June 11, 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
Product Manufactured in and Exported from the U.S.: Yes

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