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Trial record 1 of 1 for:    NCT03922321
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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 : Active, not recruiting
First Posted : April 19, 2019
Last Update Posted : August 13, 2020
Sponsor:
Information provided by (Responsible Party):
Immunovant Sciences GmbH

Tracking Information
First Submitted Date  ICMJE April 17, 2019
First Posted Date  ICMJE April 19, 2019
Last Update Posted Date August 13, 2020
Actual Study Start Date  ICMJE April 22, 2019
Actual Primary Completion Date February 29, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2019)
  • 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.
  • Percentage change from baseline in total IgG and IgG subclasses (1-4) [ Time Frame: 7 Weeks ]
  • Percentage change in levels of anti-TSHR antibodies [ Time Frame: 7 Weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2019)
  • Percent change from baseline in proptosis [ Time Frame: 7 Weeks ]
  • Total number of proptosis responders [ Time Frame: 7 Weeks ]
  • Pharmacokinetics (PK) Parameters of AUC (0-168 h) after first and last dose [ Time Frame: 7 Weeks ]
  • Pharmacokinetics (PK) maximum concentration (Cmax) after first and last dose [ Time Frame: 7 Weeks ]
  • Concentration of RVT-1401 pre-dose (Ctrough) [ Time Frame: 7 Weeks ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of RVT-1401 for the Treatment of Patients With Moderate to Severe Active Graves' Ophthalmopathy ( GO )
Official Title  ICMJE A Phase 2a, Multicenter, Open-Label Study of RVT-1401 for the Treatment of Patients With Moderate to Severe Active Graves' Ophthalmopathy
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Open label study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Graves' Ophthalmopathy
Intervention  ICMJE Drug: RVT-1401 (Administered via subcutaneous injection)
RVT-1401 is a fully human anti-neonatal Fc receptor (FcRn) monoclonal antibody.
Study Arms  ICMJE Experimental: Open Label RVT-1401
Open Label RVT-1401 weekly 680 mg for two weeks followed by weekly 340 mg for four weeks
Intervention: Drug: RVT-1401 (Administered via subcutaneous injection)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 4, 2020)
7
Original Estimated Enrollment  ICMJE
 (submitted: April 17, 2019)
8
Estimated Study Completion Date  ICMJE September 2020
Actual Primary Completion Date February 29, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03922321
Other Study ID Numbers  ICMJE RVT-1401-1002
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Immunovant Sciences GmbH
Study Sponsor  ICMJE Immunovant Sciences GmbH
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Immunovant Sciences GmbH
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP