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出境医 / 临床实验 / ASCEND GO-2: Study of RVT-1401 for the Treatment of Patients With Active, Moderate to Severe Graves' Ophthalmopathy ( GO )

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

Study Description
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

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: ASCEND GO-2: 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
Actual Study Start Date : July 23, 2019
Actual Primary Completion Date : February 2, 2021
Actual Study Completion Date : April 15, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Regimen A-RVT-1401
Regimen A= RVT-1401 680 mg weekly for 12 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 12 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 12 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 12 weeks
 Other: Placebo (Administered via subcutaneous injection)
Placebo
Outcome Measures
Primary Outcome Measures :
  1. Assessment of safety by analysis of adverse events (AEs) data [ Time Frame: 13 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 responders in study eye without deterioration in fellow eye at the end of treatment [ Time Frame: 13 weeks ]

Secondary Outcome Measures :
  1. Proptosis responder rate [ Time Frame: Weeks 1-12, weeks 14-20 ]
  2. Change from baseline in proptosis [ Time Frame: 20 weeks ]
  3. Change from baseline in Clinical Activity Score (CAS) [ Time Frame: 20 weeks ]
  4. Proportion of participants with overall ophthalmic improvement [ Time Frame: 20 weeks ]
  5. Change from baseline in the Gorman Score for diplopia [ Time Frame: 20 weeks ]
  6. Change from baseline in the Graves' Ophthalmopathy Quality of Life (GO-QOL) [ Time Frame: 20 weeks ]
  7. Proportion of patients with Clinical Activity Score (CAS) of 0 or 1 [ Time Frame: 20 weeks ]

Eligibility Criteria
Layout table for eligibility information
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 (IV, 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 < 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
Contacts and Locations

Locations
Show Show 25 study locations
Sponsors and Collaborators
Immunovant Sciences GmbH
Tracking Information
First Submitted Date  ICMJE May 1, 2019
First Posted Date  ICMJE May 6, 2019
Last Update Posted Date June 3, 2021
Actual Study Start Date  ICMJE July 23, 2019
Actual Primary Completion Date February 2, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 26, 2019)
  • Assessment of safety by analysis of adverse events (AEs) data [ Time Frame: 13 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.
  • Proportion of proptosis responders in study eye without deterioration in fellow eye at the end of treatment [ Time Frame: 13 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 2, 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.
  • Proportion of proptosis responsers in study eye without deterioration in fellow eye at the end of treatment [ Time Frame: 7 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2019)
  • Proptosis responder rate [ Time Frame: Weeks 1-12, weeks 14-20 ]
  • Change from baseline in proptosis [ Time Frame: 20 weeks ]
  • Change from baseline in Clinical Activity Score (CAS) [ Time Frame: 20 weeks ]
  • Proportion of participants with overall ophthalmic improvement [ Time Frame: 20 weeks ]
  • Change from baseline in the Gorman Score for diplopia [ Time Frame: 20 weeks ]
  • Change from baseline in the Graves' Ophthalmopathy Quality of Life (GO-QOL) [ Time Frame: 20 weeks ]
  • Proportion of patients with Clinical Activity Score (CAS) of 0 or 1 [ Time Frame: 20 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2019)
  • Proptosis responder rate [ Time Frame: Weeks 1-6, weeks 8-18 ]
  • Change from baseline in proptosis [ Time Frame: 7 weeks ]
  • Change from baseline in Clinical Activity Score (CAS) [ Time Frame: 7 weeks ]
  • Proportion of participants with overall ophthalmic improvement [ Time Frame: 7 weeks ]
  • Change from baseline in the Gorman Score for diplopia [ Time Frame: 7 weeks ]
  • Change from baseline in the Graves' Ophthalmopathy Quality of Life (GO-QOL) [ Time Frame: 7 weeks ]
  • Proportion of patients with Clinical Activity Score (CAS) of 0 or 1 [ Time Frame: 7 Weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ASCEND GO-2: Study of RVT-1401 for the Treatment of Patients With Active, Moderate to Severe Graves' Ophthalmopathy ( GO )
Official Title  ICMJE ASCEND GO-2: 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Graves' Ophthalmopathy (GO)
Intervention  ICMJE
  • Drug: RVT-1401 (Administered via subcutaneous injection)
    RVT-1401 is a fully human anti-neonatal Fc receptor (FcRn) monoclonal antibody.
  • Other: Placebo (Administered via subcutaneous injection)
    Placebo
Study Arms  ICMJE
  • Experimental: Regimen A-RVT-1401
    Regimen A= RVT-1401 680 mg weekly for 12 weeks
    Intervention: Drug: RVT-1401 (Administered via subcutaneous injection)
  • Experimental: Regimen B-RVT-1401
    Regimen B= RVT-1401 340 mg weekly for 12 weeks
    Intervention: Drug: RVT-1401 (Administered via subcutaneous injection)
  • Experimental: Regimen C-RVT-1401
    Regimen C= RVT-1401 255 mg weekly for 12 weeks
    Intervention: Drug: RVT-1401 (Administered via subcutaneous injection)
  • Placebo Comparator: Placebo
    for 12 weeks
    Intervention: Other: Placebo (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 Terminated
Actual Enrollment  ICMJE
 (submitted: May 31, 2021) 		65
Original Estimated Enrollment  ICMJE
 (submitted: May 2, 2019) 		70
Actual Study Completion Date  ICMJE April 15, 2021
Actual Primary Completion Date February 2, 2021   (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 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 (IV, 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 < 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,   Germany,   Italy,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03938545
Other Study ID Numbers  ICMJE RVT-1401-2001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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 May 2021

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

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