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ASCEND GO-2: 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 : Suspended (Sponsor decision to temporarily suspend enrollment while the program is reassessed.)
First Posted : May 6, 2019
Last Update Posted : February 9, 2021
Sponsor:
Information provided by (Responsible Party):
Immunovant Sciences GmbH

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 77 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
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Arms and Interventions
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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
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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
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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 (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
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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


Locations
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Sponsors and Collaborators
Immunovant Sciences GmbH
More Information
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Responsible Party: Immunovant Sciences GmbH
ClinicalTrials.gov Identifier: NCT03938545    
Other Study ID Numbers: RVT-1401-2001
First Posted: May 6, 2019    Key Record Dates
Last Update Posted: February 9, 2021
Last Verified: February 2021
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