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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/28/2021.

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

Clinicaltrials.gov identifier NCT03938545

Recruitment Status Recruiting

First Posted May 6, 2019

Last update posted February 17, 2020

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:Graves' Ophthalmopathy (GO)
  • Intervention/Treatment: Drug: RVT-1401 (Administered via subcutaneous injection)
    Other: Placebo (Administered via subcutaneous injection)
  • Phase: Phase 2
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • 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 2019
  • Estimated Primary Completion Date: January 2021
  • Estimated Study Completion Date: March 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
  • 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
Contacts

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

Locations
Show 21 Study Locations
Sponsors and Collaborators

Immunovant Sciences GmbH

More Information
  • 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: February 17, 2020
  • Last Verified: February 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • 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: Graves Ophthalmopathy Eye Diseases