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

Sponsor
Immunovant Sciences GmbH (Industry)
Overall Status
Terminated
CT.gov ID
NCT03938545
Collaborator
(none)
65
Enrollment
25
Locations
4
Arms
20.8
Actual Duration (Months)
2.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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
  • Drug: RVT-1401 (Administered via subcutaneous injection)
  • Other: Placebo (Administered via subcutaneous injection)
 Phase 2

Study Design

Study Type:
Interventional
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 :
Jul 23, 2019
Actual Primary Completion Date :
Feb 2, 2021
Actual Study Completion Date :
Apr 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 [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 [13 weeks]

Secondary Outcome Measures

  1. Proptosis responder rate [Weeks 1-12, weeks 14-20]

  2. Change from baseline in proptosis [20 weeks]

  3. Change from baseline in Clinical Activity Score (CAS) [20 weeks]

  4. Proportion of participants with overall ophthalmic improvement [20 weeks]

  5. Change from baseline in the Gorman Score for diplopia [20 weeks]

  6. Change from baseline in the Graves' Ophthalmopathy Quality of Life (GO-QOL) [20 weeks]

  7. Proportion of patients with Clinical Activity Score (CAS) of 0 or 1 [20 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Site City State Country Postal Code
1 Multispecialty Aesthetic Clinical Research Organziation (MACRO) Beverly Hills California United States 90212
2 Doheny Eye Center UCLA Pasadena California United States 91105
3 University of Miami Miller School of Medicine Bascom Palmer Eye Institute Miami Florida United States 33136
4 University of Iowa Hospitals & Clinics - Eye Clinic Iowa City Iowa United States 52242
5 University of Michigan - Kellogg Eye Center Ann Arbor Michigan United States 48105
6 Mayo Clinic Rochester Minnesota United States 55905
7 Washington University School of Medicine - Center for Advanced Medicine (CAM) - Eye Center Saint Louis Missouri United States 63146
8 University of Rochester Medical Center Rochester New York United States 14642
9 Oregon Health & Science University (OHSU) - Casey Eye Institute (CEI)-Marquam Hill Portland Oregon United States 97239
10 Eye Wellness Center Houston Texas United States 77005
11 Eyelid Center of Utah Salt Lake City Utah United States 84102
12 West Virginia University Eye Institute Morgantown West Virginia United States 26506
13 University of British Columbia Vancouver British Columbia Canada V5Z-1M9
14 Toronto Retina Institute North York Ontario Canada M3C 0G9
15 University of Ottawa Eye Institute Ottawa Ontario Canada K1H 8L6
16 Ophthalmology University Center- Hôpital Maisonneuve-Rosemont Montreal Quebec Canada H1T 2M4
17 Universitat Duisburg-Essen Duisburg Germany 47057
18 Orbitazentrum Frankfurt Frankfurt am Main Germany 60318
19 Universitätsmedizin Mainz Mainz Germany 55131
20 ARNAS Garibaldi, Presidio di Nesima Palermo Catania Italy 95122
21 Fondazione IRCCS Cà Granda-Ospedale Maggiore Policlinico Milan Italy 20122
22 Unità Operativa di Endocrinologia 2, Azienda Ospedaliero-Universitaria Pisana Pisa Italy 56124
23 Hospital Universitari de Bellvitge Hospitalet de Llobregat Barcelona Spain 08907
24 Centro de Oftalmologia Barraquer Barcelona Spain 08021
25 University Hospital Ramon y Cajal Madrid Spain 28034

Sponsors and Collaborators

  • Immunovant Sciences GmbH

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Immunovant Sciences GmbH
ClinicalTrials.gov Identifier:
NCT03938545
Other Study ID Numbers:
  • RVT-1401-2001
First Posted:
May 6, 2019
Last Update Posted:
Jun 3, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
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:
Eye Diseases
Graves Ophthalmopathy

Study Results

No Results Posted as of Jun 3, 2021