ASCEND GO-2: Study of RVT-1401 for the Treatment of Patients With Active, Moderate to Severe Graves' Ophthalmopathy ( GO )
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 |
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Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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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.
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Placebo Comparator: Placebo for 12 weeks |
Other: Placebo (Administered via subcutaneous injection)
Placebo
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Outcome Measures
Primary Outcome Measures
- 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.
- Proportion of proptosis responders in study eye without deterioration in fellow eye at the end of treatment [13 weeks]
Secondary Outcome Measures
- Proptosis responder rate [Weeks 1-12, weeks 14-20]
- Change from baseline in proptosis [20 weeks]
- Change from baseline in Clinical Activity Score (CAS) [20 weeks]
- Proportion of participants with overall ophthalmic improvement [20 weeks]
- Change from baseline in the Gorman Score for diplopia [20 weeks]
- Change from baseline in the Graves' Ophthalmopathy Quality of Life (GO-QOL) [20 weeks]
- Proportion of patients with Clinical Activity Score (CAS) of 0 or 1 [20 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female ≥ 18 years of age.
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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).
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Onset of active GO within 9 months of screening.
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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.
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Other, more specific inclusion criteria are defined in the protocol
Exclusion Criteria:
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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.
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Use of rituximab, tocilizumab, or any monoclonal antibody for immunomodulation within the past 9 months prior to Baseline.
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Total IgG level < 6g/L at Screening.
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Absolute neutrophil count <1500 cells/mm3 at Screening.
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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.
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Previous orbital irradiation or surgery for GO.
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Other, more specific exclusion criteria are defined in the protocol
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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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.- RVT-1401-2001