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This is a clinical trial assessing the efficacy, safety, and tolerability of an investigational drug, veligrotug (VRDN-001), in participants with chronic thyroid eye disease (TED).
This is a randomized (meaning participants will be assigned to study arms by chance), double-masked (meaning study doctor and participant will not know which study arm participant is assigned to), placebo-controlled study that will include participants with chronic TED. The key objectives of this study are to determine if veligrotug (VRDN-001) is efficacious, safe, and tolerable when administered as 5 IV infusions given every 3 weeks for a total of 12 weeks in participants with chronic TED
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Veligrotug (VRDN-001)10 mg/kg | Experimental | Drug: 5 IV Infusions of veligrotug (VRDN-001)10 mg/kg |
|
| Placebo Drug | Experimental | Placebo Drug: 5 IV Infusions of placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Veligrotug (VRDN-001) | Drug | Veligrotug (VRDN-001) is a humanized monoclonal antibody directed against the IGF-1 receptor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proptosis Responder Rate in the most proptotic eye | Proptosis Responder Rate in the most proptotic eye (i.e., reduction of proptosis of ≥2 mm from baseline [without a corresponding increase of ≥2 mm in the other eye]) as measured by exophthalmometer. | Week 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in proptosis in the most proptotic eye | Change from baseline in proptosis in the most proptotic eye as measured by exophthalmometer | Week 15 |
| Proptosis Responder Rate in the most proptotic eye |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advancing Research International, LLC | Los Angeles | California | 90023 | United States | ||
| USC Roski Eye Institute |
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| Placebo | Drug | 5 IV infusions of placebo |
|
Change from baseline in proptosis in the most proptotic eye
| Week 15 |
| Clinical Activity Responder Rate in the most proptotic eye | Clinical Activity Responder Rate in the most proptotic eye (i.e., no worsening in CAS from baseline [without a corresponding increase of ≥2 points in the other eye]) as measured by exophthalmometer | Week 15 |
| Overall Responder Rate in the most proptotic eye | Overall Responder Rate comprised of Proptosis Responder Rate in the most proptotic eye as measured by exophthalmometer and Clinical Activity Responder rate in the most proptotic eye as measured by exophthalmometer | Week 15 |
| Diplopia Responder Rate | Diplopia Responder Rate (i.e., reduction in Gorman Subjective Diplopia Score of ≥1 from baseline for participants with baseline Gorman Subjective Diplopia Score >0) | Week 15 |
| Diplopia Resolution Rate | Diplopia Resolution Rate (i.e., reduction in Gorman Subjective Diplopia Score to 0 from baseline for participants with baseline Gorman Subjective Diplopia Score > 0) | Week 15 |
| Los Angeles |
| California |
| 90089 |
| United States |
| Amy Patel Jain, MD | Newport Beach | California | 92660 | United States |
| Stanford Byers Eye Institute | Palo Alto | California | 94303 | United States |
| Cockerham Eye Consultants, PC | San Diego | California | 92108 | United States |
| Bascom Palmer Eye Institute - Ophthalmology - Miami | Miami | Florida | 33136 | United States |
| Sarasota Retina Institute | Sarasota | Florida | 34239 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Family Eye Physicians, Ltd | Oak Lawn | Illinois | 60453 | United States |
| Massachusetts Eye and Ear | Boston | Massachusetts | 02114 | United States |
| Ophthalmic Consultants of Boston | Boston | Massachusetts | 02189 | United States |
| Michigan State University, Department of Neurology | East Lansing | Michigan | 48824 | United States |
| Kahana Oculoplastic and Orbital Surgery | Livonia | Michigan | 48152 | United States |
| Washington University School of Medicine in St Louis - Ophthalmology | St Louis | Missouri | 63110 | United States |
| Steven Leibowitz, MD. | Las Vegas | Nevada | 89144 | United States |
| Rutgers - New Jersey Medical School | Newark | New Jersey | 07103 | United States |
| The Center for Eye and Facial Plastic Surgery | Somerset | New Jersey | 08873 | United States |
| Department of Ophthalmology, University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Wills Eye Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Baylor College of Medicine (BCM) - Ophthalmology | Houston | Texas | 77030 | United States |
| Neuro Eye Clinical Trials | Houston | Texas | 77074 | United States |
| University of Vermont Medical Center | Burlington | Vermont | 05401 | United States |
| Harborview Medical Center | Seattle | Washington | 98104 | United States |
| North Shore Private Hospital | Saint Leonards | New South Wales | 2065 | Australia |
| CHU Angers | Angers | 49033 | France |
| CHU de Bordeaux - Hôpital Saint-André | Bordeaux | 33000 | France |
| Centre Hospitalier Universitaire De Nantes - G. R. Laennec | Nantes | 44093 | France |
| CH Nice | Nice | 06000 | France |
| Charité - Universitätsmedizin Berlin KöR | Berlin | 13353 | Germany |
| Universitätsklinikum Essen AöR | Essen | 45122 | Germany |
| University Medical Center Freiburg | Freiburg im Breisgau | 79106 | Germany |
| Universitätsmedizin Göttingen | Göttingen | 37075 | Germany |
| Budapest Retina Intezet | Budapest | H-1133 | Hungary |
| Ganglion Orvosi Kozpont | Pécs | H-7621 | Hungary |
| Pecsi Tudomanyegyetem Klinikai Kozpont Szemeszeti Klinika | Pécs | H-7623 | Hungary |
| Uniwersytecki Szpital Kliniczny w Bialymstoku | Bialystok | 15-276 | Poland |
| Oculomedica Sp. z o.o. | Bialystok | 85-157 | Poland |
| Optimum Profesorskie Centrum Okulistyki Sp. z o.o. | Gdansk | 80-809 | Poland |
| Centrum Medyczne Pulawska Sp. z o.o. | Piaseczno | 05-500 | Poland |
| Centrum Medyczne Piasta 47 sp. z o.o. | Wałbrzych | 58-304 | Poland |
| Complexo Hospitalario Universitario de Santiago-Hospital Médico-Cirúrxico de Conxo | A Coruña | 15706 | Spain |
| Centro de Oftalmologia Barraquer (Barraquer Ophthalmology Centre) | Barcelona | 08021 | Spain |
| Hospital La Arruzafa | Córdoba | 14012 | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | 28034 | Spain |
| Hospital Universitario Virgen De La Macarena | Seville | 41009 | Spain |
| Hospital Universitario Virgen del Rocio | Seville | 41013 | Spain |
| Hospital Universitario Y Politécnico La Fe | Valencia | 46026 | Spain |
| Hospital Unviersitario Miguel Servet | Zaragoza | 50009 | Spain |
| Hacettepe Universitesi Tip Fakultesi | Ankara | 06230 | Turkey (Türkiye) |
| Gazi University Medical Faculty Hospital | Ankara | 06500 | Turkey (Türkiye) |
| Akdeniz University Medical Faculty Hospital | Antalya | 07059 | Turkey (Türkiye) |
| Marmara University Faculty of Medicine | Istanbul | 34854 | Turkey (Türkiye) |
| Moorfield's Eye Hospital | London | EC1V 2PD | United Kingdom |
| Imperial College Healthcare NHS Trust - Western eye Hospital | London | NW1 5QH | United Kingdom |
| Guy's and St. Thomas NHS Trust | London | SE1 7EH | United Kingdom |
| The Newcastle Upon Tyne Hospitals NHS Foundation Trust | Newcastle | NEI 4LP | United Kingdom |
| University Hospital Southampton NHS Foundation Trust | Southampton | SO16 6YD | United Kingdom |
| ID | Term |
|---|---|
| D049970 | Graves Ophthalmopathy |
| D006111 | Graves Disease |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D005094 | Exophthalmos |
| D009916 | Orbital Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006042 | Goiter |
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
| D006980 | Hyperthyroidism |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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