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This is a clinical trial assessing the safety and tolerability of an investigational drug, VRDN-003, in participants with 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), controlled study that will include participants with TED of any duration. The key objectives of this study are to determine if VRDN-003 is safe and tolerable when administered as a series of subcutaneous (SC) injections every 4 weeks or every 8 weeks in participants with TED.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VRDN-003 every 4 weeks | Experimental | 6 subcutaneous administrations of VRDN-003 |
|
| VRDN-003 every 8 weeks | Experimental | 3 subcutaneous administrations of VRDN-003 and 3 subcutaneous administrations of placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VRDN-003 | Drug | VRDN-003 is an investigational, subcutaneously administered, humanized monoclonal antibody directed against the Insulin-like Growth Factor-1 receptor (IGF-1R). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Emergent Adverse Event (TEAE) incidence rate through Week 24 | Treatment Emergent Adverse Event (TEAE) incidence rate through Week 24 | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in proptosis in the study eye at Week 24 as measured by exophthalmometer | Change from baseline in proptosis in the study eye | Week 24 |
| TEAE incident rate through study completion |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catalina Eye Care | Tuscon | Arizona | 85712 | United States | ||
| United Medical Research Institute |
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Participants will be randomized to one of the two study arms.
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Participant, Site personnel (except pharmacy personnel preparing the injection), and Sponsor are masked.
| Placebo | Drug | Placebo injections that appear identical to VRDN-003 injections but have no active drug. |
|
Treatment Emergent Adverse Event (TEAE) incidence rate measurement through study completion
| Week 52 |
| Inglewood |
| California |
| 90301 |
| United States |
| Orbital Plastics | Newport Beach | California | 92660 | United States |
| California Eye Specialists Medical Group INC | Pasadena | California | 91107 | United States |
| FOMAT Medical Research | Pismo Beach | California | 93030 | United States |
| Pacific Neuroscience Institute | Santa Monica | California | 90404 | United States |
| Pacific Neuroscience Institute at Saint John's Physician Partners | Torrance | California | 90503 | United States |
| C A Clinical Trial Corp. | Cape Coral | Florida | 33990 | United States |
| Herco Medical and Research Center | Coral Gables | Florida | 33134 | United States |
| Alfa Medical Research | Davie | Florida | 33024 | United States |
| D H Doral Research Center | Doral | Florida | 33132 | United States |
| Eye Centers of Florida | Fort Myers | Florida | 33901 | United States |
| Sina Medical Center | Homestead | Florida | 33034 | United States |
| East Coast Institute for Research, LLC | Jacksonville | Florida | 32216 | United States |
| Southern Clinical Research LLC | Miami | Florida | 33125 | United States |
| Retreat Medical Research | Miami | Florida | 33135 | United States |
| Continental Clinical Research | Miami | Florida | 33144 | United States |
| Edward Jenner Research Group LLC | Plantation | Florida | 33317 | United States |
| Sarasota Retina Institute | Sarasota | Florida | 34239 | United States |
| Advanced Quality Medical Research | Orland Park | Illinois | 60462 | United States |
| Ophthalmic Consultants of Boston | East Weymouth | Massachusetts | 02189 | United States |
| Fraser Eye Care Center | Fraser | Michigan | 48026 | United States |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | United States |
| University of Missouri Kansas City | Kansas City | Missouri | 64108 | United States |
| Rutgers New Jersey Medical School | Newark | New Jersey | 07103 | United States |
| Jackson Clinic | Jackson | Tennessee | 38305 | United States |
| DFW Clinical Trials | Carrollton | Texas | 75010 | United States |
| Neuro Eye Clinical Trials | Houston | Texas | 77074 | United States |
| Pioneer Research Solutions Inc. | Houston | Texas | 77099 | United States |
| San Antonio Clinical Trials | San Antonio | Texas | 78240 | United States |
| Eyeplastx | San Antonio | Texas | 78258 | United States |
| Elevate Clinical Research | Seabrook | Texas | 77586 | United States |
| Servicde d'Endocrinologie, Diabetologieet Nutrition Centre Hospitalier Universitaire d'Angers | Angers | France |
| Abeillon du Payrat | Bron | 69500 | France |
| Hôpital La Pitiélsalpêtrière | Paris | France |
| Charite Universitatsmeizin Berlin KoR Campus Virchow Klinikum | Berlin | Germany |
| Universitatsklinikum Essen | Essen | Germany |
| Universitaetsmedizin Goettingen | Göttingen | 37075 | Germany |
| Johannes Gutenberg University Medical Center Department of Medicine 1 | Mainz | Germany |
| Uniwersytecki Szpital Kliniczny w Białymstoku, Klinika Okulistyki, Centrum Badań Klinicznych | Bialystok | 15-276 | Poland |
| Optimum Profesorskie Centrum Okulistyki Sp. z o. o. | Gdansk | 80-180 | Poland |
| Centrum Medyczne Pratia Gdynia | Gdynia | 81-338 | Poland |
| Santa Familia PTG Lodz | Lodz | 90-302 | Poland |
| ETG Lublin | Lublin | 20-412 | Poland |
| Centrum Medyczne Pulawska Sp. z o.o. | Piaseczno | 05-500 | Poland |
| Warszawski Szpital Okulistyczny | Warsaw | 01-258 | Poland |
| Polimedica PTG | Warsaw | 02-777 | Poland |
| Hospital Provincial de Conxo | A Coruña | 15706 | Spain |
| Institut Català de Retina | Barcelona | 08017 | Spain |
| Hospital La Arruzafa | Córdoba | 14012 | Spain |
| Hospital Universitario Ramon y Cajal | Madrid | 28034 | Spain |
| Clinica Universidad de Navarre | Navarrés | Spain |
| Hospital Universitario Virgen Macarena | Seville | 41009 | Spain |
| Hospital Universitario Miguel Servet Consultas de Oftalmologia | Zaragoza | Spain |
| Gazi University Medical Faculty Hospital | Ankara | Turkey (Türkiye) |
| Hacettepe Univeristy Medical Fculty Hospital | Ankara | Turkey (Türkiye) |
| Akdeniz Üniversitesi Tıp Fakültesi Göz Hastalıkları Anabilim Dalı | Antalya | 07059 | Turkey (Türkiye) |
| Marmara Üniversitesi Pendik Eğitim ve Araştırma Hastanesi Göz Hastalıkları Kliniği | Istanbul | Turkey (Türkiye) |
| University Hospitals Bristol and Weston NHS Foundation Trust Clinical Research Unit | Bristol | United Kingdom |
| Addenbrookes Hospital | Cambridge | United Kingdom |
| Imperial College Healthcare NHS Trust | London | NW1 5QH | United Kingdom |
| Guy's and St Thomas' NHS Foundation Trust | London | SE1 7EH | United Kingdom |
| Moorefields Eye Hospital NHS Foundation Trust | London | United Kingdom |
| The Newcastle Upon Tyne Hospitals NHS Foundation Trust | Newcastle | United Kingdom |
| ID | Term |
|---|---|
| D049970 | Graves Ophthalmopathy |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D006111 | Graves Disease |
| 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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