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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1308-4718 | Other Identifier | WHO Universal Trial Number (UTN) | |
| 2024-514801-69-00 | Other Identifier | EU CTN |
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Phase 2b trial of TOUR006 in Thyroid Eye Disease (TED) to evaluate 20mg and 50mg doses against placebo given by a subcutaneous injection every eight weeks to TED patients who are in the active inflammatory phase of disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TOUR006 - 20 MG | Experimental | In part A of the study, participants will receive a total of three 20 mg subcutaneous injections: 1 injection every 8 weeks (Day 1, Week 8, Week 16) followed by treatment in part B of the study based on proptosis response and rescue therapy use. |
|
| TOUR006 - 50 MG | Experimental | In part A of the study, participants will receive a total of three 50 mg subcutaneous injections: 1 injection every 8 weeks (Day 1, Week 8, Week 16) followed by treatment in part B of the study based on proptosis response and rescue therapy use. |
|
| Placebo | Placebo Comparator | In part A of the study, participants will receive a total of three Placebo subcutaneous injections: 1 injection every 8 weeks (Day 1, Week 8, Week 16) followed by treatment in part B of the study based on proptosis response and rescue therapy use. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TOUR006 - 20 MG | Drug | TOUR006 20 MG |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants achieving a proptosis response defined as a ≥2 mm reduction in proptosis from baseline in the study eye without deterioration [≥2 mm increase] of proptosis in the fellow eye and without need for rescue therapy/intervention). | 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants achieving a proptosis response with 20mg TOUR006 administered SC every 8 weeks or 50mg TOUR006 administered SC every 8 weeks. | 72 weeks | |
| Percentage of participants attaining a complete or near complete response on the 7-point Clinical Activity Score (CAS). |
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Inclusion Criteria:
Additional inclusion criteria are defined in the study protocol.
Exclusion Criteria:
Additional exclusion criteria are defined in the study protocol.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Tourmaline Bio | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catalina Eye Care - Site 840-121 | Tucson | Arizona | 85712 | United States | ||
| Foothill Eye Institute - Site 840-116 |
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| Other |
Placebo |
|
| TOUR006 - 50 MG | Drug | TOUR006 - 50 MG |
|
| 72 weeks |
| Percentage of participants attaining ≥1 grade decrease in diplopia. | 72 weeks |
| Incidence of Treatment Emergent Adverse Events by severity and Serious Adverse Events through Week 72. | 72 weeks |
| Mean change from baseline in serum trough concentration of TOUR006. | 72 weeks |
| Mean change from baseline in serum TSI. | 72 weeks |
| Percentage of participants with anti-drug antibodies. | 72 weeks |
| Pasadena |
| California |
| 91107 |
| United States |
| University of California Davis Eye Center - Site 840-119 | Sacramento | California | 95817 | United States |
| The Pacific Center for Oculofacial and Aesthetic Plastic Surgery - Site 840-122 | San Francisco | California | 94115 | United States |
| UC Hospital Sue Anschulz-Rodgers Eye Center - Site 840-101 | Aurora | Colorado | 80045 | United States |
| Bascom Palmer Eye Institute - Site 840-115 | Miami | Florida | 33136 | United States |
| Ophthalmic Consultants of Boston - Site 840-128 | Boston | Massachusetts | 02114 | United States |
| Kahana Oculoplastic and Orbital Surgery - Site 840-112 | Livonia | Michigan | 48152 | United States |
| Ophthalmic Plastic, Reconstructive, Orbital & Cosmetic Surgery - Site 840-123 | Las Vegas | Nevada | 89144 | United States |
| Hackensack University Medical Center - Site 840-105 | Hackensack | New Jersey | 07601 | United States |
| Columbia University - Site 840-125 | New York | New York | 10032 | United States |
| Academy of Diabetes, Thyroid, and Endocrine - Site 840-129 | El Paso | Texas | 79935 | United States |
| DCT Fort Worth Research Center - Site 840-133 | Fort Worth | Texas | 76132 | United States |
| Sun Research Institute - Site 840-120 | San Antonio | Texas | 78215 | United States |
| University of West Virginia - Site 840-113 | Morgantown | West Virginia | 26506 | United States |
| Freire Pesquisa Clinica - Site 076-773 | Belo Horizonte | 13334-290 | Brazil |
| UFG - Hospital de Clinicas da Universidade Federal de Goias - Site 076-762 | Goiânia | 74605-050 | Brazil |
| Santa Casa de Misericordia de Porto Alegre - Site 076-767 | Porto Alegre | 90020-090 | Brazil |
| Universidade Federal do Rio Grande do Sul (UFRGS) - Site 076-775 | Porto Alegre | 90410-000 | Brazil |
| NPCRS - Nucleo de Pesquisa Clinica do Rio Grande do Sul - Site 076-764 | Porto Alegre | 90430-001 | Brazil |
| Centro Brasileiro de Pesquisa Clínica - Rio de Janeiro Ltd - Site 076-765 | Rio de Janeiro | 22410-000 | Brazil |
| Irmandade da Santa Casa de Misericordia de Sao Paulo - Site 076-771 | São Paulo | 01221-020 | Brazil |
| IPEPO - Instituto Paulista de Estudos e Pesquisas em Oftalmologia - Site 076-761 | São Paulo | 04038-032 | Brazil |
| CHU Angers - Site 250-252 | Angers | 49933 | France |
| CHU de Nantes - Hopital Nord Laennec - Site 250-251 | Nantes | 44800 | France |
| Azienda Ospedaliera Universitaria Federico II - Site 390-382 | Naples | 80131 | Italy |
| Azienda Ospedaliero Universitaria Pisana - Site 380-381 | Pisa | 56124 | Italy |
| Al-Essra Hospital - Site 400-401 | Amman | Jordan |
| Riga East Clinical University Hospital, Clinic Bikernieki - Site 428-901 | Riga | LV1006, Latvia | Latvia |
| Ziemelkurzemes Regional Hospital - Site 428-902 | Ventspils | Latvia |
| Southern Eye Specialists Ltd - Site 554-501 | Christchurch | 8013 | New Zealand |
| University of Puerto Rico, Medical Sciences Campus - Site 630-602 | San Juan | 00921 | Puerto Rico |
| Univerzitna nemocnica Bratislava - Nemocnica sv. Cyrila a Metoda - Site 703-211 | Bratislava | 851 07 | Slovakia |
| Seoul National University Hospital - Site 410-002 | Seoul | 03080 | South Korea |
| Hospital Universitario Ramon y Cajal - Site 724-803 | Madrid | 28034 | Spain |
| Hospital Universitario Virgen Macarena - Site 724-801 | Seville | 41009 | Spain |
| ID | Term |
|---|---|
| D049970 | Graves Ophthalmopathy |
| D006111 | Graves Disease |
| D005094 | Exophthalmos |
| D005128 | Eye Diseases |
| D013959 | Thyroid Diseases |
| D006980 | Hyperthyroidism |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D009916 | Orbital Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006042 | Goiter |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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