Clinical Trials in Italy / NCT06088979
Active, not recruiting
Phase 2
A Study to Investigate Efficacy and Safety of TOUR006 in Participants 18 to 80 Years of Age With Thyroid Eye Disease
NCT06088979 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Thyroid Eye Disease
Investigational drug(s) / intervention(s)
TOUR006 - 20 MGPlaceboTOUR006 - 50 MG
TOUR006 - 20 MG: TOUR006 20 MG
Placebo: Placebo
TOUR006 - 50 MG: TOUR006 - 50 MG
Study summary
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.
Eligibility
Inclusion Criteria:
* Clinical diagnosis of Graves' disease associated with moderate to severe active TED
* Onset of active TED symptoms within approximately 15 months
* Proptosis (exophthalmos) ≥3 mm above the normal range per investigator judgment (based upon race and gender) for the study eye
* CAS ≥4 (on the 7-item scale) for the study eye
* Presence of TSI \>130% of the normal reference standard or \>0.55 IU/L (depending on assay method) and laboratory reference ranges
Additional inclusion criteria are defined in the study protocol.
Exclusion Criteria:
* Anticipated need for intervention due to sight-threatening complications or other significant and acute deterioration in vision
* Any previous treatment with teprotumumab or other agent that inhibits the IGF-1 receptor
* History of systemic (eg, oral or IV) steroid use with a cumulative dose equivalent to \>1 g of methylprednisolone for the treatment of TED. Previous oral steroid use with a cumulative dose of ≤1g methylprednisolone (or equivalent dosage for other systemic corticosteroid) for the treatment of TED, however, is allowed if the corticosteroid was discontinued at least 6 weeks before baseline (Day 1) and completely tapered by Baseline (if applicable).
* Systemic (oral or IV) corticosteroid use for conditions other than TED within 6 weeks of baseline (Day 1) or not completely tapered by baseline (if applicable).
* Any major illness/condition or evidence of an unstable clinical condition that, in the investigator's judgment, will substantially increase the risk to the participant, or confound the interpretation of safety assessments, if they were to participate in the study
* Any other condition that, in the opinion of the investigator, would impair the ability of the participant to comply with the study procedures or impair the ability to interpret data from the participant's participation in the study
* Pregnant or lactating
Additional exclusion criteria are defined in the study protocol.
Primary outcome measure(s)
- 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
Trial sites (36)
| Facility | City | Region | Status |
|---|---|---|---|
| Catalina Eye Care - Site 840-121 | Tucson | Arizona | |
| Foothill Eye Institute - Site 840-116 | Pasadena | California | |
| University of California Davis Eye Center - Site 840-119 | Sacramento | California | |
| The Pacific Center for Oculofacial and Aesthetic Plastic Surgery - Site 840-122 | San Francisco | California | |
| UC Hospital Sue Anschulz-Rodgers Eye Center - Site 840-101 | Aurora | Colorado | |
| Bascom Palmer Eye Institute - Site 840-115 | Miami | Florida | |
| Ophthalmic Consultants of Boston - Site 840-128 | Boston | Massachusetts | |
| Kahana Oculoplastic and Orbital Surgery - Site 840-112 | Livonia | Michigan | |
| Ophthalmic Plastic, Reconstructive, Orbital & Cosmetic Surgery - Site 840-123 | Las Vegas | Nevada | |
| Hackensack University Medical Center - Site 840-105 | Hackensack | New Jersey | |
| Columbia University - Site 840-125 | New York | New York | |
| Academy of Diabetes, Thyroid, and Endocrine - Site 840-129 | El Paso | Texas | |
| DCT Fort Worth Research Center - Site 840-133 | Fort Worth | Texas | |
| Sun Research Institute - Site 840-120 | San Antonio | Texas | |
| University of West Virginia - Site 840-113 | Morgantown | West Virginia | |
| Freire Pesquisa Clinica - Site 076-773 | Belo Horizonte | Brazil | |
| UFG - Hospital de Clinicas da Universidade Federal de Goias - Site 076-762 | Goiânia | Brazil | |
| Santa Casa de Misericordia de Porto Alegre - Site 076-767 | Porto Alegre | Brazil | |
| Universidade Federal do Rio Grande do Sul (UFRGS) - Site 076-775 | Porto Alegre | Brazil | |
| NPCRS - Nucleo de Pesquisa Clinica do Rio Grande do Sul - Site 076-764 | Porto Alegre | Brazil | |
| Centro Brasileiro de Pesquisa Clínica - Rio de Janeiro Ltd - Site 076-765 | Rio de Janeiro | Brazil | |
| Irmandade da Santa Casa de Misericordia de Sao Paulo - Site 076-771 | São Paulo | Brazil | |
| IPEPO - Instituto Paulista de Estudos e Pesquisas em Oftalmologia - Site 076-761 | São Paulo | Brazil | |
| CHU Angers - Site 250-252 | Angers | France | |
| CHU de Nantes - Hopital Nord Laennec - Site 250-251 | Nantes | France | |
| Azienda Ospedaliera Universitaria Federico II - Site 390-382 | Naples | Italy | |
| Azienda Ospedaliero Universitaria Pisana - Site 380-381 | Pisa | Italy | |
| Al-Essra Hospital - Site 400-401 | Amman | Jordan | |
| Riga East Clinical University Hospital, Clinic Bikernieki - Site 428-901 | Riga | Latvia | |
| Ziemelkurzemes Regional Hospital - Site 428-902 | Ventspils | Latvia | |
| Southern Eye Specialists Ltd - Site 554-501 | Christchurch | New Zealand | |
| University of Puerto Rico, Medical Sciences Campus - Site 630-602 | San Juan | Puerto Rico | |
| Univerzitna nemocnica Bratislava - Nemocnica sv. Cyrila a Metoda - Site 703-211 | Bratislava | Slovakia | |
| Seoul National University Hospital - Site 410-002 | Seoul | South Korea | |
| Hospital Universitario Ramon y Cajal - Site 724-803 | Madrid | Spain | |
| Hospital Universitario Virgen Macarena - Site 724-801 | Seville | Spain |
Other trials for the same condition
A Trial to Investigate Teprotumumab Subcutaneous Administration Compared With Placebo in Male and Female Adult Participants With Moderate-to-severe Active Thyroid Eye Disease
Active, not recruiting
A Study of AMG 732 in Healthy Participants and Participants With Thyroid Eye Disease
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06088979 on ClinicalTrials.gov ↗ ← All trials in Italy