Last updated 29 days ago
A Study to Investigate Efficacy and Safety of TOUR006 in Participants 18 to 80 Years of Age With Thyroid Eye Disease
81 patients around the world
Available in Puerto Rico, United States, Brazil
Tourmaline Bio, Inc.
8Research sites
81Patients around the world
This study is for people with
Thyroid Disease
Thyroid Eye Disease
Requirements for the patient
To 80 Years
All Gender
Medical requirements
- 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.
- 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.
Sites
Freire Pesquisa Clínica
Recruiting
Hospital das Clínicas da Universidade Federal de Goiás - UFG
Recruiting
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Recruiting
Universidade Federal do Rio Grande do Sul
Recruiting
Núcleo de Pesquisa Clínica do Rio Grande do Sul - NPCRS
Recruiting
Irmandade da Santa Casa de Misericórdia de São Paulo - Hospital Central
Recruiting
Vision Institute - IPEPO (IPEPO - Instituto da Visão - Vila Clementino)
Recruiting
Universidad de Puerto Rico - Recinto de Río Piedras
Recruiting
StudyspiriTED
SponsorTourmaline Bio, Inc.
Study typeInterventional
Conditions
Thyroid Eye Disease
Requirements
To 80 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06088979
