A Study to Investigate Efficacy and Safety of TOUR006 in Participants 18 to 75 Years of Age With Thyroid Eye Disease (spiriTED)
Thyroid Eye Disease
About this trial
This is an interventional treatment trial for Thyroid Eye Disease focused on measuring TED, Graves' Disease, Thyroid Eye Disease, Exophthalmos, Eye Diseases, Thyroid Diseases, Graves' Ophthalmopathy, Hyperthyroidism
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of Graves' disease associated with moderate to severe active TED Onset of active TED symptoms within approximately 12 months Proptosis (exophthalmos) ≥3 mm above the normal range (based upon race and gender) for the study eye CAS ≥4 (on the 7-item scale) for the study eye Presence of thyroid stimulating immunoglobulin (TSI) above the upper limit of normal 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 steroid (oral or IV) 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 <1 g methylprednisolone (or equivalent dosage for other systemic corticosteroid) for the treatment of TED is allowed if the corticosteroid is discontinued at least 6 weeks before screening. Systemic (oral or IV) corticosteroid use for conditions other than TED within 3 months before screening. 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.
Sites / Locations
- Site - 0103Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
TOUR006 - 20 MG
TOUR006 - 50 MG
Placebo
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.
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.
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.