A Study to Investigate Efficacy and Safety of TOUR006 in Participants 18 to 75 Years of Age With Thyroid Eye Disease

Overview

About this study

The purpose of this study is 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 5/23/2024. Questions regarding updates should be directed to the study team contact.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Marius Stan, M.D.

Open for enrollment

Contact information:

Department of Medicine - Clinical Research Office

(507) 266-1944

DOMResearchHub@mayo.edu

More information

Publications

Publications are currently not available