Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Tourmaline Bio, Inc., a Novartis Company
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
