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A Phase 3b/4, Double-masked, randomized, International, Parallel-assignment, Multicenter Trial in Patients with Thyroid Eye Disease to Evaluate the Safety and Tolerability of Different Dosing Durations of Teprotumumab Protocol Number: HZNP-TEP-402

Study category: Eyes

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Patients are “randomized” (assigned by chance) to receive one of the following study treatment lengths: • 4 infusions of TEPEZZA (teprotumumab) (Cohort [Group] 1), followed by either 4 infusions of TEPEZZA or 4 infusions of placebo (Placebo looks like the study drug, but does not include the active ingredient found in TEPEZZA. ) or • 8 infusions of TEPEZZA (Cohort 2) or • 16 infusions of TEPEZZA (Cohort 3)

Main Procedures Involved: Study drug infusion, blood draws, and eye measurements

Duration of Participation: Initial treatment is 24-48 weeks with an additional 1 year of follow-up


18 to 80 years


Ages 18-80 Diagnosis of thyroid eye disease within 7 years of Screening Proptosis (bulging of eyes) greater than/equal to 3mm from baseline Must be euthryoid No prior eye muscle surgery, decompression surgery, or treatment with TEPEZZA

Type of Study



Compensation Provided

Travel Compensation

Travel Compensation Provided


University of Colorado Hospital

Principal Investigator
Prem Subramanian,  MD, PhD

Prem Subramanian, MD, PhD

Study ID

Protocol Number: 21-3831

More information available at NCT05002998

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