An Open-Label Trial of Veligrotug in Participants With Thyroid Eye Disease Who Previously Responded to Teprotumumab

This is a Phase 4, single-arm, open-label (meaning study doctor, participant and the sponsor will know which study arm participant is assigned to) clinical trial to evaluate the safety and efficacy of veligrotug (LUMVOA™) in participants with moderate to severe TED who previously received and responded to an initial course of teprotumumab but subsequently had disease recurrence.

The primary objective of this trial is to evaluate the safety and tolerability of veligrotug when given as 5 intravenous (IV) infusions of 10 mg/kg administered every 3 weeks. To evaluate safety, the incidence rate of treatment-emergent adverse events (TEAEs) 3 weeks after the fifth infusion (ie, Week 15) will be determined.

Key Inclusion Criteria:

• Must have a diagnosis of TED with associated signs and symptoms.
• Must have completed an initial full course of treatment (8 infusions over approximately 21 weeks) with teprotumumab ≥9 months prior to screening.
• Must have a documented clinical response to teprotumumab.
• Must have evidence of recurrence following the completion of prior teprotumumab treatment course, as measured by exophthalmometer in the study eye.
• Must have a Clinical Activity Score (CAS) ≥3 in the study eye.
• Must not require immediate orbital surgery in the study eye during the anticipated duration of the trial.
• Must agree to use highly effective contraception as specified in the protocol.
• Female TED participants must have a negative serum pregnancy test at screening.

Key Exclusion Criteria:

• Must not have sight-threatening TED (eg, dysthyroid optic neuropathy).
• Must not have received IGF-1R inhibitor therapy within 9 months prior to screening or received any IGF-1R inhibitor other than teprotumumab at any time.
• Must not have received systemic corticosteroids or steroid eye drops for any condition, including TED, or selenium within 2 weeks prior to the first dose.
• Must not have received other immunosuppressive drugs for any condition, including TED, within 12 weeks prior to the first dose or any other therapy for TED (except for artificial tears) within 8 weeks prior to the first dose.
• Must not have received radioactive iodine (RAI) treatment within 8 weeks prior to first dose.
• Must not have previous orbital irradiation or decompression surgery for TED to the study eye's orbit.
• Must not have a pre-existing ophthalmic condition in the study eye which, in the study doctor's opinion, would interfere with interpretation of trial results.
• Must not have abnormal hearing test before first dose or any history of hearing impairment. Must not also have any history of ear conditions considered significant by the study doctor.
• Must not have a history of inflammatory bowel disease.
• Female participants must not be pregnant or breastfeeding.