Last updated 9 days ago
A Trial to Investigate Teprotumumab Subcutaneous Administration Compared With Placebo in Male and Female Adult Participants With Moderate-to-severe Active Thyroid Eye Disease
80 patients around the world
Available in Argentina
The main objective of the study is to evaluate the effect of teprotumumab subcutaneous
administration versus placebo on the proptosis responder rate (ie, the percentage of
participants with a ≥ 2-mm reduction from Baseline in the study eye without deterioration
[≥ 2-mm increase] of proptosis in the fellow eye) at Week 24.
Acquired from Horizon in 2024.
Amgen
1Research sites
80Patients around the world
This study is for people with
Thyroid Disease
Thyroid Eye Disease
Requirements for the patient
To 80 Years
All Gender
Medical requirements
- Participant must provide written informed consent.Participant can be male or female and must be between the ages of 18 and 80 years, inclusive, at Screening.Participant must have a clinical diagnosis of Graves' disease associated with active TED with a CAS ≥ 3 for the most severely affected eye at Screening and Baseline.Participant must have moderate-to-severe active TED, usually associated with 1 or more of the following: lid retraction ≥ 2 mm, moderate or severe soft tissue involvement and/or inconstant or constant diplopia.Participant has proptosis ≥ 3 mm from Baseline, as estimated by treating physician, and/or proptosis ≥ 3 mm above normal for race and gender.Participant had onset of active TED symptoms within 15 months prior to Baseline.Participants must be euthyroid with the baseline disease under control or have mild hypo- or hyperthyroidism at Screening.Participant does not require immediate surgical ophthalmological intervention and is not planning corrective surgery/irradiation during the trial.Women of childbearing potential must have a negative serum pregnancy test at Screening and negative urine pregnancy tests at all protocol-specified time points.Participant is willing and able to comply with the protocol requirements for the duration of the trial.
- Participant has decreased best-corrected visual acuity due to optic neuropathy, defined by a decrease in vision of 2 lines on the Snellen chart, new visual field defect or color defect secondary to optic nerve involvement within the last 6 months.Participant has corneal decompensation unresponsive to medical management.Participant has a decrease in CAS of ≥ 2 points between Screening and Baseline.Participant has a decrease in proptosis of ≥ 2 mm between Screening and Baseline.Participant had prior orbital irradiation, orbital decompression or strabismus surgery excluding childhood strabismus surgeries unrelated to TED/Graves' disease.Participant is planning to have eyelid surgery during the trial.Participant received periocular botulinum toxin injection within 12 months prior to Screening.Participant has any systemic use of a steroid for the treatment of TED or other conditions within 3 weeks prior to Screening.
Sites
Organización Médica de Investigación (OMI)
Recruiting
SponsorAmgen
Conditions
Thyroid Eye Disease
Requirements
To 80 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06248619
