A Study Evaluating TEPEZZA® Treatment in Patients With Chronic (Inactive) Thyroid Eye Disease (NCT04583735) | Clinical Trial Compass
CompletedPhase 4
A Study Evaluating TEPEZZA® Treatment in Patients With Chronic (Inactive) Thyroid Eye Disease
United States62 participantsStarted 2021-09-02
Plain-language summary
The overall objective is to investigate the efficacy, safety and tolerability of TEPEZZA® in participants with chronic (inactive) TED (thyroid eye disease). Approximately 57 participants will be enrolled. There will be a treatment period (through Week 24) and a follow up period (where TEPEZZA will not be infused).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Written informed consent.
✓. Male or female at least 18 years old at Screening.
✓. Initial diagnosis of TED ≥2 years but \<10 years prior to Screening. Clinical diagnosis of stable, chronic (inactive) TED, as determined by participant medical records indicating a Clinical Activity Score (CAS) ≤1 in both eyes for at least 1 year prior to Screening or all of the following:
✓. no progression in proptosis for at least 1 year prior to Screening
✓. if participant has history of diplopia due to TED, no progression in diplopia for at least 1 year prior to Screening
✓. no new inflammatory TED symptoms for at least 1 year prior to Screening
✓. CAS ≤1 at the Screening and Baseline Visits.
✓. Proptosis ≥3-mm increase from participant's Baseline (prior to diagnosis of TED), as estimated by treating physician and/or proptosis ≥3 mm above normal for race and gender.
Exclusion criteria
✕. 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.
✕. Corneal decompensation unresponsive to medical management in the study eye
✕. Decrease in proptosis of ≥2 mm in the study eye between Screening and Baseline.
What they're measuring
1
Change From Baseline in Proptosis of Study Eye at Week 24
✕. Prior orbital irradiation, orbital decompression in the study eye.
✕. Prior strabismus surgery.
✕. Alanine aminotransferase or aspartate aminotransferase \>3 × the upper limit of normal or estimated glomerular filtration rate ≤30 mL/min/1.73 m2 at Screening.
✕. Use of any steroid (IV, oral, steroid eye drops) for the treatment of TED or other conditions within 3 weeks prior to Screening. Steroids cannot be initiated during the trial. Exceptions include topical and inhaled steroids and steroids used to treat infusion reactions.
✕. Any treatment with rituximab (Rituxan® or MabThera®) within 12 months prior to the first infusion of trial drug or tocilizumab (Actemra® or Roactemra®) within 6 months prior to the first infusion of trial drug. Use of any other non-steroid immunosuppressive agent within 3 months prior to the first infusion of trial drug.