TEPEZZA® (Teprotumumab-trbw) Post-Marketing Requirement Study (NCT05002998) | Clinical Trial Compass
CompletedPhase 4
TEPEZZA® (Teprotumumab-trbw) Post-Marketing Requirement Study
United States313 participantsStarted 2021-09-16
Plain-language summary
This is a double-masked, randomized, parallel-assignment, multicenter trial examining the safety and tolerability of teprotumumab in the treatment of Thyroid Eye Disease (TED) in adult participants. This international, Phase 3b/4 trial is being conducted to fulfill an FDA post-marketing requirement for a descriptive trial to evaluate the safety, efficacy and need for re-treatment of 3 different teprotumumab treatment durations for TED. In addition, serum samples from participants with a Baseline Clinical Activity Score (CAS) ≥3 will be evaluated for biomarkers of disease.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Written informed consent.
✓. Male or female between the ages of 18 and 80 years, inclusive, at Screening.
✓. Initial diagnosis of TED within 7 years prior to Screening.
✓. Proptosis ≥3 mm from baseline (prior to diagnosis of TED), as estimated by treating physician, and/or proptosis \>3 mm above normal for race and gender.
✓. Participants must be euthyroid with the baseline disease under control or have mild hypo or hyperthyroidism (defined as free thyroxine and free triiodothyronine levels \<50% above or below the normal limits) at Screening. Every effort should be made to correct the mild hypo- or hyperthyroidism promptly and to maintain the euthyroid state for the duration of the trial.
✓. Does not require immediate surgical ophthalmological intervention and is not planning corrective surgery/irradiation during the course of the trial.
✓. Diabetic participants must have HbA1c ≤8.0% at Screening.
✓. Participants with a history of IBD (ulcerative colitis or Crohn's disease) must be in clinical remission for at least 3 months, with no history of bowel surgery within 6 months prior to Screening and no planned surgery during the trial. Concomitant stable therapies for IBD without modifications in the 3 months prior to Screening are allowed.
Exclusion criteria
✕. Decreased best-corrected visual acuity due to optic neuropathy, as 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.
What they're measuring
1
Percentage of Participants who experience at least 1 treatment-emergent adverse event (TEAE) and the percentage of participants who experience at least 1 treatment emergent AESI during treatment with teprotumumab
Timeframe: Screening to End of Study (last visit possible is Week 136)
2
Percentage of Participants who receive re-treatment
✕. Corneal decompensation unresponsive to medical management.
✕. Decrease in proptosis of ≥2 mm in the study eye between Screening and Baseline.
✕. Prior orbital irradiation, orbital decompression or strabismus surgery.
✕. Planned eyelid surgery during the course of the trial.
✕. Alanine aminotransferase or aspartate aminotransferase \>3 × the upper limit of normal or estimated glomerular filtration rate ≤30 mL/min/1.73m2 at Screening.
✕. Use of any steroid (intravenous \[IV\], 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, as well as steroids used to treat infusion reactions.
✕. Any treatment with rituximab (Rituxan® or MabThera®) within 12 months prior to the first infusion of teprotumumab or tocilizumab (Actemra® or Roactemra®) within 6 months prior to the first infusion of teprotumumab. Use of any other non-steroid immunosuppressive agent within 3 months prior to the first infusion of teprotumumab.