Treatment of Graves' Orbitopathy (Thyroid Eye Disease) to Reduce Proptosis With Teprotumumab Infu… (NCT03298867) | Clinical Trial Compass
CompletedPhase 3
Treatment of Graves' Orbitopathy (Thyroid Eye Disease) to Reduce Proptosis With Teprotumumab Infusions in a Randomized, Placebo-Controlled, Clinical Study
United States83 participantsStarted 2017-10-04
Plain-language summary
The overall objective is to investigate the efficacy, tolerability, and safety of teprotumumab (a fully human monoclonal antibody \[mAb\] inhibitor of the insulin-like growth factor-1 receptor \[IGF-1R\]) administered once every 3 weeks (q3W) for 21 weeks with a final assessment at Week 24, in comparison to placebo, in the treatment of participants with moderate-to-severe active thyroid eye disease (TED).
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Written informed consent.
✓. Male or female participant between the ages of 18 and 80 years, inclusive, at Screening.
✓. Clinical diagnosis of Graves' disease associated with active TED with a Clinical Activity Score (CAS) ≥ 4 (on the 7-item scale) for the most severely affected eye at Screening and Baseline.
✓. Moderate-to-severe active TED (not sight-threatening but has an appreciable impact on daily life), usually associated with one or more of the following: lid retraction ≥ 2 mm, moderate or severe soft tissue involvement, exophthalmos ≥ 3 mm above normal for race and gender, and/or inconstant or constant diplopia.
✓. Onset of active TED symptoms (as determined by participant records) within 9 months prior to Baseline.
✓. Participants must be euthyroid with the baseline disease under control or have mild hypo- or hyperthyroidism (defined as free thyroxine \[FT4\] and free triiodothyronine \[FT3\] 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 full duration of the clinical trial.
✓. Does not require immediate surgical ophthalmological intervention and is not planning corrective surgery/irradiation during the course of the study.
✓. Alanine aminotransferase (ALT) or AST ≤ 3 times the upper limit of normal (ULN) or serum creatine \<1.5 times the ULN according to age at Screening.
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 Were Proptosis Responders at Week 24
✕. Corneal decompensation unresponsive to medical management.
✕. Decrease in CAS of ≥ 2 points in the study eye between Screening and Baseline.
✕. Decrease in proptosis of ≥ 2 mm in the study eye between Screening and Baseline.
✕. Previous orbital irradiation or surgery for TED.
✕. Any steroid use (intravenous \[IV\] or oral) with a cumulative dose equivalent to ≥ 1 g of methylprednisolone for the treatment of TED. Previous steroid use (IV or oral) with a cumulative dose of \<1 g methylprednisolone or equivalent for the treatment of TED and previous use of steroid eye drops is allowed if the corticosteroid was discontinued at least 4 weeks prior to Screening.
✕. Corticosteroid use for conditions other than TED within 4 weeks prior to Screening (topical steroids for dermatological conditions and inhaled steroids are allowed).
✕. Selenium and biotin must be discontinued 3 weeks prior to Screening and must not be restarted during the clinical trial; however, taking a multivitamin that includes selenium and/or biotin is allowed.