A Trial to Investigate Teprotumumab Subcutaneous Administration Compared With Placebo in Male and… (NCT06248619) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Trial to Investigate Teprotumumab Subcutaneous Administration Compared With Placebo in Male and Female Adult Participants With Moderate-to-severe Active Thyroid Eye Disease
United States, Argentina, Australia89 participantsStarted 2024-07-05
Plain-language summary
The study consists of a randomized double-masked, placebo-controlled, parallel-group, multicenter trial with an optional open-label treatment period for proptosis non-responders who complete the Double-masked Treatment Period.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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 (on the 7-item scale) for the most severely affected eye at Screening and Baseline.
. Participant must have moderate-to-severe active TED (not sight-threatening but has an appreciable impact on daily life), 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. (Note: Participants with no diplopia at Baseline will be limited to approximately 25% of the total number enrolled.)
. Participant has 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing teprotumumab given as a subcutaneous injection rather than the IV infusion that's already FDA-approved — does that difference in how it's delivered matter for my specific situation, and is it worth discussing whether I might be a candidate for the approved IV version instead?
2The main thing this trial is measuring is whether the eye bulging — proptosis — reduces by at least 2 millimeters; given where my proptosis currently stands, is that level of improvement meaningful for my quality of life and vision?
3Since this is a Phase 3 trial comparing the subcutaneous form against a placebo, there's a chance I could be assigned to the placebo group — how would that affect my disease during the trial period, and what treatment options would I have afterward?
4The trial is no longer enrolling new participants — does that mean results might be available soon, and should we wait to see those findings before deciding on my next treatment step?
5Are there standard treatments for moderate-to-severe active thyroid eye disease that I should consider now, and how does my doctor weigh those options against waiting for or participating in a trial like this one?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proptosis responder rate (percentage of participants with a ≥ 2-mm reduction from baseline in proptosis in the study eye without deterioration [≥ 2-mm increase] of proptosis in the fellow eye).
. Participant had onset of active TED symptoms (as determined by participant records) within 15 months prior to Baseline.
. Participants must be euthyroid with the baseline disease under control or have mild hypoor 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 trial.
. Participant does not require immediate surgical ophthalmological intervention and is not planning corrective surgery/irradiation during the trial.
Exclusion criteria
. Participant has decreased best-corrected visual acuity due to optic neuropathy, defined by a decrease in vision of 2 lines on the Snellen chart (or equivalent), 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 (IV or oral) or steroid eye drops for the treatment of TED or other conditions within 3 weeks prior to Screening. Exceptions include local administration (excluding periocular), eg, topical, intra-articular, and inhaled steroids, as well as steroids used to treat infusion reactions.