A Trial to Investigate Teprotumumab Subcutaneous Administration Compared With Placebo in Male and Female Adult Participants With Moderate-to-severe Active Thyroid Eye Disease
- Registration Number
- NCT06248619
- Lead Sponsor
- Amgen
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
- 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.
- 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.
- Women of childbearing potential must have a negative serum pregnancy test at Screening and negative urine pregnancy tests at all protocol-specified time points (ie, prior to each dose and throughout participation in the trial).
- 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 (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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo for teprotumumab administered SC Teprotumumab Teprotumumab Teprotumumab administered SC
- Primary Outcome Measures
Name Time Method 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). Week 24
- Secondary Outcome Measures
Name Time Method Change from Baseline in diplopia as ordinal response categories Week 24 Diplopia responder rate, defined as the percentage of participants with Baseline binocular diplopia > 0 who have a reduction of ≥ 1 grade Week 24 Mean change from Baseline in proptosis measurement in the study eye Week 24 Overall responder rate (percentage of participants with ≥ 2-point reduction in CAS AND ≥ 2-mm reduction in proptosis from Baseline, provided there is no corresponding deterioration [≥ 2-point/mm increase] in CAS or proptosis in the fellow eye) Week 24 Percentage of participants with a CAS value of 0 or 1 Week 24 Complete diplopia responder rate, defined as the percentage of participants with a Baseline binocular diplopia score > 0 and a score of 0 Week 24 Mean change from Baseline in the GO-QoL questionnaire overall score Week 24
Trial Locations
- Locations (43)
Catalina Eye Care - NVISION - PPDS
🇺🇸Tucson, Arizona, United States
Shiley Eye Center University of California at San Diego
🇺🇸La Jolla, California, United States
Amy Patel Jain MD Inc.
🇺🇸Newport Beach, California, United States
Advanced Quality Medical Research
🇺🇸Orland Park, Illinois, United States
W Kellogg Eye Center
🇺🇸Ann Arbor, Michigan, United States
Las Vegas Endocrinology
🇺🇸Henderson, Nevada, United States
The Center for Eye and Facial Plastic Surgery
🇺🇸Somerset, New Jersey, United States
Casey Eye Institute -515 SW Campus Dr
🇺🇸Portland, Oregon, United States
Scheie Eye Institute
🇺🇸Philadelphia, Pennsylvania, United States
University of Tennessee Health Science Center - 848 Adams Ave
🇺🇸Memphis, Tennessee, United States
Scroll for more (33 remaining)Catalina Eye Care - NVISION - PPDS🇺🇸Tucson, Arizona, United States