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 participan
Not provided
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 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 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 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 (22)
Advanced Quality Medical Research
🇺🇸Orland Park, Illinois, United States
The Center for Eye and Facial Plastic Surgery
🇺🇸Somerset, New Jersey, United States
Catalina Eye Care
🇺🇸Tucson, Arizona, United States
Shiley Eye Center University of California at San Diego
🇺🇸La Jolla, California, United States
Cockerham Eye Consultants PC
🇺🇸San Diego, California, United States
KU Medical Center, University of Kansas
🇺🇸Kansas City, Kansas, United States
W Kellogg Eye Center
🇺🇸Ann Arbor, Michigan, United States
Scheie Eye Institute
🇺🇸Philadelphia, Pennsylvania, United States
Baylor College of Medicine-1977 Butler Blvd
🇺🇸Houston, Texas, United States
Aesthetic Facial and Oculoplastic Surgeons
🇺🇸San Antonio, Texas, United States
University of Washington Eye Institute
🇺🇸Seattle, Washington, United States
West Virginia University Eye Institute
🇺🇸Morgantown, West Virginia, United States
Organización Médica de Investigación
🇦🇷Ciudad Autónoma de Buenos Aires, Ciudad Autónoma De BuenosAires, Argentina
Sydney Eye Hospital
🇦🇺Sydney, New South Wales, Australia
Queensland Eye Institute
🇦🇺Wooloongabba, Queensland, Australia
Centre For Eye Research Australia Ltd
🇦🇺East Melbourne, Victoria, Australia
Hayashi Eye Hospital
🇯🇵Fukuoka-Shi, Hukuoka, Japan
Kozawa Eye hospital and Diabetes Center
🇯🇵Mito-Shi, Ibaraki, Japan
Ishikawa Prefectural Central Hospital
🇯🇵Kanazawa-shi, Isikawa, Japan
University of Miyazaki Hospital
🇯🇵Miyazaki-Shi, Miyazaki, Japan
Niigata University Medical and Dental Hospital
🇯🇵Niigata-Shi, Niigata, Japan
Gokeikai Osaka Kaisei Hospital
🇯🇵Osaka-Shi Yodogawa-Ku, Ôsaka, Japan