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A Trial to Investigate Teprotumumab Subcutaneous Administration Compared With Placebo in Male and Female Adult Participants With Moderate-to-severe Active Thyroid Eye Disease

Phase 3
Recruiting
Conditions
Thyroid Eye Disease
Interventions
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
Inclusion Criteria
  1. Participant must provide written informed consent.
  2. Participant can be male or female and must be between the ages of 18 and 80 years, inclusive, at Screening.
  3. 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.
  4. 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.)
  5. 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.
  6. Participant had onset of active TED symptoms (as determined by participan
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Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PlaceboPlaceboPlacebo for teprotumumab administered SC
TeprotumumabTeprotumumabTeprotumumab administered SC
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
Mean change from Baseline in proptosis measurement in the study eyeWeek 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 1Week 24
Change from Baseline in diplopia as ordinal response categoriesWeek 24
Diplopia responder rate, defined as the percentage of participants with Baseline binocular diplopia > 0 who have a reduction of ≥ 1 gradeWeek 24
Complete diplopia responder rate, defined as the percentage of participants with a Baseline binocular diplopia score > 0 and a score of 0Week 24
Mean change from Baseline in the GO-QoL questionnaire overall scoreWeek 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

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