The primary objective of this study is to investigate the efficacy, safety, and tolerability of RV 001 (teprotumumab), a fully human anti-IGF1R antibody, administered q3W for 6 months, in comparison to placebo, in the treatment of participants suffering from active TED. "Funding Source - FDA OOPD"
Study with completed results acquired from Horizon in 2024.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
88
Jules Stein Eye Institute at UCLA
Los Angeles, California, United States
University of Denver
Aurora, Colorado, United States
Responder Status at Week 24
Number of participants classified as responders and non-responders at Week 24. Responders were defined as participants with a reduction in clinical activity score (CAS, see Outcome Measure 4 description for details) of ≥ 2 points, and a reduction in proptosis (amount of protrusion of the eye from the orbital rim) of ≥ 2 mm in the study eye, and no deterioration (increase in CAS of ≥ 2 points or increase in proptosis of ≥ 2 mm) in the non-study eye. Participants who had no assessment at 24 weeks were considered non-responders.
Time frame: Week 24
Overall Average Change From Baseline in Graves' Ophthalmopathy Quality of Life (GO-QOL) Scale - Overall to Week 24 (Mixed-Model Repeated Measures [MMRM])
The GO-QOL is a 16-item self-administered questionnaire used to assess the perceived effects of thyroid eye disorder (TED) by the participants on their daily physical and psychosocial functioning. Two subscales of the 16-question GO-QOL have been defined: Visual Functioning and Appearance, with 8 questions comprising each subscale. The transformed overall score is the sum of scores from all 16 questions to a scale of 0 (worst health) to 100 (best health).
Time frame: Baseline to Week 24
Overall Average Change From Baseline in Proptosis of the Study Eye to Week 24 (MMRM)
Proptosis is the amount of protrusion of the eye from the orbital rim. Measurements were recorded using the Hertel exophthalmometer. Participants with a decrease ≥ 2 mm were considered improving, those with an increase or decrease \< 2 mm were considered remaining stable, and those with an increase ≥ 2 mm were considered worsening.
Time frame: Baseline to Week 24
Overall Average Change From Baseline in CAS to Week 24 (MMRM)
The 7-item European Group on Graves' Ophthalmopathy (EUGOGO) amended CAS was used to evaluate clinical activity. For each of the following items, one point is given: spontaneous orbital pain, gaze evoked orbital pain, eyelid swelling that is considered to be due to active (inflammatory phase) Graves' ophthalmopathy (GO), eyelid erythema, conjunctival redness that is considered to be due to active (inflammatory phase) GO, chemosis, and inflammation of caruncle or plica. The sum of these points is the total score, with 0 indicating no clinical activity and 7 indicating the most severe clinical activity.
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Emory University Department of Ophthalmology
Atlanta, Georgia, United States
University of Iowa Hospitals and Clinics, Department of Ophthalmology
Iowa City, Iowa, United States
Kellogg Eye Center at University of Michigan
Ann Arbor, Michigan, United States
Washington University Department of Ophthalmology
St Louis, Missouri, United States
University of Nebraska Medical Center Department of Ophthalmology
Omaha, Nebraska, United States
Casey Eye Institute at Oregon Health and Science University
Portland, Oregon, United States
Hamilton Eye Institute at University of Tennessee
Memphis, Tennessee, United States
Eye Wellness Center
Houston, Texas, United States
...and 5 more locations
Time frame: Baseline to Week 24
Overall Average Change From Baseline in GO-QOL Scale - Visual Functioning to Week 24 (MMRM)
The GO-QOL is a 16-item self-administered questionnaire used to assess the perceived effects of TED by the participants on their daily physical and psychosocial functioning. Two subscales of the 16-question GO-QOL have been defined: Visual Functioning and Appearance, with 8 questions comprising each subscale. Transformed Visual Functioning score is the sum of scores from following 8 questions to a scale of 0 (worst health) to 100 (best health): bicycling, driving, moving around the house, walking outdoors, reading, watching television (TV), hobby or pastime, feel hindered.
Time frame: Baseline to Week 24
Overall Average Change From Baseline in GO-QOL Scale - Appearance to Week 24 (MMRM)
The GO-QOL is a 16-item self-administered questionnaire used to assess the perceived effects of TED by the participants on their daily physical and psychosocial functioning. Two subscales of the 16-question GO-QOL have been defined: Visual Functioning and Appearance, with 8 questions comprising each subscale. Transformed Appearance score is the sum of scores from the following 8 questions to a scale of 0 (worst health) to 100 (best health): feel appearance has changed, feel being stared at, feel people react unpleasantly, influence on self-confidence, feel socially isolated, influence on making friends, appear less often on photos, try to mask changes in appearance.
Time frame: Baseline to Week 24