The purpose of this study is to assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of subcutaneous (SC) satralizumab, a recombinant, humanized anti-interleukin-6 (IL-6) receptor monoclonal antibody, in participants with thyroid eye disease (TED).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
131
Satralizumab will be administered by SC injection.
Placebo will be administered by SC injection
Percentage of Participants Achieving ≥ 2mm Reduction in Proptosis from Baseline (Day 1) at Week 24 in the Study eye
Provided there is no deterioration of proptosis \[≥ 2 millimeters (mm) increase\] in the fellow eye
Time frame: Baseline, Week 24
Change in Proptosis
Time frame: Baseline, Week 24, Week 48 and from Week 24 to Week 48
Percentage of Participants Achieving ≥ 1 Grade Reduction/Improvement in Diplopia Among Participants with Baseline Diplopia
Time frame: Baseline, Week 24, Week 48
Percentage of Participants Achieving Absence of Motility-induced Pain
Time frame: Week 24
Percentage of Participants Achieving Absence of Spontaneous Pain
Time frame: Week 24
Percentage of Participants with a ≥ 6 Point Improvement in the Visual Functioning and Appearance Sub-Scale Scores of the Graves Ophthalmopathy Quality of Life (GO-QoL)
The GO-QoL is a 16-item self-administered questionnaire divided into two sub-scales and used to assess the perceived effects of TED by the participants on their: 1) Visual Functioning (questions 1-8); and 2) Appearance (questions 9-16). Both the subscales and overall score are transformed to a scale of 0 to 100. Higher total scores indicate better QoL.
Time frame: Baseline, Week 24, Week 48 and from Week 24 to Week 48
Percentage of Participants Achieving Overall Response
Time frame: Week 24. Week 48
Percentage of Participants Achieiving ≥2 Point Reduction in Clinical Activity Score (CAS) in the Study eye
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Thrive Health Research LLC
Beverly Hills, California, United States
UCSD Shiley Eye Center
La Jolla, California, United States
Grene Vision Group, LLC
Wichita, Kansas, United States
Johns Hopkins University
Baltimore, Maryland, United States
University of Michigan, Kellogg Eye Center
Ann Arbor, Michigan, United States
Great Lakes Eye Care
Saint Joseph, Michigan, United States
'Northwell Health Physician Partners Ophthalmology
Great Neck, New York, United States
EyeHealth Northwest
Portland, Oregon, United States
Austin Retina Associates
Austin, Texas, United States
Eyelid Center of Utah
Salt Lake City, Utah, United States
...and 36 more locations
The CAS is a 7-item description of clinical activity, including: 1. Spontaneous orbital pain; 2. Gaze evoked orbital pain; 3. Eyelid swelling that is considered to be due to TED; 4. Eyelid erythema; 5. Conjunctival redness that is considered to be due to active TED (ignore "equivocal" redness); 6. Chemosis; 7. Swelling of caruncle or plica. Each item is scored as 1 (present) or 0 (absent) and scores for each item are summed for total score of 0 (no inflammatory symptoms) to 7 (most inflammatory symptoms). Higher scores indicate worse symptoms.
Time frame: Baseline, Week 24, Week 48
Percentage of Participants Acheiving CAS Value of 0 or 1 in the Study eye
The CAS is a 7-item description of clinical activity, including: 1. Spontaneous orbital pain; 2. Gaze evoked orbital pain; 3. Eyelid swelling that is considered to be due to TED; 4. Eyelid erythema; 5. Conjunctival redness that is considered to be due to active TED (ignore "equivocal" redness); 6. Chemosis; 7. Swelling of caruncle or plica. Each item is scored as 1 (present) or 0 (absent) and scores for each item are summed for total score of 0 (no inflammatory symptoms) to 7 (most inflammatory symptoms). Higher scores indicate worse symptoms.
Time frame: Week 24
Percentage of Participants Achieving ≥ 10 point Improvement in Ocular Surface Disease Index (OSDI) Overall Scores
The OSDI instrument is a validated dry eye questionnaire and consists of three main sections concerning ocular symptoms, visual function, and environmental factors. It comprises of 12 questions and for every question, participants selects a number between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time" with totals of score ranging from 0 to 100. Higher scores represents a worse disease index.
Time frame: Baseline, Week 24
Change in OSDI Ocular Symptoms and Vision-related Function Subscale Scores
The OSDI instrument is a validated dry eye questionnaire and consists of three main sections concerning ocular symptoms, visual function, and environmental factors. It comprises of 12 questions and for every question, participants selects a number between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time" with totals of score ranging from 0 to 100. Higher scores represents a worse disease index.
Time frame: Baseline, Week 24
Change in Oxford Corneal Staining Scores
Oxford corneal staining chart consists of a 6 point scale. Staining assessment will be based on the intensity of fluorescein staining, ranging from Grade 0 to V for each panel (Grade 0-I: normal; Grade II-III: mild to moderate; Grade IV-V: severe). Higher grade indicates worse worse disease index.
Time frame: Baseline, Week 24
Percentage of Participants Achieving ≥ 2mm Reduction in Proptosis at Week 48 in the Study eye
Time frame: Week 48
Percentage of Participants Requiring Surgical Intervention for TED
Time frame: Up to Week 48
Percentage of Participants With Worsening of Proptosis by ≥ 2 mm
Time frame: Baseline, Week 48 and from Week 24 to Week 48
Change in CAS
The CAS is a 7-item description of clinical activity, including: 1. Spontaneous orbital pain; 2. Gaze evoked orbital pain; 3. Eyelid swelling that is considered to be due to TED; 4. Eyelid erythema; 5. Conjunctival redness that is considered to be due to active TED (ignore "equivocal" redness); 6. Chemosis; 7. Swelling of caruncle or plica. Each item is scored as 1 (present) or 0 (absent) and scores for each item are summed for total score of 0 (no inflammatory symptoms) to 7 (most inflammatory symptoms). Higher scores indicate worse symptoms.
Time frame: Baseline, Week 48 and from Week 24 to Week 48
Percentage of Participants with Adverse Events (AEs), with Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5 (NCI CTCAE V5)
Time frame: Baseline, Week 72
Serum Concentration of Satralizumab
Time frame: Up to Week 24