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
127
Satralizumab will be administered by SC injection.
Placebo will be administered by SC injection
Percentage of Participants Achieving ≥ 2 millimetres (mm) Reduction in Proptosis From Baseline (Day 1) at Week 24 in the Study Eye
Provided there is no deterioration of proptosis (≥ 2mm 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, and 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 Achieving a ≥ 2 Point Reduction in Clinical Activity Score (CAS) in the Study Eye
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Plastics-Orbit-Neuro
San Diego, California, United States
Connecticut Eye Consultants, P.C.
Danbury, Connecticut, United States
University of Illinois Eye and Ear Infirmary
Chicago, Illinois, United States
Scheie Eye Institute
Philadelphia, Pennsylvania, United States
Vanderbilt Eye Institute
Nashville, Tennessee, United States
Retina Consultants of Texas
San Antonio, Texas, United States
University of Alberta
Edmonton, Alberta, Canada
Toronto Retina Institute
Toronto, Ontario, Canada
Universite de Montreal - Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada
Peking Union Medical College Hospital
Beijing, China
...and 31 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, and Week 48
Percentage of Participants Achieving 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, designed to assess cornea and ocular surface symptoms. It comprises of 12 questions with three main sections concerning ocular symptoms, visual function, and environmental factors. For each 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 ranging from 0 to 100. Higher score indicates 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, designed to assess cornea and ocular surface symptoms. It comprises of 12 questions with three main sections concerning ocular symptoms, visual function, and environmental factors. For each 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 ranging from 0 to 100. Higher score indicates 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 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
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 up to Week 72
Serum Concentration of Satralizumab
Time frame: Up to Week 24