A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Thyroid Eye Disease
- Conditions
- Thyroid Eye Disease
- Interventions
- Drug: Placebo
- Registration Number
- NCT06106828
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 127
- Clinical diagnosis of TED based on CAS
- Decrease in CAS or proptosis of >≥ 2 points or ≥ 2 mm, respectively, in the study eye between Screening and Study Baseline (Day 1)
- Requiring immediate surgical ophthalmological intervention or planning corrective surgery or irradiation during the course of the study, in the judgment of the investigator
- Identified pre-existing ophthalmic disease that, in the judgment of the investigator, would preclude study participation or complicate interpretation of study results, including corneal decompensation unresponsive to medical management and including ophthalmic diseases that will likely require prohibited therapy during the study
- Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes an individual's safe participation in and completion of the study
- Pregnant or breastfeeding, or intention of becoming pregnant during the study or within 3 months after the final dose of satralizumab
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Satralizumab Satralizumab In the Part I period, participants will receive satralizumab every 4 weeks (q4w) followed by proptosis response-based individualized treatment in Part II of the study. Placebo Placebo In the part I period, participants will receive placebo q4w followed by proptosis response-based individualized treatment in part II of the study.
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving ≥ 2 millimetres (mm) Reduction in Proptosis From Baseline (Day 1) at Week 24 in the Study Eye Baseline, Week 24 Provided there is no deterioration of proptosis (≥ 2mm increase) in the fellow eye.
- Secondary Outcome Measures
Name Time Method Change in Proptosis 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 Baseline, Week 24, and Week 48 Percentage of Participants Achieving Absence of Motility-induced Pain Week 24 Percentage of Participants Achieving Absence of Spontaneous Pain 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) Baseline, Week 24, Week 48 and from Week 24 to Week 48 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.
Percentage of Participants Achieving Overall Response Week 24, Week 48 Percentage of Participants Achieving a ≥ 2 Point Reduction in Clinical Activity Score (CAS) in the Study Eye Baseline, Week 24, and Week 48 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.
Percentage of Participants Achieving CAS Value of 0 or 1 in the Study eye Week 24 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.
Percentage of Participants Achieving ≥ 10-point Improvement in Ocular Surface Disease Index (OSDI) Overall Scores Baseline, Week 24 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.
Change in OSDI Ocular Symptoms and Vision-related Function Subscale Scores Baseline, Week 24 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.
Change in Oxford Corneal Staining Scores Baseline, Week 24 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.
Percentage of Participants Achieving ≥ 2mm Reduction in Proptosis at Week 48 in the Study eye Week 48 Percentage of Participants Requiring Surgical Intervention for TED Up to Week 48 Percentage of Participants With Worsening of Proptosis by ≥ 2 mm Baseline, Week 48 and from Week 24 to Week 48 Change in CAS 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) Baseline up to Week 72 Serum Concentration of Satralizumab Up to Week 24
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
Trial Locations
- Locations (41)
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 City, China
Scroll for more (31 remaining)Plastics-Orbit-Neuro🇺🇸San Diego, California, United States