Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease
- Registration Number
- NCT05524571
- Lead Sponsor
- Immunovant Sciences GmbH
- Brief Summary
To evaluate the efficacy of batoclimab 680 milligrams (mg) subcutaneous (SC) once a week (QW) for 12 weeks followed by 340 mg SC QW for 12 weeks versus placebo on proptosis responder rate at Week 24.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Batoclimab Batoclimab Participants will be administered batoclimab 680 mg SC weekly for 12 weeks followed by 340 mg SC weekly for 12 weeks. Placebo Placebo Participants will be administered matching placebo SC weekly for 24 weeks.
- Primary Outcome Measures
Name Time Method Percentage of proptosis responders At Week 24 Proptosis is the amount of protrusion of the eye from the orbital rim. Measurements are recorded using the Hertel exophthalmometer. The study eye is defined as the most severely affected eye at the Baseline visit. Proptosis responder is defined as the participant with a greater than or equal to (≥) 2 millimeters (mm) reduction in the study eye without deterioration (≥2 mm increase) in the fellow eye.
- Secondary Outcome Measures
Name Time Method Percentage of participants with CAS of 0 or 1 in the study eye At Week 24 Percentage of participants with ≥6-point increase from Baseline in total Graves' ophthalmopathy - Quality of life (GO-QOL) score Baseline and Week 24 The GO-QOL is a 16-item self-administered questionnaire designed to assess how GO affects different aspects related to quality of life (visual functioning and psychosocial consequences). The points given to questions 1 to 8 and 9 to 16 are added to obtain 2 raw scores ranging from 8 to 24; one for visual functioning and one for appearance. Higher scores indicate better outcome.
Percentage of participants with proptosis ≥2 mm reduction and Clinical Activity Score (CAS) of less than or equal to (≤) 3 from Baseline in the study eye Baseline and Week 24 The CAS measures the classical signs of acute inflammation (pain, redness, and swelling) in TED. The 7-item scale assigns 1 point for the presence of each of the parameters assessed: spontaneous retrobulbar pain, pain on attempted upward or downward gaze, redness of eyelids, redness of conjunctiva, swelling of caruncle or plica, swelling of eyelids, swelling of conjunctiva (chemosis). The sum of these points is the total score, with 0 indicating no clinical activity and 7 indicating the most severe clinical activity. Higher scores indicate worse symptoms.
Percentage of participants with positive binding anti-thyroid stimulating hormone receptor (TSHR) antibody (Ab) at Baseline who achieve seroconversion Baseline and Week 24 Percentage of participants with decrease of at least 1 grade from Baseline in Gorman score for diplopia Baseline and Week 24 Diplopia will be assessed based on 3 grades: Grade I - Intermittent diplopia (diplopia in primary position of gaze, when tired or when first awakening), Grade II - Inconstant diplopia (diplopia at extremes of gaze) and Grade III - Constant diplopia (continuous diplopia in primary or reading position). Higher scores indicate worse symptoms.
Mean change from Baseline in proptosis in the study eye Baseline and Week 24 Percentage of participants with ≥8-degree increase from Baseline in motility (in at least 1 of 4 directions) in the study eye Baseline and Week 24 Mean change from Baseline in CAS in the study eye Baseline and Week 24
Trial Locations
- Locations (43)
Site Number -1514
🇺🇸Torrance, California, United States
Site Number -1510
🇺🇸Sarasota, Florida, United States
Site Number - 1521
🇺🇸Seattle, Washington, United States
Site Number -1511
🇺🇸Morgantown, West Virginia, United States
Site Number -1519
🇺🇸San Antonio, Texas, United States
Site Number - 9302
🇱🇻Ventspils, Latvia
Site Number - 9200
🇸🇰Bratislava, Slovakia
Site Number -9301
🇱🇻Ogre, Latvia
Site Number - 9201
🇸🇰Bratislava, Slovakia
Site Number -1520
🇺🇸Pasadena, California, United States
Site Number -3606
🇪🇸Sevilla, Spain
Site Number -1517
🇺🇸San Francisco, California, United States
Site Number -3601
🇪🇸Madrid, Spain
Site Number - 9202
🇸🇰Trenčín, Slovakia
Site Number - 7570
🇳🇿Christchurch, New Zealand
Site Number -3600
🇪🇸Santiago De Compostela, Spain
Site Number -3603
🇪🇸Valencia, Spain
Site Number - 3605
🇪🇸Barcelona, Spain
Site Number -3604
🇪🇸Madrid, Spain
Site Number - 4952
🇹🇷Adana, Turkey
Site Number - 4950
🇹🇷Ankara, Turkey
Site Number - 1513
🇺🇸Rochester, Minnesota, United States
Site Number - 1525
🇺🇸Portland, Oregon, United States
Site Number - 1518
🇺🇸Milwaukee, Wisconsin, United States
Site Number - 7551
🇭🇺Pécs, Hungary
Site Number - 1526
🇺🇸Livonia, Michigan, United States
Site Number -1515
🇺🇸Bellaire, Texas, United States
Site Number - 1524
🇺🇸McAllen, Texas, United States
Site Number -4671
🇧🇪Brugge, Belgium
Site Number - 7565
🇦🇺Sydney, Australia
Site Number - 4672
🇧🇪Bruxelles, Belgium
Site Number - 4673
🇧🇪Bruxelles, Belgium
Site Number -4670
🇧🇪Ghent, Belgium
Site Number - 4674
🇧🇪Liège, Belgium
Site Number - 7550
🇭🇺Budapest, Hungary
Site Number - 7552
🇭🇺Pecs, Hungary
Site Number -9300
🇱🇻Riga, Latvia
Site Number - 7572
🇳🇿Hamilton, New Zealand
Site Number -1990
🇵🇷San Juan, Puerto Rico
Site Number - 9203
🇸🇰Bratislava, Slovakia
Site Number -3602
🇪🇸Barcelona, Spain
Site Number -1516
🇺🇸Louisville, Kentucky, United States
Site Number - 1512
🇺🇸Winston-Salem, North Carolina, United States