A Phase 3 interventional study of Batoclimab and Placebo in Thyroid Eye Disease, sponsored by Immunovant Sciences GmbH. Completed at 45 sites in 11 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-01.
Sponsored by Immunovant Sciences GmbH · Phase 3, Interventional, and Treatment
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.
191 studies on the registry are indexed under Graves Ophthalmopathy; 58 are open to participants now.
This study's enrollment of 86 is above the median of 64 across 142 interventional studies indexed under Graves Ophthalmopathy.
Browse Graves Ophthalmopathy studies →Immunovant Sciences GmbH is the lead sponsor of 19 studies on the registry; 5 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 5 (45%) have results posted.
Counted across the registry records on this site, refreshed daily.
Have a clinical diagnosis of TED associated with active, moderate to severe TED with the following at screening and Visit 0:
Clinical evidence of worsened proptosis with:
Additional inclusion criteria are defined in the protocol.
Exclusion criteria:
Additional exclusion criteria are defined in the protocol.
Participants will be administered batoclimab 680 mg SC weekly for 12 weeks followed by 340 mg SC weekly for 12 weeks.
Drug: Batoclimab
Participants will be administered matching placebo SC weekly for 24 weeks.
Drug: Placebo
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Also known as: IMVT-1401
Matching Placebo
Percentage of proptosis responders
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.
Time frame: At Week 24
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
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.
Time frame: Baseline and Week 24
Percentage of participants with CAS of 0 or 1 in the study eye
Time frame: At Week 24
Mean change from Baseline in CAS in the study eye
Time frame: Baseline and Week 24
Percentage of participants with positive binding anti-thyroid stimulating hormone receptor (TSHR) antibody (Ab) at Baseline who achieve seroconversion
Time frame: Baseline and Week 24
Percentage of participants with decrease of at least 1 grade from Baseline in Gorman score for diplopia
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.
Time frame: Baseline and Week 24
Mean change from Baseline in proptosis in the study eye
Time frame: Baseline and Week 24
Percentage of participants with ≥6-point increase from Baseline in total Graves' ophthalmopathy - Quality of life (GO-QOL) score
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.
Time frame: 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
Time frame: Baseline and Week 24
Plan to share: No
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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Immunovant Sciences GmbH