Thyroid Eye Disease (TED) MedDRA version: 23.1 Level: LLT Classification code 10084358 Term: Thyroid eye disease System Organ Class: 10015919 - Eye disorders
Conditions
Sponsors
Immunovant Sciences, GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Are =18 years of age at screening. 2. Have a clinical diagnosis of TED associated with active, moderate to severe TED with a CAS =4 in either eye, and clinical evidence of worsened proptosis with: -proptosis = 18 mm and/or -proptosis = 3 mm increase from participant's baseline (prior to diagnosis of TED), as estimated by the Investigator/assessor 3. Have moderate to severe active TED, as defined by European Group on Graves' Orbitopathy (EUGOGO) guidelines. 4. Have onset of active TED within 12 months prior to screening. 5. Have documented evidence of detectable anti-TSHR-Ab at screening. 6. Are not expected to require immediate surgical intervention and are not planning corrective surgery/irradiation or medical therapy for TED during the course of the study. 7. Are euthyroid with the baseline disease under control or have mild hypo- or hyperthyroidism. Additional inclusion criteria are defined in the protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 90 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1. Have decreased best corrected visual acuity due to optic neuropathy. 2. Have at least a 2-point decrease in CAS or =2 mm decrease in proptosis between screening and Baseline assessments in either eye. 3. Have used any steroid (intravenous or oral) for the treatment of TED or other conditions within 4 weeks prior to screening. 4. Have used any steroid (Intravenous or oral) with a cumulative dose equivalent to = 1 g of methylprednisolone for the treatment of TED. 5. Have known autoimmune disease other than TED, that, in the opinion of the Investigator, would interfere with the course and conduct of the study. 6. Had previous orbital irradiation or surgery for TED. Additional exclusion criteria are defined in the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of batoclimab 680 mg subcutaneously (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;Secondary Objective: • To evaluate the efficacy of batoclimab compared to placebo as assessed by proptosis and Clinical Activity Score (CAS) • To evaluate the efficacy of batoclimab compared to placebo as assessed by CAS • To evaluate the efficacy of batoclimab compared to placebo assessed by change in binding anti-TSHR antibodies (Abs) • To evaluate the efficacy of batoclimab compared to placebo as assessed by Gorman score for diplopia • To evaluate the efficacy of batoclimab compared to placebo as assessed by proptosis • To evaluate the efficacy of batoclimab compared to placebo as assessed by Graves’ ophthalmology-specific quality of life (GO-QOL) • To evaluate the efficacy of batoclimab compared to placebo as assessed by motility;Primary end point(s): Proportion of proptosis responders (proptosis responder rate) at Week 24 where proptosis responder is defined as the participant with a = 2 mm reduction in the study eye without deterioration (= 2 mm increase) in the fellow eye;Timepoint(s) of evaluation of this end point: Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Proportion of participants with proptosis = 2 mm reduction and CAS of = 3 at Week 24 from baseline in the study eye • Proportion of participants with CAS of 0 or 1 at Week 24 in the study eye • Mean change from baseline to Week 24 in CAS in the study eye • Proportion of participants with positive binding anti-TSHR Ab at baseline who achieve seroconversion at Week 24 • Proportion of participants with decrease of at least 1 grade from baseline in Gorman score for diplopia at Week 24 in participants who have diplopia at baseline. • Mean change from baseline to Week 24 in proptosis (mm) in the study eye • Proportion of participants with = 6-point increase from baseline in total GO-QOL score at Week 24 in participants who have the ability to increase by = 6-points from baseline • Proportion of participants with = 8-degree increase from baseline in motility (in at least 1 of 4 directions) at Week 24 in the study eye in participants who have the ability to increase by = 8 degrees from baseline.;Timepoint(s) of evaluation of this end point: Week 24 | — |
Countries
Australia, Belgium, Canada, Germany, Hungary, Latvia, New Zealand, Slovakia, Spain, Turkey, United States
Contacts
Public ContactCentral Study Contact
Immunovant Sciences GmbH
Outcome results
None listed