Active Thyroid Eye Disease
Conditions
Interventions
- Batoclimab group: Participants will be administered batoclimab 680 mg SC weekly for 12 weeks followed by 340 mg SC weekly for 12 weeks.
- Placebo group: Participants will be administered matching pl
Sponsors
Yamazaki Kenji
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Are >=18 years of age at screening. - Have a clinical diagnosis of TED associated with active, moderate to severe TED with the following at screening and Visit 0: -- 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 - Have moderate to severe active TED, as defined by European Group on Graves' Orbitopathy (EUGOGO) guidelines. - Have onset of active TED within 12 months prior to screening. - Have documented evidence of detectable anti-TSHR-Ab at screening. - 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. - Are euthyroid with the baseline disease under control or have mild hypo- or hyperthyroidism. Additional inclusion criteria are defined in the protocol.
Exclusion criteria
Exclusion criteria: - Have decreased best corrected visual acuity due to optic neuropathy. - Have at least a 2-point decrease in CAS or >=2 mm decrease in proptosis between screening and baseline assessments in either eye. - Have used any steroid (intravenous or oral) for the treatment of TED or other conditions within 4 weeks prior to screening. - Have used any steroid (Intravenous or oral) with a cumulative dose equivalent to >= 1 g of methylprednisolone for the treatment of TED. - Have known autoimmune disease other than TED, that, in the opinion of the Investigator, would interfere with the course and conduct of the study. - Had previous orbital irradiation or surgery for TED. Additional exclusion criteria are defined in the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Canada, Georgia, Germany, Israel, Italy, Japan, Poland, UK, US
Contacts
Public ContactKenji Yamazaki
Syneos Health Japan K.K.
Outcome results
None listed