Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease

Conditions de participation

• Sexe:

  ALL

• Âges admissibles:

  18 and up

Critères de participation

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:

1. Proptosis ≥ 18 mm and/or
2. 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:

* 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.