Study to Assess Batoclimab in Participants with Active Thyroid Eye Disease

JRCT ID: jRCT2071240006

Registered date:16/04/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Active Thyroid Eye Disease
• Date of first enrollment: 30/04/2024
• Target sample size: 15
• Countries of recruitment: Canada,Japan,US,Japan,Georgia,Japan,Germany,Japan,Israel,Japan,Italy,Japan,Poland,Japan,UK,Japan
• Study type: Interventional

Intervention(s)

- 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 placebo SC weekly for 24 weeks.

Outcome(s)

• Primary Outcome: 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.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Yamazaki Kenji
• Secondary ID(s): 2022-002787-68,NCT05517421