Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease

Launched by IMMUNOVANT SCIENCES GMBH · Aug 29, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a medication called batoclimab to see how well it works for people with active Thyroid Eye Disease (TED), which can cause symptoms like bulging eyes. The trial will compare batoclimab given as an injection once a week for 24 weeks to a placebo (a treatment that looks like the real medication but has no active ingredients) to see if it helps reduce the bulging of the eyes.

To be eligible for this study, participants must be at least 18 years old, have a diagnosis of moderate to severe TED with specific symptoms, and have started experiencing these symptoms within the last year. They should not need immediate surgery for TED during the study and should have stable thyroid function. Those who join the trial will receive either the medication or the placebo and will be closely monitored over the 24-week period. It's important to note that certain health conditions and recent treatments may prevent someone from participating. This study is currently recruiting participants, and it aims to find better treatments for those suffering from this condition.

Gender

ALL

Eligibility 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 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
• • 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.
• 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.