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Phase 3 Study to Assess Batoclimab in Participants with Active Thyroid Eye Disease
EU CTIS ID: 2024-512649-18-00
What this study is testing
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.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Are ≥18 years of age at screening.
- 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 ≥ 3mm 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.
You likely can't join if
- 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.
See the full eligibility criteria
- Are ≥18 years of age at screening.
- 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 ≥ 3mm 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- Canada
- United States
- New Zealand
- Turkey
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; Canada; United States; New Zealand; Turkey. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.