BridgeMD
A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants with Moderate-to-Severe Thyroid Eye Disease
EU CTIS ID: 2023-503309-13-00
What this study is testing
To evaluate the efficacy of subcutaneous satralizumab compared with placebo at Week 24 based on proptosis response
- 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
- Age >=18 years at the time of signing Informed Consent Form
- FOR ACTIVE TED PATIENTS: Clinical diagnosis of active thyroid eye disease (TED) with clinical activity score (CAS) >= 3 (on the 7 item scale) at screening and baseline (Day 1) in the study eye FOR CHRONIC INACTIVE TED PATIENTS: Clinical diagnosis of stable, chronic (inactive) TED, as determined by participant medical records indicating CAS < 3 (on a 7-item scale) in both eyes for at least 6 months prior to screening, or all of the following: No progression in proptosis for at least 6 months prior to screening If participant has a history of diplopia due to TED, no progression in diplopia for at least 6 months prior to screening No new inflammatory TED symptoms for at least 6 months prior to screening.
- FOR CHRONIC INACTIVE TED PATIENTS: CAS <3 (on a 7-item scale) in both eyes at screening and baseline (Day 1) visits
- FOR ACTIVE TED PATIENTS: Diagnosis of active moderate-to-severe TED; usually associated with proptosis (exophthalmos) >= 3 mm above normal for race and gender in the study eye. Additionally, participants must have one or more of the following: lid retraction >=2 mm, moderate or severe soft tissue involvement, and/or inconstant or constant diplopia. FOR CHRONIC INACTIVE TED PATIENTS: History and presence at screening and baseline of chronic TED as estimated by treating physician with proptosis (exophthalmos) >= 3 mm above normal for race and gender in the study eye. Additionally, participants must have one or more of the following: lid retraction >=2 mm, moderate or severe soft tissue involvement, and/or inconstant or constant diplopia.
- FOR ACTIVE TED PATIENTS: Onset of active TED symptoms in the study eye (as determined by participant medical records) <= 12 months prior to baseline (Day 1) FOR CHRONIC INACTIVE TED PATIENTS: Initial TED diagnosis >12 months but < 10 years prior to screening
- Euthyroid with the background disease under control, or have mild hypo- or hyperthyroidism
You likely can't join if
- Decrease in CAS or proptosis of >= 2 points or >= 2 mm, respectively, in the study eye between Screening and Study Baseline (Day 1)
- Requiring immediate surgical ophthalmological intervention or planning corrective surgery or irradiation during the course of the study, in the judgment of the investigator
- Identified pre-existing ophthalmic disease that, in the judgment of the investigator, would preclude study participation or complicate interpretation of study results, including corneal decompensation unresponsive to medical management and including ophthalmic diseases that will likely require prohibited therapy during the study
- FOR ACTIVE TED: Any prior CS use (IV or oral) with a cumulative dose equivalent to >= 1 g of methylprednisolone or equivalent for the treatment of any condition within 3 months prior to screening. FOR CHRONIC INACTIVE TED: Use of any CSs (periocular, IV, oral, IVT injections or implants) for any indication within 3 weeks prior to screening.
- Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes an individual's safe participation in and completion of the study
- Pregnant or breastfeeding, or intention of becoming pregnant during the study or within 3 months after the final dose of satralizumab
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Japan
- Argentina
- Hong Kong
- Australia
- Singapore
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 United States; Japan; Argentina; Hong Kong; Australia; Singapore. 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.