A Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Participants With Thyroid Eye Disease

JRCT ID: jRCT2011230041

Registered date:29/09/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: thyroid eye disease(TED)
• Date of first enrollment: 02/02/2024
• Target sample size: 120
• Countries of recruitment: Argentina,Japan,Hong Kong,Japan,USA,Japan,Germany,Japan,Italy,Japan,Australia,Japan,Singapore,Japan
• Study type: Interventional
• Intervention(s): Satralizumab: SC injection at protocol-specified doses every 4 weeks (Q4W)

Outcome(s)

Primary Outcome

efficacy
To evaluate the efficacy of satralizumab compared with placebo
-Percentage of participants achieving >= 2mm reduction in proptosis from baseline (Day 1) at Week 24 in the study eye
(Provided there is no deterioration of proptosis (>= 2mm increase) in the fellow eye)

Secondary Outcome

safety, efficacy, phamacokinetics, phamacodynamics, other
To evaluate the efficacy of satralizumab compared with placebo
-Change in proptosis from baseline to Week 24
-Percentage of participants achieving >= 1 grade reduction/improvement in diplopia among participants with baseline diplopia

To evaluate the safety of satralizumab compared with placebo
-Percentage of participants with adverse events (AEs), with severity determined according to National cancer institute common terminology criteria for adverse events version 5 (NCI CTCAE V5)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Clinical diagnosis of thyroid eye disease (TED) based on CAS

Exclude criteria

-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
-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 12 weeks after the final dose of satralizumab

Related Information

• Primary Sponsor: Giulio Barteselli
• Secondary ID(s): NCT05987423