Tildrakizumab for Lyell syndrome (toxic epidermal necrolysis) - ocular sequelae

Inclusion criteria

• {"criterion_text":"- Adults (≥18 years old)\n- Non-pregnant and not breastfeeding (if female)\n- Presenting with ocular sequelae of Lyell Syndrome\n- Able to provide informed consent\n- Covered by a social security scheme.\n- Patients with a history of SJS/TEN with persistent ocular symptoms or signs compatible with chronic ocular surface inflammation.\n- Visual acuity allowing assessment procedures.\n- Clinical stability allowing safe ocular examination"}

Exclusion criteria

• {"criterion_text":"- Pregnant or breastfeeding woman\n- <18 years old\n- Receipt of a live attenuated vaccine within 4 weeks prior to inclusion and/or need for a live attenuated vaccine during the study or within 17 weeks after the last dose of Tildrakizumab\n- Known hypersensitivity to tildrakizumab\n- Patients with a chronic, recurrent, or recent serious infection, or with any suspected clinically relevant active infection\n- Active infectious keratitis (bacterial, viral, fungal)\n- Corneal ulcer threatening perforation\n- Severe non-SJS/TEN–related ocular diseases (e.g., advanced glaucoma, retinal disease)."}

Primary endpoints

• {"endpoint_text":"- The primary efficacy endpoint of this study is the change in tear film break-up time (TBUT), measured in seconds, between baseline (Day 0) and post-treatment follow-up visits","definition_or_measurement_approach":"Change in TBUT measured in seconds between baseline (Day 0) and post-treatment follow-up visits."}
• {"endpoint_text":"- Secondary efficacy endpoints will consist of patient-reported outcome measures designed to capture the subjective impact of treatment on ocular symptoms and vision-related quality of life.","definition_or_measurement_approach":"Patient-reported outcome measures capturing subjective impact on ocular symptoms and vision-related quality of life (e.g., DLQI as referenced in objectives)."}

Secondary endpoints

• {"endpoint_text":"- Clinical Safety Monitoring","definition_or_measurement_approach":"General clinical safety monitoring as per protocol (no further detail provided in the record)."}
• {"endpoint_text":"- Patient-Reported Tolerability via DL-QI","definition_or_measurement_approach":"Patient-reported tolerability measured via Dermatology Life Quality Index (DLQI) or equivalent patient-reported instrument as referenced."}

France

Earliest CTIS Part Ii Submission Date

16-01-2026

Latest Decision Or Authorization Date

23-01-2026

Processing Time Days

7

Number Of Sites

1

Number Of Participants

10

Primary sponsor

Full Name

TOXILYON

Organisation Type

Health care

Country Of Registered Address

France