Evaluation of Tildrakizumab in the Treatment of Ocular Sequelae in Lyell syndrome

2025-522556-10-01 Therapeutic exploratory (Phase II) Authorised, recruitment pending

Status Authorised, recruitment pending · 1 EU/EEA countries · 1 sites

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)
Status Authorised, recruitment pending
Participants planned 10
Countries 1
Sites 1

Ocular Sequelae in Lyell syndrome

To evaluate the efficacy of Tildrakizumab on the ophthalmological sequelae of Lyell syndrome.

Key facts

Sponsor
Toxilyon
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Eye Diseases [C11], Diseases [C] - Immune System Diseases [C20]
Decision date (initial)
2026-01-23
Transition trial
No
Low-intervention
No
Rare-disease indication
Yes
Vulnerable population
Yes
Funding sources
TOXILYON

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To evaluate the efficacy of Tildrakizumab on the ophthalmological sequelae of Lyell syndrome.

Secondary objectives 3

  1. 1. To evaluate the general safety and tolerance of Tildrakizumab in patients with ophthalmological sequelae of Lyell syndrome.
  2. 2. To assess the impact of Tildrakizumab on patients' quality of life, as measured by the Dermatology Life Quality Index (DLQI).
  3. 3. To explore the absence of ocular deterioration as an indicator of safety (e.g., stability of tear film break-up time, corneal integrity, absence of inflammatory flare-ups).

Conditions and MedDRA coding

Ocular Sequelae in Lyell syndrome

Study design 2 periods

#TitleAllocationBlindingRoles blindedArms
1 Inclusion period
Patients meeting the eligibility criteria will be enrolled in the study over a period of 6 months from the first patient’s first visit. During this period, all screening procedures and baseline assessments will be performed, and treatment with tildrakizumab will be initiated according to the study protocol.
 2 None Tildrakizumab 100 mg subcutaneous injections.: Patients will receive tildrakizumab 100 mg subcutaneous injection at Day 0, Month 1, and Month 3, with follow-up assessments until Month 3 post-treatment.
2 Post-treatment Follow-up Period
Each patient will be followed for 6 months after the inclusion and the first administration of tildrakizumab. Follow-up visits will be performed to assess safety, tolerability, and persistence of clinical effect. The total duration of the study will be 18 months, assuming the last patient is enrolled at Month 12 of the Inclusion Period.
 2 None

Regulatory references

Plan to share IPD
No
IPD plan description
We do not plan to share individual participant data (IPD) from this study, because the sample size is small (n = 10) and the nature of the collected data (including ophthalmologic assessments and patient-reported outcomes) could allow re-identification of participants, even after anonymisation. Summary-level results, including aggregated efficacy and safety data, will be made publicly available in the Clinical Trial Information System (CTIS) according to Regulation (EU) No 536/2014. Researchers with a legitimate scientific interest may request access to selected anonymised datasets. Such requests will be considered on a case-by-case basis by the sponsor (TOXILYON), subject to data protection regulations and ethics approval, and may require a data-sharing agreement.
EU CT numberTitleSponsor
2025-522556-10-00 Evaluation of Tildrakizumab in the Treatment of Ocular Sequelae in Lyell syndrome TOXILYON

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

  1. Adults (≥18 years old)
  2. Non-pregnant and not breastfeeding (if female)
  3. Presenting with ocular sequelae of Lyell Syndrome
  4. Able to provide informed consent
  5. Covered by a social security scheme.
  6. Patients with a history of SJS/TEN with persistent ocular symptoms or signs compatible with chronic ocular surface inflammation.
  7. Visual acuity allowing assessment procedures.
  8. Clinical stability allowing safe ocular examination

Exclusion criteria 8

  1. Pregnant or breastfeeding woman
  2. <18 years old
  3. 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
  4. Known hypersensitivity to tildrakizumab
  5. Patients with a chronic, recurrent, or recent serious infection, or with any suspected clinically relevant active infection
  6. Active infectious keratitis (bacterial, viral, fungal)
  7. Corneal ulcer threatening perforation
  8. Severe non-SJS/TEN–related ocular diseases (e.g., advanced glaucoma, retinal disease).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

  1. 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
  2. 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.

Secondary endpoints 2

  1. Clinical Safety Monitoring
  2. Patient-Reported Tolerability via DL-QI

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Ilumetri 200 mg solution for injection in pre-filled syringe

PRD9673692 · Product

Active substance
Tildrakizumab
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS INJECTION
Max daily dose
200 mg milligram(s)
Max total dose
600 mg milligram(s)
Max treatment duration
3 Month(s)
Authorisation status
Authorised
ATC code
L04AC17 — -
Marketing authorisation
EU/1/18/1323/003
MA holder
ALMIRALL, S.A.
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Toxilyon

Sponsor organisation
TOXILYON
Address
25 rue Bissardon
City
Caluire-et-Cuire
Postcode
69300
Country
France

Scientific contact point

Organisation
TOXILYON
Contact name
Sponsor

Public contact point

Organisation
TOXILYON
Contact name
Sponsor

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
France Authorised, recruitment pending 10 1
Rest of world — 0 —

Investigational sites

France

1 site · Authorised, recruitment pending
Docteur Benoit Ben Said SELARL
Dermatology, 3 Avenue Henri Barbusse, 69100, Villeurbanne

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 11 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) 2025-522556-10-01_Protocol_For_Publication 2
Protocol (for publication) 2025-522556-10-01_Protocol_For_Publication_TC 1
Protocol (for publication) 2025-522556-10-01_Protocol_Not_For_Publication 2
Protocol (for publication) 2025-522556-10-01_Protocol_Not-For-Publication_TC 1
Recruitment arrangements (for publication) 2025-522556-10-01_Modalites de recrutement des participants 1
Subject information and informed consent form (for publication) 2025-522556-10-01_ Notice d_information et recueil du consentement 1
Summary of Product Characteristics (SmPC) (for publication) Tildrakizumab_IIumetri_SmPC 1
Synopsis of the protocol (for publication) 2025-522556-10-01_Synopsis of the protocol_EN 2
Synopsis of the protocol (for publication) 2025-522556-10-01_Synopsis of the protocol_FR 2
Synopsis of the protocol (for publication) 2025-522556-10-01_Synopsis_EN_TC 1
Synopsis of the protocol (for publication) 2025-522556-10-01_Synopsis_FR_TC 1

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2025-09-22 France Acceptable
2026-01-22
 2026-01-23