Ophthalmological Adverse Events of Tralokinumab in AD

NCT05682976 | Completed

• 1 other identifier: RC22_0628
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 11

Brief Summary

Atopic dermatitis (AD) is a skin disease characterised by xerosis, pruritus and erythematous plaques. It is common in children (10 to 20%) with an increasing prevalence (multiplied by 2 in 20 years) and begins to develop at 3 months of age. Half of all atopic dermatitis cases disappear by the age of 5, but 10 to 15% of cases persist into adulthood (i.e. about 3.5% of the French adult population). Conventional treatments consist of emollient creams, topical corticosteroid, topical immunomodulators (topical calcineurin inhibitor: tacrolimus) or systemic cyclosporine. However, a proportion of patients (10%) do not respond sufficiently to this therapeutic arsenal. Recent therapies using monoclonal antibodies (biotherapies) are available (DUPILUMAB -anti Interleukin-4 (IL4) antibody and soon TRALOKINUMAB-anti Interleukin-L13 (IL13) antibody). Conjunctivitis is an adverse event reported in patients treated with dupilumab and tralokinumab in clinical trials. Given that baseline ophthalmic comorbidities affect approximately 20% of AD patients, it is crucial to include an evaluation in future prospective real-life longitudinal studies to assess the true incidence of biologic-induced ophthalmic adverse events. No such study is currently available for Tralokinumab. The French group GREAT (GROUPE DE RECHERCHE SUR L'ECZEMA ATOPIQUE) has recently conducted a study on ocular adverse events of dupilumab (DUPI-ŒIL study, I. COSTEDOAT, M. WALLAERT et al, submitted) which included 180 patients followed for at least 4 months. The results show that the majority of dupilumab-induced conjunctivitis is de novo (frequency 18%). Conjunctivitis-type adverse events were also reported at a frequency of 3.0% to 11.0% in the ECZTRA pivotal studies with Tralokinumab. However, the ophthalmological impact of IL13 inhibition remains partially unknown. Further characterisation of ophthalmological adverse events in patients treated with Tralokinumab in real life is needed to provide information for future recommendations (including prioritisation of indications for systemic therapy) and to improve compliance. The primary objective of the TRALO-OEIL study is to determine the frequency of occurrence of ophthalmologic adverse events with TRALOKINUMAB.

Conditions

Atopic Dermatitis

Keywords

Atopic dermatitis, Tralokinumab, adverse event, conjunctivitis

Outcome Measures

Primary Outcomes (1)

• occurrence of an ophthalmologic adverse event (conjunctivitis, keratoconjunctivitis, etc.)

  the occurrence of an ophthalmologic adverse event (conjunctivitis, keratoconjunctivitis, etc.) 4 months after initiation of treatment with TRALOKINUMAB or an increase in a pre-existing ophthalmologic condition on treatment

  4 months

Secondary Outcomes (3)

• Occurrence or worsening of conjunctivitis, keratoconjunctivitis, blepharitis

  4 months

• Occurrence or worsening of conjunctivitis, keratoconjunctivitis, blepharitis

  12 months

• Severity score of ophthalmological damage

  12 months

Study Arms (1)

AD patient treated by Tralokinumab

AD patient treated by Tralokinumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated for AD requiring systemic treatment with Tralokinumab. In order to keep a representative overview of all patients with atopic dermatitis, the number of patients included after Dupilumab failure will be limited to 25%. For patients previously treated with Dupilumab, a washout period of up to one month should be observed prior to inclusion to avoid the reporting of ophthalmological events at baseline still related to Dupilumab treatment.

You may qualify if:

• Adult patient (\> 18 years),
• Patients with atopic dermatitis,
• Patients indicated for treatment with Tralokinumab
• Patients able to express non opposition.

You may not qualify if:

• Patients who have stopped Dupilumab for less than one month,
• Patients under guardianship or trusteeship
• Pregnant or breastfeeding women.

Sponsors & Collaborators

• LEO Pharma: collaborator
• Nantes University Hospital: lead

Study Sites (11)

CHU de Bordeaux

Bordeaux, France

Location

CHU de Brest

Brest, France

Location

CHU de Clermont Ferrand

Clermont-Ferrand, France

Location

CHu de Dijon

Dijon, France

Location

CHRU de Lille

Lille, France

Location

Hospice Civil de Lyon

Lyon, France

Location

CHU de Nantes

Nantes, France

Location

Hôpital Saint Louis

Paris, France

Location

CHu de Poitiers

Poitiers, France

Location

CHu de Rennes

Rennes, France

Location

CHU de Rouen

Rouen, France

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Conjunctivitis

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Conjunctival Diseases; Eye Diseases

Study Officials

• Sébastien BARBAROT, PHPH

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2022
• First Posted: January 12, 2023
• Study Start: June 14, 2023
• Primary Completion: May 20, 2025
• Study Completion: February 20, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

FR (11)