Ophthalmological Adverse Events of Tralokinumab in AD

Atopic Dermatitis Clinical Trial

— TRALO-Oeil  

Official title:

Prospective Multicentre Study on Ophthalmological Adverse Events of Tralokinumab in the Treatment of Atopic Dermatitis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05682976
• Other study ID #: RC22_0628
• Status: Not yet recruiting
• Start date: March 2023
• Est. completion date: March 2026

Study information

• Verified date: November 2022
• Source: Nantes University Hospital
• Contact: Sébastien Barbarot, PUPH
• Phone: 0240084086
• Email: sebastien.barbarot[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The study consists of following over 12 months patients who have been prescribed Tralokinumab to treat their AD.

The inclusion visit takes place on the day of initiation of TRALOKINUMAB. Current ophthalmic follow-up recommendations include an initial examination before the start of treatment and then regularly during treatment and in case of ocular events. Patients are advised to consult the ophthalmology department of the university hospital where they are treated promptly in case of ophthalmological adverse events.

The investigators will collect data from the initial routine visit (M0) and from visits at 4 months (M4) and 12 months (M12).

Any other visits for ocular events during follow-up will be collected (Unscheduled visits).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: March 2026
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patient (> 18 years),

• Patients with atopic dermatitis,

• Patients indicated for treatment with Tralokinumab

• Patients able to express non opposition.

Exclusion Criteria:

• Patients who have stopped Dupilumab for less than one month,

• Patients under guardianship or trusteeship

• Pregnant or breastfeeding women.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux
France	CHU de Brest	Brest
France	CHU de Clermont Ferrand	Clermont-Ferrand
France	CHu de Dijon	Dijon
France	CHRU de Lille	Lille
France	Hospice Civil de Lyon	Lyon
France	CHU de Nantes	Nantes
France	Hôpital Saint Louis	Paris
France	CHu de Poitiers	Poitiers
France	CHu de Rennes	Rennes
France	CHU de Rouen	Rouen

Sponsors (2)

Lead Sponsor	Collaborator
Nantes University Hospital	LEO Pharma

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Occurrence or worsening of conjunctivitis, keratoconjunctivitis, blepharitis	Occurrence or worsening of conjunctivitis, keratoconjunctivitis, blepharitis,... within 4 months of initiation of TRALOKINUMAB	4 months
Secondary	Occurrence or worsening of conjunctivitis, keratoconjunctivitis, blepharitis	Occurrence or worsening of conjunctivitis, keratoconjunctivitis, blepharitis,... within 12 months of initiation of TRALOKINUMAB	12 months
Secondary	Severity score of ophthalmological damage	Severity score of ophthalmological damage used in a previous study (DUPI-ŒIL study, I. Costedoat, M. Wallaert et al, submitted). minimum value: 0, maximum value: 68. A lower score mean a better outcome.	12 months