Ophthalmological Adverse Events of Tralokinumab in AD

NCT ID: NCT05682976

Last Updated: 2023-01-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-03-31
• Study Completion Date: 2026-03-31

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.

Detailed 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).

Conditions

Atopic Dermatitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

AD patient treated by Tralokinumab

AD patient treated by Tralokinumab

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LEO Pharma

INDUSTRY

Sponsor Role: collaborator

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sébastien BARBAROT, PHPH

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

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, , France

Countries

France

Central Contacts

Sébastien Barbarot, PUPH

Role: CONTACT

sebastien.barbarot@chu-nantes.fr

0240084086

Aurore FOUREAU

Role: CONTACT

aurore.foureau@chu-nantes.fr

+33(0)240083722

Facility Contacts

Julien SENESCHAL

Role: primary

Laurent MISERY

Role: primary

Justine PASTEUR

Role: primary

Camille LELEU

Role: primary

Delphine STAUMONT-SALLE

Role: primary

Audrey NOSBAUM

Role: primary

Sébastien BARBAROT

Role: primary

Marie JACHIET

Role: primary

Marie MASSON-REGNAULT

Role: primary

Catherine DROITCOURT

Role: primary

Florence TETART

Role: primary

Other Identifiers

RC22_0628

Identifier Type: -

Identifier Source: org_study_id