Atopic DermatitisTRALO-OeilNCT05682976
Ophthalmological Adverse Events of Tralokinumab in AD
An observational study of Atopic Dermatitis, run by Nantes University Hospital at 11 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- How many people
- 100 participants
- Where
- 11 sitesFrance
- Study dates
- 14 Jun 2023to 20 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adult patient (> 18 years),
- Patients with atopic dermatitis,
- Patients indicated for treatment with Tralokinumab
- Patients able to express non opposition.
Who cannot join
- Patients who have stopped Dupilumab for less than one month,
- Patients under guardianship or trusteeship
- Pregnant or breastfeeding women.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
CHU de Bordeaux
Bordeaux
CHU de Brest
Brest
CHU de Clermont Ferrand
Clermont-Ferrand
CHu de Dijon
Dijon
CHRU de Lille
Lille
Hospice Civil de Lyon
Lyon
CHU de Nantes
Nantes
Hôpital Saint Louis
Paris
CHu de Poitiers
Poitiers
CHu de Rennes
Rennes
CHU de Rouen
Rouen
About this study
Official title: Prospective Multicentre Study on Ophthalmological Adverse Events of Tralokinumab in the Treatment of Atopic Dermatitis
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.
Read the 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
- Keywords
- Atopic dermatitis, Tralokinumab, adverse event, conjunctivitis
- Medical subject headings
- Dermatitis, Atopic, Conjunctivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| AD patient treated by Tralokinumab | AD patient treated by Tralokinumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 months
Secondary outcomes (3)
Occurrence or worsening of conjunctivitis, keratoconjunctivitis, blepharitis
Occurrence or worsening of conjunctivitis, keratoconjunctivitis, blepharitis,... within 4 months of initiation of TRALOKINUMAB
Measured: 4 months
Occurrence or worsening of conjunctivitis, keratoconjunctivitis, blepharitis
Occurrence or worsening of conjunctivitis, keratoconjunctivitis, blepharitis,... within 12 months of initiation of TRALOKINUMAB
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start14 Jun 2023
- Primary completion20 May 2025
- Study completion20 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- LEO Pharma
- Responsible party
- Sponsor
- Investigators
- Sébastien BARBAROT, PHPH, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05682976
- Sponsor's protocol ID
- RC22_0628
- Acronym
- TRALO-Oeil
- Status last verified
- Apr 2026
- First submitted
- 9 Dec 2022
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicentre Study on Ophthalmological Adverse Events of Tralokinumab in the Treatment of Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT05682976
- Acronym / sponsor ID
- TRALO-Oeil / RC22_0628
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic dermatitis, Tralokinumab, adverse event, conjunctivitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- LEO Pharma
- Study start
- 14 Jun 2023 (actual)
- Primary completion
- 20 May 2025 (actual)
- Study completion
- 20 Feb 2026 (actual)
- First posted
- 12 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AD patient treated by Tralokinumab | – | –AD patient treated by Tralokinumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Adult patient (> 18 years),
- Patients with atopic dermatitis,
- Patients indicated for treatment with Tralokinumab
- Patients able to express non opposition.
Key exclusion criteria (3 listed)
- Patients who have stopped Dupilumab for less than one month,
- Patients under guardianship or trusteeship
- Pregnant or breastfeeding women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
occurrence of an ophthalmologic adverse event (conjunctivitis, keratoconjunctivitis, etc.)
Time frame: 4 months
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
3 secondary outcomes
Occurrence or worsening of conjunctivitis, keratoconjunctivitis, blepharitis
Time frame: 4 months
Occurrence or worsening of conjunctivitis, keratoconjunctivitis, blepharitis
Time frame: 12 months
Severity score of ophthalmological damage
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sébastien BARBAROT, PHPH principal investigator
Nantes University Hospital
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis, run by Nantes University Hospital at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
occurrence of an ophthalmologic adverse event (conjunctivitis, keratoconjunctivitis, etc.) (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.