ClinicalTrials.gg
RecruitingNCT04276623Updated Nov 29, 2023

Identifying Atopic Dermatitis Patients at Risk for Developing Conjunctivitis During Dupilumab Treatment

An observational study in Atopic Dermatitis, sponsored by UMC Utrecht. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-29.

Sponsored by UMC Utrecht · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 10 months ago, but the record still lists the study as recruiting.
  • Started Feb 2020; still recruiting 6 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
18 Years and older
Sex
All
01

Study summary

Study on ophthalmological comorbidities and the underlying pathomechanisms of conjunctivitis during dupilumab treatment in atopic dermatitis (AD) patients. Patients participate in the Bioday Registry.

02

Conditions studied

  • Atopic Dermatitis

Keywords

  • Dupilumab
  • Dupixent
  • Conjunctivitis
  • Bioday
03

In context

Dermatitis, Atopic

1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.

This study's planned enrollment of 150 is close to the median of 150 across 282 observational studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

UMC Utrecht is the lead sponsor of 364 studies on the registry; 82 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Adult patients with atopic dermatitis indicated for dupilumab, without current use of oral immunosuppressive treatment .

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult patients with atopic dermatitis indicated for dupilumab, without current use of oral treatment .

Exclusion criteria

Exclusion Criteria:

  • Treatment with oral or ocular drugs 2 weeks prior to start of dupilumab treatment
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

This study also gives Dupilumab. No intervention listed here names it: that was found by reading the record.

06

What researchers measure

Primary outcomes

  1. Relationship between goblet cell density and the incidence of conjunctivitis over time

    Establish the relationship between goblet cell densitiy and the incidence of conjunctivitis during dupilumab treatment in AD patients. Goblet cell density will determined by counting the goblet cells. The amount of goblet cells will be compared at different time points. Goblet cells will be collected using Impression Cytology of the conjunctiva and will be stained directly.

    Time frame: change of goblet cell density between baseline, 4 weeks and 28 weeks after start dupilumab, at the moment of the development of eye symptoms, 4 weeks after ocular treatment

  2. Relationship between goblet cell density and the risk of conjunctivitis

    Establish the relationship between goblet cell densitiy and the risk of conjunctivitis during dupilumab treatment in AD patients. Goblet cell density will determined by counting the goblet cells. The amount of goblet cells will be compared at different time points. Goblet cells will be collected using Impression Cytology of the conjunctiva and will be stained directly.

    Time frame: change of goblet cell density between baseline, 4 weeks and 28 weeks after start dupilumab, at the moment of the development of eye symptoms, 4 weeks after ocular treatment

Secondary outcomes

  1. Conjunctival changes during dupilumab treatment using Impression Cytology

    Better understanding of conjunctival changes using Impression Cytology of the conjunctiva, collected at different time points during treatment with dupilumab in AD patients

    Time frame: baseline, 4 weeks and 28 weeks after start dupilumab, at the moment of the development of eye symptoms, 4 weeks after ocular treatment

  2. Optimal treatment of conjunctivitis

    Establish the most optimal treatment of conjunctivitis during dupilumab treatment. Ophthalmological examination will be compared at all time points to determine if the prescribed therapy is effective and optimal.

    Time frame: at the moment of the development of eye symptoms, 4 weeks after ocular treatment

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2020 (actual). Primary completion is estimated for Dec 2023, 46 months after the start.

Of 96 non-industry observational studies under Dermatitis, Atopic, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 19. This study's planned 46 months is below that.

Counting every sponsor, half of 170 studies reached it within 35 months; a quarter within 17.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 10, 2020
First posted
Feb 19, 2020
StartActual
Feb 25, 2020
Primary completionEst.
Dec 31, 2023
CompletionEst.
Dec 31, 2023
Last update
Nov 29, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04276623
Lead sponsor
UMC Utrecht
Collaborators
Sanofi
Responsible party
Dr M.S. de Bruin-Weller (Principle Investigator, UMC Utrecht) — Principal investigator
First posted
Feb 19, 2020
Start date
Feb 25, 2020
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Nov 29, 2023

Study contacts

Roselie Achten, MD
Contact
r.e.achten@umcutrecht.nl
0031 88 75 57439
Marjolein de Bruin-Weller, MD, PhD
Contact
m.s.debruin-weller@umcutrecht.nl

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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