NCT04276623

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 19, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

February 25, 2020

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

3.8 years

First QC Date

February 10, 2020

Last Update Submit

November 28, 2023

Conditions

Atopic Dermatitis

Keywords

DupilumabDupixentConjunctivitisBioday

Outcome Measures

Primary Outcomes (2)

  • 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.

    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

  • 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.

    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 (2)

  • Conjunctival changes during dupilumab treatment using Impression Cytology

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

  • Optimal treatment of conjunctivitis

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Treatment with oral or ocular immunosuppressive drugs 2 weeks prior to start of dupilumab treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Utrecht

Utrecht, 3584CX, Netherlands

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood, tear fluid, impression cytology of the conjunctiva

MeSH Terms

Conditions

Dermatitis, AtopicConjunctivitis

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System DiseasesConjunctival DiseasesEye Diseases

Central Study Contacts

Roselie Achten, MD

CONTACT

0031 88 75 57439r.e.achten@umcutrecht.nl

Marjolein de Bruin-Weller, MD, PhD

CONTACT

m.s.debruin-weller@umcutrecht.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

February 10, 2020

First Posted

February 19, 2020

Study Start

February 25, 2020

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

November 29, 2023

Record last verified: 2023-11

Locations

NL(1)