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NCT04276623 Clinical Trial

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

Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04276623
Other study ID # 18/537
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 25, 2020
Est. completion date December 31, 2023

Study information
Verified date November 2023
Source UMC Utrecht
Contact Roselie Achten, MD
Phone 0031 88 75 57439
Email r.e.achten@umcutrecht.nl
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult patients with atopic dermatitis indicated for dupilumab, without current use of oral immunosuppressive treatment . Exclusion Criteria: - Treatment with oral or ocular immunosuppressive drugs 2 weeks prior to start of dupilumab treatment

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Netherlands University Medical Center Utrecht Utrecht

Sponsors (2)
Lead Sponsor Collaborator
UMC Utrecht Sanofi

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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 baseline, 4 weeks and 28 weeks after start dupilumab, at the moment of the development of eye symptoms, 4 weeks after ocular treatment
Secondary 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. at the moment of the development of eye symptoms, 4 weeks after ocular treatment
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