A Study to Evaluate the Quality of Life of Male and Female Adult Patients With Severe Refractory Atopic Dermatitis Treated With Dupilumab in Czech Republic

NCT ID: NCT05527964

Last Updated: 2025-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

146 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-30

Study Completion Date

2025-06-16

Brief Summary

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Assessment of the relationship between treatment response (EASI75) and change in quality of life (EQ-5D) by week 24.

Description of the:

* Change in disease activity after 16 and 24 weeks
* Change in subject and family quality of life after 16 and 24 weeks
* Change in sleep quality after 16 and 24 weeks
* Change in anxiety after 16 and 24 weeks
* Change in depression after 16 and 24 weeks
* Safety and tolerability

Detailed Description

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28 weeks

Conditions

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Atopic Dermatitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with severe refractory atopic dermatitis

Patients eligible for Dupixent therapy of AD

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patient eligible for Dupixent therapy of AD according to the current SPC and reimbursement criteria given by the SUKL
* Signed informed consent
* 18 years and older (study questionnaires are validated for this age group). Patient is able to follow the prescribed regimen, routine follow-up visits and to fill the questionnaires

Exclusion Criteria

\- Patient not eligible for Dupixent therapy of AD according to the current SPC and reimbursement criteria given by the SUKL.

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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Investigational Site: Bulovka University Hospital

Prague, , Czechia

Site Status

Countries

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Czechia

Other Identifiers

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U1111-1279-3216

Identifier Type: REGISTRY

Identifier Source: secondary_id

OBS17350

Identifier Type: -

Identifier Source: org_study_id

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