Home
Clinical Trials
Effectiveness of Dupilumab in...

Effectiveness of Dupilumab in Food Allergic Patients With Moderate to Severe Atopic Dermatitis

NCT ID: NCT04462055

Last Updated: 2022-07-29

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

3 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-01

Study Completion Date

2022-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study evaluates the effectiveness of Dupilumab in food allergic patients with moderate to severe Atopic Dermatitis (AD). Included patients participated in the BioDay Registry.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy and Safety of Dupilumab in Participants ≥12 to <18 Years of Age, With Moderate-to-severe Atopic Dermatitis

NCT03054428

Moderate-to-Severe Atopic Dermatitis Dermatitis, Dermatitis Atopic Eczema, Skin Diseases, Skin +6 more

COMPLETED PHASE3

Dupilumab Phase 4 Study

NCT03411837

Atopic Dermatitis

TERMINATED

The Impact of Dupilumab on Quality of Life in Moderate to Severe Atopic Dermatitis Patients

NCT03667014

Atopic Dermatitis Atopic Dermatitis Eczema

COMPLETED PHASE4

Open-Label Extension Study of Upadacitinib in Adult Participants With Moderate to Severe Atopic Dermatitis

NCT04195698

Atopic Dermatitis

COMPLETED PHASE3

Study to Determine the Safety and Effectiveness of Dupilumab for Treatment of Atopic Dermatitis (AD)

NCT01979016

Atopic Dermatitis (AD)

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The positive results of the dupilumab studies in AD, asthma and nasal polyposis with chronic sinusitis validate the fundamental role for IL-4 and IL-13 in the pathogenesis of these diseases, and add to the possibility that these cytokines are also critically involved in other related allergic/atopic (type 2 immune) diseases that are often co-morbidly associated with AD, such as food allergy.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Food Allergy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. AD patients with moderate to severe AD who are indicated for treatment with dupilumab
2. Peanut, hazelnut, walnut, cow's milk, hen's egg and/or soybean allergy allergic subjects, with a well-documented medical history of reactions after ingestion.Peanut, hazelnut, walnut, cow's milk, hen's egg and/or soybean allergy specific immunoglobulin E (IgE) level (Phadia CAP-system) higher than 0.35 kU/L or a skin prick test of at least 3 mm
3. Positive double-blind placebo-controlled Food Challenge (DBPCFC) with an eliciting dose before the last dose
4. Signed Bioday informed consent from subjects