An Observational Study to Assess Change in Disease Activity and Use of Upadacitinib Tablets in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis in Real World

Active, not recruiting

• Conditions: Atopic Dermatitis

• Registration Number: NCT05669794
• Lead Sponsor: AbbVie

Brief Summary

Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. This study will assess how effective upadacitinib is in treating AD.

Upadacitinib is an approved drug for treating AD. Approximately 300 adolescent and adult participants who are prescribed upadacitinib by their physician in accordance with local label will be enrolled in France.

Participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed up for approximately 24 months per participant and 30 days after last treatment dose for safety data collection.

There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-21
• Study First Submitted QC: 2022-12-21
• Study First Posted: 2023-01-03
• Study Start: 2023-02-21
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-02-27
• Primary Completion: 2027-02
• Study Completion: 2027-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Physician confirmed diagnosis of atopic dermatitis or atopic eczema at baseline.
• Symptom onset ≥1 year prior to baseline.
• Initiation of upadacitinib treatment for AD is indicated and prescribed per local label.
• The decision to prescribe upadacitinib is made prior to and independently of study participation.
• Participants who can understand and who are willing and able to complete the questionnaires, with parental support as required for adolescents.
• Participants (or legal representatives for adolescents) with a smartphone/tablet with internet access and willing to download the dedicated application to complete the questionnaires via this application.
• Participants (and legal representatives for adolescents) who have been informed verbally and in writing about this study before inclusion, and who do not object to their data being processed.
• Participants (and legal representatives for adolescents) able to understand and communicate with the investigator.

Exclusion Criteria

• Participation in a clinical trial assessing an investigational drug, concurrently or within the last 30 days.
• Prior treatment with upadacitinib.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants achieving an absolute SCORing Atopic Dermatitis (SCORAD) of <25	Month 4	SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as a percentage of the whole body (0-100%). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst).

Trial Locations

Locations (59)

Ch Saint Quentin /Id# 249270; 🇫🇷 St Quentin CEDEX, Aisne, France

CHU Clermont-Ferrand /ID# 248611; 🇫🇷 Clermont, Auvergne-Rhone-Alpes, France

Hôpital Européen Marseille /ID# 257643; 🇫🇷 Marseille, Bouches-du-Rhone, France

Hopital Saint Joseph /ID# 255537; 🇫🇷 Marseille, Bouches-du-Rhone, France

Hopital Ponchaillou /ID# 251225; 🇫🇷 Rennes, Bretagne, France

CHU Dijon /ID# 248984; 🇫🇷 Dijon, Cote-d Or, France

CH Georges Renon /ID# 248976; 🇫🇷 Niort CEDEX, Deux-Sevres, France

CHU de Besancon - Jean Minjoz /ID# 248642; 🇫🇷 Besancon, Doubs, France

Hopitaux Drome Nord /ID# 248207; 🇫🇷 Romans Sur Isere, Drome, France

CH Valence /ID# 250693; 🇫🇷 Valence, Drome, France

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