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NCT Number: NCT05669794

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ch Saint Quentin /Id# 249270, Saint-Quentin, Aisne, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Percentage of Participants achieving an absolute SCORing Atopic Dermatitis (SCORAD) of <25

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

Real-world Effectiveness and Use of UPaDAcitinib in Patients With moderaTE-to-severe Atopic Dermatitis

Acronym: UPDATE

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jan 3, 2023
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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