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 (UPDATE)

February 26, 2025 updated by: AbbVie

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80080
        • Hopital Nord Amiens /ID# 250300
      • Angers, France, 49933
        • Chu Angers /Id# 248674
      • Argenteuil, France, 95100
        • CH Victor Dupouy /ID# 247216
      • Boulogne Billancourt, France, 92104
        • Hopital Ambroise Pare /ID# 253337
      • Béziers, France, 34525
        • Centre Hospitalier de Béziers /ID# 264454
      • Caen, France, 14033
        • CHU de CAEN - Hopital de la Cote de Nacre /ID# 252127
      • Cahors CEDEX 9, France, 46005
        • CH de Cahors /ID# 251190
      • Calais, France, 62100
        • Centre Hospitalier de Calais /ID# 249449
      • Cannes, France, 06400
        • Cabinet Dermatologie et Esthetique /ID# 247972
      • Chalon Sur Saone, France, 71321
        • CH William Morey /ID# 256417
      • Epagny Metz Tessy, France, 74370
        • CH Annecy Genevois - Site Annecy /ID# 249024
      • La Rochelle CEDEX 1, France, 17019
        • CH la Rochelle /ID# 252128
      • Le Puy en Velay, France, 43000
        • CH Emile Roux Le Puy en Velay /ID# 248983
      • Lille Cedex, France, 59020
        • Hopital Saint Vincent de Paul /ID# 247218
      • Limoges, France, 87000
        • CHU Limoges - Dupuytren 2 /ID# 251224
      • Lyon, France, 69500
        • Hopital Femme Mere Enfant /ID# 258682
      • Nice, France, 06000
        • Cideazur /ID# 247905
      • Paris, France, 75011
        • Cabinet libéral du Dr KURIHARA /ID# 249664
      • Paris, France, 75010
        • Hôpital Saint-Louis /ID# 251228
      • Paris, France, 75018
        • Hopital Bichat-Claude Bernard /ID# 251274
      • Pau, France, 64000
        • CH de PAU /ID# 248567
      • Rouen, France, 76000
        • Hôpital Charles-Nicolle /ID# 247215
      • Rouen CEDEX, France, 76031
        • CHU de Rouen /ID# 250648
      • Saint-Mandé cedex, France, 94163
        • Hôpital d'instruction des armées Bégin /ID# 247751
      • Salon de Provence, France, 13300
        • Ch Salon de Provence /Id# 248829
      • Toulon CEDEX 9, France, 83800
        • Hôpital d'Instruction des Armées Sainte-Anne /ID# 247908
      • Toulouse, France, 31400
        • CHU Toulouse - Hopital Larrey /ID# 247219
      • Trevenans, France, 90400
        • Hopital Nord Franche Comté /ID# 261628
      • Villeurbanne, France, 69100
        • Cabinet Liberal /ID# 251195
    • Aisne
      • St Quentin CEDEX, Aisne, France, 02321
        • Ch Saint Quentin /Id# 249270
    • Auvergne-Rhone-Alpes
      • Clermont, Auvergne-Rhone-Alpes, France, 63100
        • CHU Clermont-Ferrand /ID# 248611
    • Bouches-du-Rhone
      • Marseille, Bouches-du-Rhone, France, 13003
        • Hôpital Européen Marseille /ID# 257643
      • Marseille, Bouches-du-Rhone, France, 13008
        • Hopital Saint Joseph /ID# 255537
    • Bretagne
      • Rennes, Bretagne, France, 35000
        • Hopital Ponchaillou /ID# 251225
    • Cote-d Or
      • Dijon, Cote-d Or, France, 21000
        • CHU Dijon /ID# 248984
    • Deux-Sevres
      • Niort CEDEX, Deux-Sevres, France, 79028
        • CH Georges Renon /ID# 248976
    • Doubs
      • Besancon, Doubs, France, 25030
        • CHU de Besancon - Jean Minjoz /ID# 248642
    • Drome
      • Romans Sur Isere, Drome, France, 26100
        • Hopitaux Drome Nord /ID# 248207
      • Valence, Drome, France, 26000
        • CH Valence /ID# 250693
    • Finistere
      • Quimper CEDEX, Finistere, France, 29107
        • Centre Hospitalier de Quimper /ID# 251119
    • Herault
      • Montpellier Cedex 5, Herault, France, 34295
        • CHU Montpellier - Hopital Saint Eloi /ID# 251877
    • Ile-de-France
      • Antony, Ile-de-France, France, 92160
        • Hopital Prive d'Antony /ID# 247324
      • Paris, Ile-de-France, France, 75013
        • Hopital Pitie Salpetriere /ID# 253464
    • Le Reunion
      • St Denis, Le Reunion, France, 97400
        • CHU nord - hopital Felix Guyon /ID# 250694
    • Loire
      • St-Priest-en-Jarez, Loire, France, 42270
        • Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord /ID# 251117
    • Loire-Atlantique
      • Saint-Nazaire, Loire-Atlantique, France, 44606
        • Centre Hospitalier Saint-Nazaire /ID# 251200
    • Marne
      • Reims, Marne, France, 51100
        • Polyclinique Courlancy /ID# 250476
    • Morbihan
      • Lorient, Morbihan, France, 56100
        • Hopital du Scorff /ID# 251226
    • Moselle
      • Thionville, Moselle, France, 57100
        • CHR Metz-Thionville - Hopital Bel-Air /ID# 252267
    • Nord
      • Valenciennes, Nord, France, 59300
        • Centre Hospitalier de Valenciennes /ID# 258642
    • Paris
      • Creteil, Paris, France, 94010
        • Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 247209
      • Paris CEDEX 14, Paris, France, 75679
        • Hopitaux Universitaires Paris Centre-Hopital Cochin /ID# 250807
    • Pays-de-la-Loire
      • Nantes, Pays-de-la-Loire, France, 44000
        • CHU de Nantes, Hotel Dieu -HME /ID# 262563
    • Rhone
      • Pierre Benite CEDEX, Rhone, France, 69495
        • HCL - Hopital Lyon Sud /ID# 248864
    • Sarthe
      • Le Mans CEDEX 9, Sarthe, France, 72037
        • Centre Hospitalier du Mans /ID# 250510
    • Savoie
      • Chambery CEDEX, Savoie, France, 73007
        • Centre Hospitalier Métropole Savoie - Site Hôpital de Chambéry /ID# 252012
    • Val-d Oise
      • Pontoise, Val-d Oise, France, 95300
        • CH Pontoise - Hopital René Dubos /ID# 248843
    • Vaucluse
      • Avignon, Vaucluse, France, 84902
        • CH Avignon /ID# 251198
    • Yvelines
      • St Germain en Laye, Yvelines, France, 78100
        • CHI POISSY - Saint-Germain-en-Laye /ID# 248612

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adolescent and adult participants with Atopic dermatitis (AD)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Upadacitinib
Participants will receive upadacitinib as prescribed by their physician according to local label.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Month 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2023

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

December 21, 2022

First Submitted That Met QC Criteria

December 21, 2022

First Posted (Actual)

January 3, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 26, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P23-628

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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