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Atopic DermatitisUPDATENCT05669794

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

An observational study of Atopic Dermatitis, run by AbbVie at 59 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Atopic Dermatitis
How many people
300 participants
Where
59 sitesFrance
Study dates
21 Feb 2023to Feb 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Adolescent and adult participants with Atopic dermatitis (AD)

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

59 sites in 1 country.

59 sites in 1 country

France59 sites

  • Hopital Nord Amiens /ID# 250300

    Amiens, 80080

  • Chu Angers /Id# 248674

    Angers, 49933

  • Hopital Prive d'Antony /ID# 247324

    Antony, Île-de-France Region, 92160

  • CH Victor Dupouy /ID# 247216

    Argenteuil, 95100

  • CH Avignon /ID# 251198

    Avignon, Vaucluse, 84902

  • CHU de Besancon - Jean Minjoz /ID# 248642

    Besançon, Doubs, 25030

  • Centre Hospitalier de Béziers /ID# 264454

    Béziers, 34525

  • Hopital Ambroise Pare /ID# 253337

    Boulogne-Billancourt, 92104

  • CHU de CAEN - Hopital de la Cote de Nacre /ID# 252127

    Caen, 14033

  • CH de Cahors /ID# 251190

    Cahors, 46005

  • Centre Hospitalier de Calais /ID# 249449

    Calais, 62100

  • Cabinet Dermatologie et Esthetique /ID# 247972

    Cannes, 06400

  • CH William Morey /ID# 256417

    Chalon-sur-Saône, 71321

  • Centre Hospitalier Métropole Savoie - Site Hôpital de Chambéry /ID# 252012

    Chambéry, Savoie, 73007

  • CHU Clermont-Ferrand /ID# 248611

    Clermont, Auvergne-Rhône-Alpes, 63100

  • Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 247209

    Créteil, Paris, 94010

  • CHU Dijon /ID# 248984

    Dijon, Cote-d Or, 21000

  • CH Annecy Genevois - Site Annecy /ID# 249024

    Epagny Metz Tessy, 74370

  • CH la Rochelle /ID# 252128

    La Rochelle, 17019

  • Centre Hospitalier du Mans /ID# 250510

    Le Mans, Sarthe, 72037

  • CH Emile Roux Le Puy en Velay /ID# 248983

    Le Puy-en-Velay, 43000

  • Hopital Saint Vincent de Paul /ID# 247218

    Lille, 59020

  • CHU Limoges - Dupuytren 2 /ID# 251224

    Limoges, 87000

  • Hopital du Scorff /ID# 251226

    Lorient, Morbihan, 56100

  • Hopital Femme Mere Enfant /ID# 258682

    Lyon, 69500

  • Hôpital Européen Marseille /ID# 257643

    Marseille, Bouches-du-Rhone, 13003

  • Hopital Saint Joseph /ID# 255537

    Marseille, Bouches-du-Rhone, 13008

  • CHU Montpellier - Hopital Saint Eloi /ID# 251877

    Montpellier, Herault, 34295

  • CHU de Nantes, Hotel Dieu -HME /ID# 262563

    Nantes, Pays de la Loire Region, 44000

  • Cideazur /ID# 247905

    Nice, 06000

  • CH Georges Renon /ID# 248976

    Niort, Deux-Sevres, 79028

  • Hopitaux Universitaires Paris Centre-Hopital Cochin /ID# 250807

    Paris, Paris, 75679

  • Hôpital Saint-Louis /ID# 251228

    Paris, 75010

  • Cabinet libéral du Dr KURIHARA /ID# 249664

    Paris, 75011

  • Hopital Bichat-Claude Bernard /ID# 251274

    Paris, 75018

  • Hopital Pitie Salpetriere /ID# 253464

    Paris, Île-de-France Region, 75013

  • CH de PAU /ID# 248567

    Pau, 64000

  • HCL - Hopital Lyon Sud /ID# 248864

    Pierre-Bénite, Rhone, 69495

  • CH Pontoise - Hopital René Dubos /ID# 248843

    Pontoise, Val-d Oise, 95300

  • Centre Hospitalier de Quimper /ID# 251119

    Quimper, Finistere, 29107

  • Polyclinique Courlancy /ID# 250476

    Reims, Marne, 51100

  • Hopital Ponchaillou /ID# 251225

    Rennes, Brittany Region, 35000

  • Hopitaux Drome Nord /ID# 248207

    Romans-sur-Isère, Drome, 26100

  • Hôpital Charles-Nicolle /ID# 247215

    Rouen, 76000

  • CHU de Rouen /ID# 250648

    Rouen, 76031

  • CHU nord - hopital Felix Guyon /ID# 250694

    Saint-Denis, Le Reunion, 97400

  • CHI POISSY - Saint-Germain-en-Laye /ID# 248612

    Saint-Germain-en-Laye, Yvelines, 78100

  • Hôpital d'instruction des armées Bégin /ID# 247751

    Saint-Mandé, 94163

  • Centre Hospitalier Saint-Nazaire /ID# 251200

    Saint-Nazaire, Loire-Atlantique, 44606

  • Ch Saint Quentin /Id# 249270

    Saint-Quentin, Aisne, 02321

  • Ch Salon de Provence /Id# 248829

    Salon-de-Provence, 13300

  • Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord /ID# 251117

    St-Priest-en-Jarez, Pays de la Loire Region, 42270

  • CHR Metz-Thionville - Hopital Bel-Air /ID# 252267

    Thionville, Moselle, 57100

  • Hôpital d'Instruction des Armées Sainte-Anne /ID# 247908

    Toulon, 83800

  • CHU Toulouse - Hopital Larrey /ID# 247219

    Toulouse, 31400

  • Hopital Nord Franche Comté /ID# 261628

    Trévenans, 90400

  • CH Valence /ID# 250693

    Valence, Drome, 26000

  • Centre Hospitalier de Valenciennes /ID# 258642

    Valenciennes, Nord, 59300

  • Cabinet Liberal /ID# 251195

    Villeurbanne, 69100

Other trials in France

About this study

Official title: 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.

Read more

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.

Keywords
Atopic dermatitis, AD, Upadacitinib, RINVOQ
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05669794
Study groupRoleWhat they receive
UpadacitinibParticipants will receive upadacitinib as prescribed by their physician according to local label.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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).

    Measured: Month 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jan 2023
  2. Study start21 Feb 2023
  3. Primary completionFeb 2027 (estimated)
  4. Study completionFeb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05669794
Sponsor's protocol ID
P23-628
Acronym
UPDATE
Status last verified
Feb 2025
First submitted
21 Dec 2022
Last updated
27 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Atopic Dermatitis, run by AbbVie at 59 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants achieving an absolute SCORing Atopic Dermatitis (SCORAD) of <25 (time frame: Month 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05669794.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.

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