Real-world Experience on the Use of Upa… | Clinical Trial

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

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Irccs Fondazione Policlinico Gemelli

Roma, ROMA, 00168, Italy

About this study

Atopic dermatitis (DA) is a chronic-recurrent inflammatory skin disease with high prevalence in children. Clinical remission is frequently observed during or after childhood although it may persist and/or recur, even after long and transient remission, in adulthood. In addition, in some patients the DA begins in adulthood: in these cases, we speak of DA adult-onset. In addition to the diagnostic framework, it is also important in clinical practice to assess the severity of the disease on which the choice of treatment is based, which will also take into account other factors such as: possible comorbidities, Previously performed therapies and patient needs. For the management of moderate-severe forms of atopic dermatitis topical drugs, phototherapy, traditional immunomodulating drugs and a biological drug are currently available. Compared to other chronic inflammatory skin diseases the therapeutic paraphernalia should be considered limited, with most systemic drugs that have no indication for the treatment of DA (off-label use).

In the pipeline there are numerous drugs that have reached an advanced stage of development. These include upadacitinib, a new-generation oral drug (small molecule) that selectively inhibits the signal mediated by Janus kinases 1 (JAK-1), has recently received approval for treatment of DA by EMA and AIFA to begin compassionate use of patients deemed contraindicated, intolerant, and/or non-responsive to traditional systemic therapies and biological therapy.

Evaluation of the effectiveness of upadacitinib using the EASI score Secondary objectives
Evaluation of the safety profile of upadacitinib
Predictive factors of treatment response
Assessment of patient quality of life

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Age 18 years
Signature of informed consent
Diagnosis of moderate and/or severe DA by a dermatologist specialist
Approval of the compassionate use of upadacitinib

Exclusion criteria

Patient unable to give informed consent prior to any collection procedure study data
unable to complete the procedures required for the study

Treatment and study plan

Upadacitinib

Other

Real-world on the use of Upadacitinib

Primary outcomes

Dermatology life quality index (DLQI)

Time frame: from enrollment up to 48 weeks

Assessment of the patient's quality of life. There are 10 questions, covering the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, treatment. Each question refers to the impact of the skin disease on the patient's life over the previous week. Each question is scored from 0 to 3, giving a possible score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life) --> 0-1 = No effect on patient's life, 2-5 = Small effect, 6-10 = Moderate effect, 11-20 = Very large effect, 21-30 = Extremely large effect
Patient-oriented eczema measure (POEM)

Time frame: From enrollment up to 48 weeks

The Patient Oriented Eczema Measure (POEM) is a simple, validated self-report questionnaire used for monitoring atopic eczema severity. It records seven symptoms shown to be important to patients, like itchy, sleep, bleeding ect.. Each of the seven questions carries equal weight and is scored from 0 to 4 as follows: No days = 0; 1-2 days = 1; 3-4 days = 2; 5-6 days = 3; Every day = 4. The meaning is: 0 to 2 = Clear or almost clear; 3 to 7 = Mild eczema; 8 to 16 = Moderate eczema; 17 to 24 = Severe eczema; 25 to 28 = Very severe eczema.

Sponsors and collaborators

Lead sponsor

Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse

Other

Registry information

Official study title

Esperienza Real-world Sull'Uso di Upadacitinib Nel Trattamento Della Dermatite Atopica Moderata-severa Dell'Adulto

Acronym: ERUDA

Important dates

Study start: 2021
Primary completion: 2024
Study completion: 2024
First posted: Aug 14, 2023
Registry last updated: Jul 17, 2025

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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Completed