Real-world Experience on the Use of Upadacitinib in the Treatment of Moderate-severe Adult Atopic Dermatitis (ERUDA)

Atopic Dermatitis Clinical Trial

— ERUDA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05989932
• Other study ID #: SID02
• Status: Recruiting
• Start date: November 19, 2021
• Est. completion date: November 19, 2031

Study information

• Verified date: November 2023
• Source: Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse
• Contact: Ketty MD Peris
• Phone: 0630154211
• Email: ketty.peris[@]unicatt.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Real-world experience on the use of Upadacitinib in the treatment of Adult moderate-severe atopic dermatitis

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: November 19, 2031
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age 18 years

2. Signature of informed consent

3. Diagnosis of moderate and/or severe DA by a dermatologist specialist

4. Approval of the compassionate use of upadacitinib

Exclusion Criteria:

1. Patient unable to give informed consent prior to any collection procedure study data

2. unable to complete the procedures required for the study

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Other:
• Upadacitinib
Real-world on the use of Upadacitinib

Locations

Country	Name	City	State
Italy	Irccs Fondazione Policlinico Gemelli	Roma

Sponsors (1)

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

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dermatology life quality index (DLQI)	Assessment of the patient's quality of life	every 12 weeks
Primary	Patient-oriented eczema measure (POEM)	Monitoring atopic eczema severity	every 12 weeks