Study to Evaluate the Effectiveness of Risankizumab in Participants With a Recent Diagnosis of Moderate Plaque Psoriasis in a Real-life Setting in Greece (REDEFINE)

February 2, 2026 updated by: AbbVie

A Non-interventional, Prospective Study to Evaluate the Effectiveness of Risankizumab in Patients With Recent Diagnosis of Moderate Plaque Psoriasis in a Real Life Setting in Greece- the REDEFINE Study

Psoriasis is a skin disorder wherein skin cells multiply faster than normal, making the skin itchy and look patchy and red. It is caused by an overactive immune system where the body attacks healthy tissue by mistake. The impact of Psoriasis on quality of life can be significant, especially in moderate-to-severe disease which affects approximately half of the participants with plaque Psoriasis. Participants with Psoriasis are marked by their disease physically, psychologically, and emotionally. In addition to the above, their disease exerts a negative effect on various dimensions of health-related quality of life such as daily activities and work productivity. This study is designed to provide information regarding the impact of risankizumab on short-term and long-term clinical parameters of Psoriasis as well as the patient-reported outcomes (PROs) in participants with a recent diagnosis (less than or equal to 24 months) of moderate Psoriasis who are naïve to advanced treatments.

Risankizumab is an approved drug for the treatment of Plaque Psoriasis. Approximately 250 participants with a recent diagnosis of moderate plaque psoriasis (defined as less than or equal to 24 months since the first diagnosis of moderate Psoriasis), and naïve to advanced treatments (biologics, apremilast, and deucravacitinib) will be enrolled at approximately 20 sites in Greece.

Participants will receive risankizumab as prescribed by their treating dermatologist in accordance with local authorization and independently from the study. Participants will be enrolled and observed for approximately two years.

There is expected to be no additional burden for participants in this trial. Study visits comprised of private practices and hospital clinics as per standard of care.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

Any of a variety of other sampling processes, such as convenience sampling or invitation to volunteer.

Study Type

Observational

Enrollment (Actual)

250

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

  • Greece
      • Agía Varvára, Greece, 12351
        • West Attica General Hospital "Agia Varvara" /ID# 266256
      • Athens, Greece, 11525
        • 401 General Military Hospital /ID# 277393
      • Athens, Greece, 15123
        • Hygeia Hospital /ID# 263455
      • Kifissia, Greece, 14561
        • KAT Attica General Hospital /ID# 266249
      • Larissa, Greece, 41110
        • University General Hospital of Larissa /ID# 263440
      • Thessaloniki, Greece, 54643
        • Hospital of Skin and Venereal Diseases- Thessaloniki /ID# 262530
      • Thessaloniki, Greece, 54643
        • Hospital of Skin and Venereal Diseases- Thessaloniki /ID# 263452
      • Thessaloniki, Greece, 55134
        • General Hospital of Thessaloniki "Agios Pavlos'' /ID# 267506
      • Thessaloniki, Greece, 56429
        • Papageorgiou General Hospital /ID# 262529
      • Tripoli, Greece, 22100
        • General Hospital of Tripoli Panarkadiko "Evangelistria" /ID# 266251
      • Xánthi, Greece, 67100
        • General Hospital of Xanthi /ID# 268133
    • Achaia
      • Pátrai, Achaia, Greece, 25443
        • Olympion General Clinic /ID# 266258
    • Attica
      • Athens, Attica, Greece, 11525
        • Iatriko Psichikou /ID# 272851
      • Athens, Attica, Greece, 11527
        • 251 Hellenic Air Force General Hospital /ID# 268135
      • Athens, Attica, Greece, 12462
        • University General Hospital Attikon /ID# 263442
      • Athens, Attica, Greece, 16121
        • General Hospital Andreas Syggros /ID# 263443
      • Athens, Attica, Greece, 16121
        • General Hospital Andreas Syggros /ID# 266248
      • Piraeus, Attica, Greece, 18536
        • Tzaneio Prefecture General Hospital of Piraeus /ID# 263448
      • Voula, Attica, Greece, 16673
        • Asklipieio General Hospital of Voula /ID# 268136
    • Crete
      • Heraklion, Crete, Greece, 71500
        • University General Hospital of Heraklion /ID# 268777
    • Irakleio
      • Heraklion, Irakleio, Greece, 71409
        • Venizelio Regional General Hospital of Heraklion /ID# 268778
    • Magnisia
      • Nea Ionia, Magnisia, Greece, 14233
        • Konstantopoulio General Hospital /ID# 266257

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants with a recent diagnosis of moderate plaque PsO (defined as ≤24 months since the first diagnosis of moderate PsO), and naïve to advanced treatments (biologics, apremilast, and deucravacitinib) treated with Risakizumab according to local label.

Description

Inclusion Criteria:

  • Participants with a confirmed diagnosis of moderate plaque PsO made by a specialist ≤24 months prior to risankizumab prescription defined as:

    • Percentage of body surface affected by PsO Body Surface Area (BSA) >2% and <20%
    • Psoriasis Area and Severity Index (PASI) score >10
    • Static Physician's Global Assessment (sPGA) score =3 (moderate) based on a 5-point scale (0-4)
  • Participants naïve to advanced treatments (biologics, apremilast, and deucravacitinib)
  • Participants who have been prescribed treatment with risankizumab in line with marketing authorization and local access conditions, prior to signed Informed Consent
  • Decision to treat with risankizumab has been made independently and prior to enrolment in the study
  • Participants must be willing and able to read and complete the study specific questionnaires

Exclusion Criteria:

  • Participants who currently receive treatment with any investigational drug/device/intervention or who have received any investigational product within 30 days before risankizumab initiation
  • Pregnancy or lactation
  • Unwilling or unable to provide informed consent

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

Cohorts and Interventions

Group / Cohort
Participants Treated with Risankizumab
Participants with a recent diagnosis of moderate plaque PsO (defined as ≤24 months since the first diagnosis of moderate PsO), and naïve to advanced treatments (biologics, apremilast, and deucravacitinib) will receive risankizumab as prescribed by their physician according to local label.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants achieving Psoriasis Area and Severity Index (PASI) score less than or equal to 2
Time Frame: Baseline to Week 16
The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis.
Baseline to Week 16
Proportion of participants achieving a Dermatology Life Quality Index (DLQI) score of 0 or 1 (include only patients with DLQI score less than or equal to 2 at Baseline)
Time Frame: Baseline to Week 16
DLQI (Dermatology Life Quality Index) assesses symptoms and impacts of dermatologic diseases on quality of life. DLQI scores range from 0 (no effect) to 30 (very large effect), with a higher score indicating a more impaired quality of life.
Baseline to Week 16

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)

April 29, 2024

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

January 29, 2024

First Submitted That Met QC Criteria

January 31, 2024

First Posted (Actual)

February 7, 2024

Study Record Updates

Last Update Posted (Actual)

February 4, 2026

Last Update Submitted That Met QC Criteria

February 2, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P24-179

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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