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

Last updated: April 10, 2025
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

N/A

Condition

Rosacea

Warts

Skin Wounds

Treatment

N/A

Clinical Study ID

NCT06247319
P24-179
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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, anddeucravacitinib)

  • Participants who have been prescribed treatment with risankizumab in line withmarketing authorization and local access conditions, prior to signed InformedConsent

  • Decision to treat with risankizumab has been made independently and prior toenrolment in the study

  • Participants must be willing and able to read and complete the study specificquestionnaires

Exclusion

Exclusion Criteria:

  • Participants who currently receive treatment with any investigationaldrug/device/intervention or who have received any investigational product within 30days before risankizumab initiation

  • Pregnancy or lactation

  • Unwilling or unable to provide informed consent

Study Design

Total Participants: 250
Study Start date:
April 29, 2024
Estimated Completion Date:
October 31, 2027

Study Description

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

Connect with a study center

  • Olympion General Clinic /ID# 266258

    Patras, Achaia 25443
    Greece

    Active - Recruiting

  • 251 Hellenic Air Force General Hospital /ID# 268135

    Athens, Attiki 11527
    Greece

    Active - Recruiting

  • General Hospital Andreas Syggros /ID# 263443

    Athens, Attiki 16121
    Greece

    Active - Recruiting

  • General Hospital Andreas Syggros /ID# 266248

    Athens, Attiki 16121
    Greece

    Active - Recruiting

  • Iatriko Psichikou /ID# 272851

    Athens, Attiki 11525
    Greece

    Active - Recruiting

  • University General Hospital Attikon /ID# 263442

    Athens, Attiki 12462
    Greece

    Active - Recruiting

  • Tzaneio Prefecture General Hospital of Piraeus /ID# 263448

    Pireas, Attiki 18536
    Greece

    Active - Recruiting

  • Asklipieio General Hospital of Voula /ID# 268136

    Voula, Attiki 16673
    Greece

    Active - Recruiting

  • Venizelio Regional General Hospital of Heraklion /ID# 268778

    Iraklio, Irakleio 71409
    Greece

    Active - Recruiting

  • Konstantopoulio General Hospital /ID# 266257

    Nea Ionia, Magnisia 14233
    Greece

    Active - Recruiting

  • West Attica General Hospital "Agia Varvara" /ID# 266256

    Agia Varvara, 12351
    Greece

    Active - Recruiting

  • Dermatological and Venereological Hospital Andreas Syggros /ID# 263443

    Athens, 16121
    Greece

    Active - Recruiting

  • Dermatological and Venereological Hospital Andreas Syggros /ID# 266248

    Athens, 16121
    Greece

    Active - Recruiting

  • Hygeia Hospital /ID# 263455

    Athens, 15123
    Greece

    Active - Recruiting

  • University General Hospital of Heraklion /ID# 268777

    Heraklion, 71500
    Greece

    Active - Recruiting

  • KAT Attica General Hospital /ID# 266249

    Kifissia, 14561
    Greece

    Active - Recruiting

  • University General Hospital of Larissa /ID# 263440

    Larissa, 41110
    Greece

    Active - Recruiting

  • General Hospital of Thessaloniki "Agios Pavlos'' /ID# 267506

    Thessaloniki, 55134
    Greece

    Active - Recruiting

  • Hospital of Skin and Venereal Diseases- Thessaloniki /ID# 262530

    Thessaloniki, 54643
    Greece

    Active - Recruiting

  • Hospital of Skin and Venereal Diseases- Thessaloniki /ID# 263452

    Thessaloniki, 54643
    Greece

    Active - Recruiting

  • Papageorgiou General Hospital /ID# 262529

    Thessaloniki, 56429
    Greece

    Active - Recruiting

  • General Hospital of Tripoli Panarkadiko "Evangelistria" /ID# 266251

    Tripoli, 22100
    Greece

    Active - Recruiting

  • General Hospital of Xanthi /ID# 268133

    Xanthi, 67100
    Greece

    Active - Recruiting

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