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

NCT06247319 | Active Not Recruiting

• 1 other identifier: P24-179
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 22

Brief 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.

Conditions

Moderate Psoriasis; Psoriasis; Moderate Plaque Psoriasis

Keywords

Moderate Psoriasis; Psoriasis; Moderate Plaque Psoriasis

Outcome Measures

Primary Outcomes (2)

• Proportion of participants achieving Psoriasis Area and Severity Index (PASI) score less than or equal to 2

  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)

  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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (22)

Olympion General Clinic /ID# 266258

Pátrai, Achaia, 25443, Greece

Location

Iatriko Psichikou /ID# 272851

Athens, Attica, 11525, Greece

Location

251 Hellenic Air Force General Hospital /ID# 268135

Athens, Attica, 11527, Greece

Location

University General Hospital Attikon /ID# 263442

Athens, Attica, 12462, Greece

Location

General Hospital Andreas Syggros /ID# 263443

Athens, Attica, 16121, Greece

Location

General Hospital Andreas Syggros /ID# 266248

Athens, Attica, 16121, Greece

Location

Tzaneio Prefecture General Hospital of Piraeus /ID# 263448

Piraeus, Attica, 18536, Greece

Location

Asklipieio General Hospital of Voula /ID# 268136

Voula, Attica, 16673, Greece

Location

University General Hospital of Heraklion /ID# 268777

Heraklion, Crete, 71500, Greece

Location

Venizelio Regional General Hospital of Heraklion /ID# 268778

Heraklion, Irakleio, 71409, Greece

Location

Konstantopoulio General Hospital /ID# 266257

Nea Ionia, Magnisia, 14233, Greece

Location

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

Agía Varvára, 12351, Greece

Location

401 General Military Hospital /ID# 277393

Athens, 11525, Greece

Location

Hygeia Hospital /ID# 263455

Athens, 15123, Greece

Location

KAT Attica General Hospital /ID# 266249

Kifissia, 14561, Greece

Location

University General Hospital of Larissa /ID# 263440

Larissa, 41110, Greece

Location

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

Thessaloniki, 54643, Greece

Location

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

Thessaloniki, 54643, Greece

Location

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

Thessaloniki, 55134, Greece

Location

Papageorgiou General Hospital /ID# 262529

Thessaloniki, 56429, Greece

Location

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

Tripoli, 22100, Greece

Location

General Hospital of Xanthi /ID# 268133

Xánthi, 67100, Greece

Location

Related Links

• Related Info

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 7, 2024
• Study Start: April 29, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: February 4, 2026

Record last verified: 2026-02

Locations

GR (22)