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

Recruiting

• Conditions: Moderate Psoriasis; Psoriasis; Moderate Plaque Psoriasis

• Registration Number: NCT06247319
• Lead Sponsor: AbbVie

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2024-01-29
• Study First Submitted QC: 2024-01-31
• Study First Posted: 2024-02-07
• Study Start: 2024-04-29
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-13
• Primary Completion: 2027-10
• Study Completion: 2027-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of participants achieving Psoriasis Area and Severity Index (PASI) score less than or equal to 2	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.
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)	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.

Trial Locations

Locations (21)

Iatriko Psichikou /ID# 272851; 🇬🇷 Athens, Attiki, Greece

University General Hospital Attikon /ID# 263442; 🇬🇷 Athens, Attiki, Greece

General Hospital Andreas Syggros /ID# 266248; 🇬🇷 Athens, Attiki, Greece

Asklipieio General Hospital of Voula /ID# 268136; 🇬🇷 Voula, Attiki, Greece

Hygeia Hospital /ID# 263455; 🇬🇷 Athens, Greece

Papageorgiou General Hospital /ID# 262529; 🇬🇷 Thessaloniki, Greece

251 Hellenic Air Force General Hospital /ID# 268135; 🇬🇷 Athens, Attiki, Greece

Tzaneio Prefecture General Hospital of Piraeus /ID# 263448; 🇬🇷 Pireas, Attiki, Greece

Konstantopoulio General Hospital /ID# 266257; 🇬🇷 Nea Ionia, Magnisia, Greece

Hospital of Skin and Venereal Diseases- Thessaloniki /ID# 262530; 🇬🇷 Thessaloniki, Greece

Hospital of Skin and Venereal Diseases- Thessaloniki /ID# 263452; 🇬🇷 Thessaloniki, Greece

General Hospital of Tripoli Panarkadiko "Evangelistria" /ID# 266251; 🇬🇷 Tripoli, Greece

General Hospital of Xanthi /ID# 268133; 🇬🇷 Xanthi, Greece

West Attica General Hospital "Agia Varvara" /ID# 266256; 🇬🇷 Agia Varvara, Greece

University General Hospital of Heraklion /ID# 268777; 🇬🇷 Heraklion, Greece

KAT Attica General Hospital /ID# 266249; 🇬🇷 Kifissia, Greece

University General Hospital of Larissa /ID# 263440; 🇬🇷 Larissa, Greece

General Hospital of Thessaloniki "Agios Pavlos'' /ID# 267506; 🇬🇷 Thessaloniki, Greece

Olympion General Clinic /ID# 266258; 🇬🇷 Patras, Achaia, Greece

General Hospital Andreas Syggros /ID# 263443; 🇬🇷 Athens, Attiki, Greece

Venizelio Regional General Hospital of Heraklion /ID# 268778; 🇬🇷 Iraklio, Irakleio, Greece