NCT06247319Active, not recruiting
Study to Evaluate the Effectiveness of Risankizumab in Participants With a Recent Diagnosis of Moderate Plaque Psoriasis in a Real-life Setting in Greece
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
Source: ClinicalTrials.gov · Last updated 4 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 250 (actual)
- First submitted
- 29 Jan 2024
- Start date
- 29 Apr 2024
- Primary completion date
- Oct 2027
- Lead sponsor
- AbbVie
- Diseases
- Psoriasis
- NCT number
- NCT06247319
What you commit to
- Study type: Observational
- Participants enrolled: 250
- From 29 Apr 2024 to the primary completion date, Oct 2027
- 22 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants who currently receive treatment with any investigational drug/device/intervention or who have received any investigational product within 30 days before risankizumab initiation
Other
- Pregnancy or lactation
- Unwilling or unable to provide informed consent
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (22)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| West Attica General Hospital "Agia Varvara" /ID# 266256 Coordinator of this site? Confirm its status | Agía Varvára | Greece | Unknown status |
| General Hospital Andreas Syggros /ID# 266248 Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| 401 General Military Hospital /ID# 277393 Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| Iatriko Psichikou /ID# 272851 Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| University General Hospital Attikon /ID# 263442 Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| 251 Hellenic Air Force General Hospital /ID# 268135 Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| Hygeia Hospital /ID# 263455 Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| General Hospital Andreas Syggros /ID# 263443 Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| Venizelio Regional General Hospital of Heraklion /ID# 268778 Coordinator of this site? Confirm its status | Heraklion | Greece | Unknown status |
| University General Hospital of Heraklion /ID# 268777 Coordinator of this site? Confirm its status | Heraklion | Greece | Unknown status |
| KAT Attica General Hospital /ID# 266249 Coordinator of this site? Confirm its status | Kifissia | Greece | Unknown status |
| University General Hospital of Larissa /ID# 263440 Coordinator of this site? Confirm its status | Larissa | Greece | Unknown status |
| Konstantopoulio General Hospital /ID# 266257 Coordinator of this site? Confirm its status | Nea Ionia | Greece | Unknown status |
| Olympion General Clinic /ID# 266258 Coordinator of this site? Confirm its status | Pátrai | Greece | Unknown status |
| Tzaneio Prefecture General Hospital of Piraeus /ID# 263448 Coordinator of this site? Confirm its status | Piraeus | Greece | Unknown status |
| Hospital of Skin and Venereal Diseases- Thessaloniki /ID# 262530 Coordinator of this site? Confirm its status | Thessaloniki | Greece | Unknown status |
| Hospital of Skin and Venereal Diseases- Thessaloniki /ID# 263452 Coordinator of this site? Confirm its status | Thessaloniki | Greece | Unknown status |
| Papageorgiou General Hospital /ID# 262529 Coordinator of this site? Confirm its status | Thessaloniki | Greece | Unknown status |
| General Hospital of Thessaloniki "Agios Pavlos'' /ID# 267506 Coordinator of this site? Confirm its status | Thessaloniki | Greece | Unknown status |
| General Hospital of Tripoli Panarkadiko "Evangelistria" /ID# 266251 Coordinator of this site? Confirm its status | Tripoli | Greece | Unknown status |
| Asklipieio General Hospital of Voula /ID# 268136 Coordinator of this site? Confirm its status | Voula | Greece | Unknown status |
| General Hospital of Xanthi /ID# 268133 Coordinator of this site? Confirm its status | Xánthi | Greece | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.