Moderate Plaque PsoriasisREDEFINENCT06247319
Study to Evaluate the Effectiveness of Risankizumab in Participants With a Recent Diagnosis of Moderate Plaque Psoriasis in a Real-life Setting in Greece
An observational study of Moderate Plaque Psoriasis and Moderate Psoriasis, run by AbbVie at 22 sites in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate Plaque Psoriasis, Moderate Psoriasis, Psoriasis
- How many people
- 250 participants
- Where
- 22 sitesGreece
- Study dates
- 29 Apr 2024to Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
Greece22 sites
West Attica General Hospital "Agia Varvara" /ID# 266256
Agía Varvára, 12351
Iatriko Psichikou /ID# 272851
Athens, Attica, 11525
251 Hellenic Air Force General Hospital /ID# 268135
Athens, Attica, 11527
University General Hospital Attikon /ID# 263442
Athens, Attica, 12462
General Hospital Andreas Syggros /ID# 263443
Athens, Attica, 16121
General Hospital Andreas Syggros /ID# 266248
Athens, Attica, 16121
401 General Military Hospital /ID# 277393
Athens, 11525
Hygeia Hospital /ID# 263455
Athens, 15123
University General Hospital of Heraklion /ID# 268777
Heraklion, Crete, 71500
Venizelio Regional General Hospital of Heraklion /ID# 268778
Heraklion, Irakleio, 71409
KAT Attica General Hospital /ID# 266249
Kifissia, 14561
University General Hospital of Larissa /ID# 263440
Larissa, 41110
Konstantopoulio General Hospital /ID# 266257
Nea Ionia, Magnisia, 14233
Olympion General Clinic /ID# 266258
Pátrai, Achaia, 25443
Tzaneio Prefecture General Hospital of Piraeus /ID# 263448
Piraeus, Attica, 18536
Hospital of Skin and Venereal Diseases- Thessaloniki /ID# 262530
Thessaloniki, 54643
Hospital of Skin and Venereal Diseases- Thessaloniki /ID# 263452
Thessaloniki, 54643
General Hospital of Thessaloniki "Agios Pavlos'' /ID# 267506
Thessaloniki, 55134
Papageorgiou General Hospital /ID# 262529
Thessaloniki, 56429
General Hospital of Tripoli Panarkadiko "Evangelistria" /ID# 266251
Tripoli, 22100
Asklipieio General Hospital of Voula /ID# 268136
Voula, Attica, 16673
General Hospital of Xanthi /ID# 268133
Xánthi, 67100
About this study
Official title: 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.
Read more
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.
Read the detailed description
Any of a variety of other sampling processes, such as convenience sampling or invitation to volunteer.
- Conditions
- Moderate Plaque Psoriasis, Moderate Psoriasis, Psoriasis
- Keywords
- Moderate Psoriasis, Psoriasis, Moderate Plaque Psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline to Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start29 Apr 2024
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate Plaque PsoriasisStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06247319
- Sponsor's protocol ID
- P24-179
- Acronym
- REDEFINE
- Status last verified
- Feb 2026
- First submitted
- 29 Jan 2024
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06247319
- Acronym / sponsor ID
- REDEFINE / P24-179
- Conditions
- Moderate Plaque Psoriasis, Moderate Psoriasis, Psoriasis
- Keywords
- Moderate Psoriasis, Psoriasis, Moderate Plaque Psoriasis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 29 Apr 2024 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 7 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- Participants with a confirmed diagnosis of moderate plaque PsO made by a specialist ≤24 months prior to risankizumab prescription defined as:
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Moderate Plaque Psoriasis
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of CS32582 in Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis
Not yet recruitingPhase 3
A Study of Zasocitinib in Adults With Non-pustular Palmoplantar Psoriasis
Palmoplantar Psoriasis
RecruitingPhase 4
A Study to Investigate the Effectiveness of Tirzepatide (LY3298176) Following Initiation of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque PsO and Obesity or Overweight in Clinical Practice (TOGETHER AMPLIFY-PsO)
Psoriasis, Overweight or Obesity
Active, not recruitingPhase 3
A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Moderate Plaque Psoriasis and Moderate Psoriasis, run by AbbVie at 22 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants achieving Psoriasis Area and Severity Index (PASI) score less than or equal to 2 (time frame: Baseline to Week 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.