MedDataX Logo

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

NCT ID: NCT06247319

Last Updated: 2026-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-29

Study Completion Date

2027-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Learn How Safe and Effective Risankizumab is When Compared to Deucravacitinib to Treat Participants With Moderate Plaque Psoriasis and Who Need to Try Systemic Treatment (Works Throughout the Whole Body)

NCT06333860

Moderate Plaque Psoriasis
ACTIVE_NOT_RECRUITING PHASE4

Study of Subcutaneous (Injected Under the Skin) Risankizumab to Assess Change in Disease Symptoms in Adult Participants With Moderate to Severe Plaque Psoriasis With Palmoplantar Involvement

NCT04713592

Psoriasis
COMPLETED PHASE3

BI 655066 / ABBV-066 (Risankizumab) in Moderate to Severe Plaque Psoriasis With Randomized Withdrawal and Re-treatment

NCT02672852

Psoriasis
COMPLETED PHASE3

BI 655066 (Risankizumab) Compared to Placebo in Japanese Patients With Moderate to Severe Chronic Plaque Psoriasis

NCT03000075

Psoriasis
COMPLETED PHASE2

Risankizumab Versus Secukinumab for Participants With Moderate to Severe Plaque Psoriasis

NCT03478787

Psoriasis
COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Moderate Plaque Psoriasis Moderate Psoriasis Psoriasis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Olympion General Clinic /ID# 266258

Pátrai, Achaia, Greece

Site Status

Iatriko Psichikou /ID# 272851

Athens, Attica, Greece

Site Status

251 Hellenic Air Force General Hospital /ID# 268135

Athens, Attica, Greece

Site Status

University General Hospital Attikon /ID# 263442

Athens, Attica, Greece

Site Status

General Hospital Andreas Syggros /ID# 263443

Athens, Attica, Greece

Site Status

General Hospital Andreas Syggros /ID# 266248

Athens, Attica, Greece

Site Status

Tzaneio Prefecture General Hospital of Piraeus /ID# 263448

Piraeus, Attica, Greece

Site Status

Asklipieio General Hospital of Voula /ID# 268136

Voula, Attica, Greece

Site Status

University General Hospital of Heraklion /ID# 268777

Heraklion, Crete, Greece

Site Status

Venizelio Regional General Hospital of Heraklion /ID# 268778

Heraklion, Irakleio, Greece

Site Status

Konstantopoulio General Hospital /ID# 266257

Nea Ionia, Magnisia, Greece

Site Status

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

Agía Varvára, , Greece

Site Status

401 General Military Hospital /ID# 277393

Athens, , Greece

Site Status

Hygeia Hospital /ID# 263455

Athens, , Greece

Site Status

KAT Attica General Hospital /ID# 266249

Kifissia, , Greece

Site Status

University General Hospital of Larissa /ID# 263440

Larissa, , Greece

Site Status

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

Thessaloniki, , Greece

Site Status

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

Thessaloniki, , Greece

Site Status

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

Thessaloniki, , Greece

Site Status

Papageorgiou General Hospital /ID# 262529

Thessaloniki, , Greece

Site Status

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

Tripoli, , Greece

Site Status

General Hospital of Xanthi /ID# 268133

Xánthi, , Greece

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Greece

Related Links

Access external resources that provide additional context or updates about the study.

https://www.abbvieclinicaltrials.com/study/?id=P24-179

Related Info

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

P24-179

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Study to Evaluate Adverse Events and Change in Disease Activity in Participants Between 6 and 17 Years With Moderate to Severe Plaque Psoriasis Treated With Subcutaneous (SC) Injection of Risankizumab Who Have Completed Participation in Study M19-977
NCT04862286 ACTIVE_NOT_RECRUITING PHASE3
A Study to Assess Safety and Efficacy of Risankizumab Using a New Formulation in Participants With Moderate to Severe Plaque Psoriasis
NCT03875482 COMPLETED PHASE3
High Dose Risankizumab for Psoriasis
NCT05283135 COMPLETED PHASE2
A Study of the Safety and Efficacy of Risankizumab in Adult Participants With Plaque Psoriasis Who Have Had a Suboptimal Response to Secukinumab or Ixekizumab
NCT04102007 COMPLETED PHASE3
Study to Assess Change in Disease Symptoms in Adult Participants With Moderate to Severe Psoriasis Treated With Subcutaneous Risankizumab Injection According to Standard of Care
NCT04780516 ACTIVE_NOT_RECRUITING
Study to Assess the Change in Disease State When Subcutaneous Risankizumab Injection is Given to Adult Participants With Psoriasis in Taiwan
NCT04818385 COMPLETED
Study of Subcutaneous Risankizumab Injection Compared to Oral Apremilast Tablets to Assess Change in Disease Activity And Adverse Events in Adult Participants With Moderate Plaque Psoriasis Who Are Candidates for Systemic Therapy
NCT04908475 COMPLETED PHASE4
Extension Trial Assessing the Safety and Efficacy of BI 655066/ABBV-066/Risankizumab in Patients With Moderate to Severe Chronic Plaque Psoriasis
NCT02203851 COMPLETED PHASE2
A Study to Assess the Safety and Efficacy of Risankizumab for Maintenance in Moderate to Severe Plaque Type Psoriasis ( LIMMITLESS )
NCT03047395 COMPLETED PHASE3
A Study Comparing the Safety and Efficacy of Risankizumab to Methotrexate in Subjects With Moderate to Severe Plaque Psoriasis
NCT03219437 COMPLETED PHASE3
Observational Study of Patients With Moderate to Severe Chronic Plaque Psoriasis
NCT03982394 COMPLETED
BI 655066/ABBV-066/Risankizumab Compared to Placebo in Patients With Active Psoriatic Arthritis
NCT02719171 COMPLETED PHASE2
A Study of Subcutaneous Risankizumab Injection for Pediatric Participants With Moderate to Severe Plaque Psoriasis to Assess Change in Disease Symptoms
NCT04435600 COMPLETED PHASE3
Exploring the Effects of IL-23 Inhibition by Risankizumab on Psoriasis Autoimmunity
NCT04722640 UNKNOWN PHASE4
Therapeutic Drug Monitoring of Risankizumab in Psoriasis Patients (BIOLOPTIM-RIS)
NCT05685940 RECRUITING PHASE4
BI 655066 (Risankizumab) Compared to Placebo and Active Comparator (Ustekinumab) in Patients With Moderate to Severe Chronic Plaque Psoriasis
NCT02684370 COMPLETED PHASE3
Risankizumab Long-term Remission Study
NCT04630652 ACTIVE_NOT_RECRUITING PHASE4
A Randomized Double Blind Vehicle Controlled Dose Ranging Parallel Design Multiple Site Clinical Study
NCT02413229 COMPLETED PHASE2
Study to Assess the Safety and Efficacy of Subcutaneously Injected Risankizumab in Adult Participants With Genital or Scalp Psoriasis
NCT05969223 COMPLETED PHASE4
Study to Assess Adverse Events When Subcutaneous Risankizumab Injection is Given to Adult Participants With Psoriasis in Real World Setting
NCT04799990 WITHDRAWN
A Study to Evaluate Raptiva in Adults With Moderate to Severe Plaque Psoriasis Who Are Candidates for Systemic Therapy
NCT00109317 COMPLETED PHASE3
A Multicentre, Open Label Phase IIIb/IV Study of Subcutaneously Administered Raptiva in the Treatment of Adult Subjects With Moderate to Severe Plaque Psoriasis
NCT00287118 COMPLETED PHASE4
A Study to Assess Efficacy and Safety of Two Different Dose Regimens of Risankizumab Administered Subcutaneously in Japanese Subjects With Generalized Pustular Psoriasis or Erythrodermic Psoriasis
NCT03022045 COMPLETED PHASE3
A Study to Assess Usability of Risankizumab Autoinjector Combination Product in Participants With Moderate to Severe Plaque Psoriasis
NCT03875508 COMPLETED PHASE3
BI 655066/ABBV-066 (Risankizumab) Compared to Active Comparator (Adalimumab) in Patients With Moderate to Severe Chronic Plaque Psoriasis
NCT02694523 COMPLETED PHASE3