Clinical trial NCT06247319: Study to Evaluate the Effectiveness of Risankizumab in Participants With a Recent Diagnosis of Moderate Plaque Psoriasis in a Real-life Setting in Greece
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Moderate Plaque Psoriasis
Moderate Psoriasis
Psoriasis
Keywords: Moderate Psoriasis
Psoriasis
Moderate Plaque Psoriasis
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2024-02-07
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of participants achieving Psoriasis Area and Severity Index (PASI) score less than or equal to 2
timeFrame: Baseline to Week 16
measure: 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)
timeFrame: Baseline to Week 16
Secondary outcomes:
Other outcomes:
Locations:
city: Patras
country: Greece
facility: Olympion General Clinic /ID# 266258
state: Achaia
city: Athens
country: Greece
facility: Iatriko Psichikou /ID# 272851
state: Attiki
city: Athens
country: Greece
facility: 251 Hellenic Air Force General Hospital /ID# 268135
state: Attiki
city: Athens
country: Greece
facility: University General Hospital Attikon /ID# 263442
state: Attiki
city: Athens
country: Greece
facility: General Hospital Andreas Syggros /ID# 263443
state: Attiki
city: Athens
country: Greece
facility: General Hospital Andreas Syggros /ID# 266248
state: Attiki
city: Pireas
country: Greece
facility: Tzaneio Prefecture General Hospital of Piraeus /ID# 263448
state: Attiki
city: Voula
country: Greece
facility: Asklipieio General Hospital of Voula /ID# 268136
state: Attiki
city: Iraklio
country: Greece
facility: Venizelio Regional General Hospital of Heraklion /ID# 268778
state: Irakleio
city: Nea Ionia
country: Greece
facility: Konstantopoulio General Hospital /ID# 266257
state: Magnisia
city: Agia Varvara
country: Greece
facility: West Attica General Hospital "Agia Varvara" /ID# 266256
city: Athens
country: Greece
facility: 401 General Military Hospital /ID# 277393
city: Athens
country: Greece
facility: Hygeia Hospital /ID# 263455
city: Heraklion
country: Greece
facility: University General Hospital of Heraklion /ID# 268777
city: Kifissia
country: Greece
facility: KAT Attica General Hospital /ID# 266249
city: Larissa
country: Greece
facility: University General Hospital of Larissa /ID# 263440
city: Thessaloniki
country: Greece
facility: Hospital of Skin and Venereal Diseases- Thessaloniki /ID# 262530
city: Thessaloniki
country: Greece
facility: Hospital of Skin and Venereal Diseases- Thessaloniki /ID# 263452
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki "Agios Pavlos'' /ID# 267506
city: Thessaloniki
country: Greece
facility: Papageorgiou General Hospital /ID# 262529
city: Tripoli
country: Greece
facility: General Hospital of Tripoli Panarkadiko "Evangelistria" /ID# 266251
city: Xanthi
country: Greece
facility: General Hospital of Xanthi /ID# 268133
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: