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 (prIMMa)

AbbVie

Status: Active, not recruiting

Conditions: Psoriasis

Study type: Observational

Funder types: Industry

Identifiers

NCT04780516

P20-439

Details and patient eligibility

About

Psoriasis is a chronic inflammatory skin condition that is characterized by symptoms such as pain, itching and discomfort. This can have severe impact on the quality of life including depression, embarrassment, and social isolation. The objective of this study is to evaluate how effective risankizumab is in changing the disease symptoms in adult participants with moderate to severe psoriasis.

Risankizumab is an approved drug being developed for the treatment of psoriasis. Adult participants who are prescribed risankizumab treatment according to the local label will be enrolled in this study. Approximately 125 adult participants with moderate to severe psoriasis will be enrolled at multiple sites across Israel.

Participants who are prescribed to receive subcutaneous risankizumab injection by their physician according to local label will be enrolled and will be followed for approximately 2 years.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects, patient charts, questionnaires, and remote monitoring device (patch sensor).

Enrollment: 141 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of moderate to severe psoriasis.
• Prescribed risankizumab as the standard treatment for psoriasis, according to the local label. The decision to prescribe risankizumab will be made solely by the physician, based on his clinical judgment, and is done prior to any decision to approach the participant to participate in this study.
• Willing to be involved in the study, to sign an informed consent form and complete study questionnaires.
• Participants participating in digital component: Pruritus Numeric Rating Scale (PNRS) score >=4 at baseline.

Exclusion criteria

• Participants participating in a concurrent clinical interventional study or within 30 days.
• Participants treated with risankizumab prior to baseline visit.

Trial design

141 participants in 1 patient group

Participants Treated With Risankizumab

Description:

Participants will receive risankizumab (Skyrizi) as prescribed by the physician according to the local label.