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Active Not RecruitingNCT04780516

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

Prospective Non-Interventional Study to Investigate the Durable Effectiveness of Risankizumab Using Digital and Remote Evaluation Tools in Moderate to Severe Psoriasis Patients - prIMMa Study

Status
Active Not Recruiting
Phase
Study type
Observational
Enrollment
141 (actual)
Sponsor
AbbVie · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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).

Conditions

Timeline

Start date
2021-04-26
Primary completion
2024-01-02
Completion
2026-12-01
First posted
2021-03-03
Last updated
2025-08-13

Locations

11 sites across 1 country: Israel

Source: ClinicalTrials.gov record NCT04780516. Inclusion in this directory is not an endorsement.