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

Study Identifier
P20-439
CT.gov Identifier
NCT04780516
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Recruitment Complete
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Study Details

Medical Condition
  • Dermatology - Psoriasis (PsO)
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    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.

    Protocol 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).

    Study Locations

    Location
    Status
    Location
    Duplicate_Kaplan Medical Center /ID# 226569
    Rehovot, Central District, Israel, 7661041
    Status
    Not applicable
    Location
    Leumit /ID# 252029
    Rehovot, Central District, Israel, 9458414
    Status
    Not applicable
    Location
    HaEmek Medical Center /ID# 251040
    Afula, Haifa District, Israel, 1834111
    Status
    Not applicable
    Location
    Shaare Zedek Medical Center /ID# 247319
    Jerusalem, Jerusalem, Israel, 91031
    Status
    Not applicable
    Location
    ZIV Medical Center /ID# 226565
    Safed, Northern District, Israel, 13100
    Status
    Not applicable
    Location
    Barzilai Medical Center /ID# 229156
    Ashkelon, Southern District, Israel, 7830604
    Status
    Not applicable
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