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

  • STATUS
    Recruiting
  • End date
    Apr 2, 2023
  • participants needed
    330
  • sponsor
    AbbVie
Updated on 19 September 2021
Investigator
AbbVie_Call Center
Primary Contact
Eastern Canada Cutaneous Resea /ID# 230120 (0.9 mi away) Contact
+66 other location
systemic therapy
arthritis
risankizumab
apremilast
plaque psoriasis

Summary

Psoriasis (PsO) is a chronic disease characterized by marked inflammation of the skin that results in thick, red, scaly plaques. This study will assess how safe and effective risankizumab is compared to apremilast in adult participants with moderate plaque psoriasis. Adverse events and change in disease symptoms will be monitored.

Risankizumab (Skyrizi) and apremilast are approved drugs for the treatment of moderate to severe PsO. Approximately 330 participants with moderate plaque psoriasis (PsO) will be enrolled across approximately 55 sites globally.

The study has 2 periods : Period A from Baseline to Week 16, and Period B, from Week 16 to Week 52. In Period A, participants will be randomly placed into 2 groups to receive either subcutaneous risankizumab or oral apremilast for 16 weeks. In Period B, participants who received apremilast in Period A will again be randomly assigned to 1 of the 2 groups to receive either risankizumab or apremilast for 36 weeks. At weeks 28 and 40, participants considered non-responders to apremilast based on their psoriasis score will be offered to receive risankizumab.

There may be a higher burden for participants in this study compared to usual standard of care. Participants will attend regular visits per routine clinical practice. The effect of the treatment will be checked by medical assessments, checking for side effects, and questionnaires.

Details
Condition Psoriasis
Treatment Apremilast, risankizumab
Clinical Study IdentifierNCT04908475
SponsorAbbVie
Last Modified on19 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Candidates for systemic therapy with moderate chronic plaque psoriasis (PsO) (with or without psoriatic arthritis) at Screening and Baseline for at least 6 months prior to Baseline defined as
Body Surface Area (BSA) >= 10% and <= 15%; and
Psoriasis Area and Severity Index (PASI) >= 12; and
Static Physician Global Assessment (sPGA) = 3 (moderate) based on a 5-point scale (0 to 4)

Exclusion Criteria

Participant has any form of PsO other than chronic plaque PsO (e.g., pustular PsO, palmoplantar pustulosis, acrodermatitis of Hallopeau, erythrodermic, or guttate PsO)
History of current drug-induced PsO or a drug-induced exacerbation of pre-existing psoriasis
History of active ongoing inflammatory skin diseases other than PsO and psoriatic arthritis that could interfere with the assessment of PsO (e.g., hyperkeratotic eczema)
Prior exposure to risankizumab or apremilast
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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