Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
estimated completion

Description

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.

Official Title

A Phase 3b Multicenter, Randomized, Open-label, Efficacy Assessor-blinded Study of Risankizumab Compared to Apremilast for the Treatment of Adult Subjects With Moderate Plaque Psoriasis Who Are Candidates for Systemic Therapy

Keywords

Psoriasis Plaque Psoriasis Risankizumab ABBV-066 Skyrizi Apremilast

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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).

You CAN'T join if...

  • 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.

Locations

  • UC Davis Health /ID# 229133 accepting new patients
    Sacramento California 95816-3300 United States
  • Oregon Dermatology and Research Center /ID# 233462 accepting new patients
    Portland Oregon 97210 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
Links
Related Info Sign up for this study
ID
NCT04908475
Phase
Phase 3
Study Type
Interventional
Last Updated