Summary

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

Description

Summary

The objectives of this study are to evaluate the usability of the combination product of risankizumab in an autoinjector (AI), as well as to evaluate the efficacy, safety, and tolerability of risankizumab administered by AI for the treatment of participants with moderate to severe plaque psoriasis.

Official Title

A Multicenter, Single-Arm, Open Label, Assessor-Blinded Study to Assess the Usability of the Risankizumab Autoinjector Combination Product in Adult Patients With Moderate to Severe Plaque Psoriasis

Keywords

Psoriasis Risankizumab Plaque Psoriasis Antibodies, Monoclonal Autoinjector Risankizumab autoinjector

Eligibility

You can join if…

Open to people ages 18 years and up

  • Participant has diagnosis of chronic plaque psoriasis for at least 6 months before the baseline visit.
  • Participant meets following disease activity criteria:
  • Stable moderate to severe chronic plaque psoriasis, defined as greater than or equal to 10% body surface area (BSA) psoriasis involvement, static physician global assessment (sPGA) score of greater than or equal to 3, and Psoriasis Area Severity Index (PASI) greater than or equal to 12 at Screening and baseline visit.
  • Candidate for systemic therapy as assessed by the investigator.

You CAN'T join if...

  • Participant has history of active skin disease other than psoriasis that could interfere with the assessment of psoriasis.
  • Participant has history of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis.
  • Participant has previous exposure to risankizumab.

Locations

  • University of California Irvine /ID# 210776
    Irvine California 92697-1385 United States
  • Tien Q Nguyen MD, Inc /ID# 210775
    Fountain Valley California 92708-3701 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
ID
NCT03875508
Phase
Phase 3
Study Type
Interventional
Last Updated