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

This study will evaluate whether adult participants with moderate to severe plaque psoriasis who have been treated with secukinumab or ixekizumab for at least 6 months and are experiencing a suboptimal response may benefit from switching to risankizumab with regard to skin symptoms, quality of life symptoms and psoriasis symptoms. Study duration will last for up to 64 weeks with risankizumab given by subcutaneous injection at Week 0, Week 4, and then every 12 weeks for 52 Weeks. An additional visit will occur at Week 8 for a physical exam and questionnaire collection. A final follow-up phone call will occur at Week 60.

Official Title

A Phase 3b, Multicenter, Interventional, Open-label Study of Adult Subjects With Moderate to Severe Plaque Psoriasis Who Have a Suboptimal Response to Secukinumab or Ixekizumab and Are Switched to Risankizumab

Keywords

Plaque Psoriasis Risankizumab Secukinumab Ixekizumab Psoriasis Biologic Skyrizi

Eligibility

You can join if…

Open to people ages 18 years and up

  • Diagnosed with moderate to severe chronic plaque psoriasis for at least 6 months before Baseline (Week 0).
  • Participant must have been on labeled secukinumab or ixekizumab treatment for at least 6 months and are experiencing suboptimal response at time of Screening and Baseline visits.
  • Participant must have a Body Surface Area (BSA) 3%- <10% and Static Physician Global Assessment (sPGA) 2/3
  • Participant must be eligible for continued biologic therapy as assessed by the investigator.

You CAN'T join if...

  • History of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis.
  • Participant with active skin disease other than plaque psoriasis that could interfere with the assessment of plaque psoriasis.
  • History of any documented active or suspected malignancy or history of any malignancy within the last 5 years except for successfully treated non-melanoma skin cancer (NMSC) or localized carcinoma in situ of the cervix.
  • History of major surgery within 12 weeks prior to Baseline or planned to be performed during the conduct of the trial as assessed by the investigator.
  • Participant with exposure to risankizumab or any IL-23 inhibitors.
  • No known active SARS-CoV-2 infection. -- At least 14 days since first PCR test result have passed in asymptomatic participants or 14 days since recovery, defined as resolution of fever without use of antipyretics and improvement in symptoms.

Locations

  • UC Davis Health /ID# 225367
    Sacramento California 95816-3300 United States
  • Bakersfield Derma & Skin Cance /ID# 213480
    Bakersfield California 93309 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
Links
Sign up for this study
ID
NCT04102007
Phase
Phase 3
Study Type
Interventional
Last Updated