Status:
COMPLETED
A Study of the Safety and Efficacy of Risankizumab in Adult Participants With Plaque Psoriasis Who Have Had a Suboptimal Response to Secukinumab or Ixekizumab
Lead Sponsor:
AbbVie
Conditions:
Plaque Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 suboptima...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- History of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis, psoriatic arthritis.
- 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.
Key Trial Info
Start Date :
November 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 7 2022
Estimated Enrollment :
244 Patients enrolled
Trial Details
Trial ID
NCT04102007
Start Date
November 12 2019
End Date
November 7 2022
Last Update
November 27 2023
Active Locations (57)
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1
Alliance Dermatology and MOHs /ID# 216001
Phoenix, Arizona, United States, 85032
2
Burke Pharmaceutical Research /ID# 225023
Hot Springs, Arkansas, United States, 71913-6404
3
Arkansas Research Trials /ID# 225497
North Little Rock, Arkansas, United States, 72117
4
Bakersfield Derma & Skin Cance /ID# 213480
Bakersfield, California, United States, 93309