Status:
COMPLETED
Study of Subcutaneous (Injected Under the Skin) Risankizumab to Assess Change in Disease Symptoms in Adult Participants With Moderate to Severe Plaque Psoriasis With Palmoplantar Involvement
Lead Sponsor:
AbbVie
Conditions:
Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Plaque Psoriasis is a chronic inflammatory disease in which skin cells build up and develop scaly red and white patches on the skin. It is caused by an overactive immune system where the body attacks ...
Eligibility Criteria
Inclusion
- Diagnosis of chronic palmoplantar plaque psoriasis (PPPsO) (with or without psoriatic arthritis) for at least 6 months before Baseline and a Palmoplantar Investigator's Global Assessment (ppIGA) of moderate or severe, at Screening and Baseline.
- Must have at Screening and Baseline a plaque psoriasis (PsO) body surface area (BSA) involvement of greater than or equal to one percent, an Static Physician's Global Assessment (sPGA) score of moderate to severe (greater than or equal to three), a PPASI moderate to severe (greater than or equal to eight), at least one additional PsO plaque outside of the palms and soles.
- Must be a candidate for systemic therapy as assessed by the investigator.
- Previously had inadequately controlled disease by topicals, phototherapy and/or systemic treatments.
Exclusion
- History of PsO other than chronic plaque type PsO
- History of current drug-induced PsO or a drug-induced exacerbation of pre-existing psoriasis.
- Ongoing inflammatory skin diseases other than PsO and psoriatic arthritis that could interfere with PsO assessments.
- Evidence of Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, human immunodeficiency virus (HIV), Active tuberculosis, Active systemic infection/clinically important infections in the last two weeks prior to Baseline.
- Prior exposure to risankizumab.
Key Trial Info
Start Date :
February 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 20 2023
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT04713592
Start Date
February 26 2021
End Date
April 20 2023
Last Update
June 14 2024
Active Locations (55)
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1
Advanced Research Associates - Glendale /ID# 219197
Glendale, Arizona, United States, 85308
2
Burke Pharmaceutical Research /ID# 223349
Hot Springs, Arkansas, United States, 71913-6404
3
NW Arkansas Clinical Trials Center /ID# 231602
Rogers, Arkansas, United States, 72758
4
Dermatology Research Associates /ID# 219195
Los Angeles, California, United States, 90045