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 (With the last dose being administered at Week 40). 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
244
Risankizumab is administered as a subcutaneous (SC) injection in pre-filled syringe (PFS).
Alliance Dermatology and MOHs /ID# 216001
Phoenix, Arizona, United States
Burke Pharmaceutical Research /ID# 225023
Hot Springs, Arkansas, United States
Arkansas Research Trials /ID# 225497
North Little Rock, Arkansas, United States
Bakersfield Derma & Skin Cance /ID# 213480
Bakersfield, California, United States
UC Davis Health /ID# 225367
Sacramento, California, United States
Proportion of Participants Achieving Static Physician Global Assessment (sPGA) 0/1
The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.
Time frame: At Week 16
Proportion of Participants Achieving a sPGA Clear Response (sPGA 0)
The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.
Time frame: At Week 16
Proportion of Participants Achieving a Dermatology Life Quality Index (DLQI) 0/1
The DLQI is a self-administered, 10-question questionnaire covering 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and bother with psoriasis treatment). The response options range from 0, not affected at all, to 3, very much affected. This gives an overall range of 0 to 30 where lower scores mean better quality of life.
Time frame: At Week 16
Proportion of Participants Achieving a Psoriasis Symptoms Scale (PSS) 0
The PSS is a 4-item patient-reported outcome (PRO) instrument that assesses the severity of psoriasis symptoms in patients with moderate to severe psoriasis (Appendix 8.2). The symptoms included are: pain, redness, itching and burning from psoriasis. Current symptom severity is assessed as a daily diary, using a 5-point scale ranging from 0 (none) to 4 (very severe).
Time frame: At Week 16
Proportion of Participants Achieving Static Physician Global Assessment (sPGA) 0/1
The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.
Time frame: At Week 52
Proportion of Participants Achieving a sPGA Clear Response (sPGA 0)
The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.
Time frame: At Week 52
Proportion of Participants Achieving a Dermatology Life Quality Index (DLQI) 0/1
The DLQI is a self-administered, 10-question questionnaire covering 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and bother with psoriasis treatment). The response options range from 0, not affected at all, to 3, very much affected. This gives an overall range of 0 to 30 where lower scores mean better quality of life.
Time frame: At Week 52
Proportion of Participants Achieving a PSS 0
The PSS is a 4-item patient-reported outcome (PRO) instrument that assesses the severity of psoriasis symptoms in patients with moderate to severe psoriasis (Appendix 8.2). The symptoms included are: pain, redness, itching and burning from psoriasis. Current symptom severity is assessed as a daily diary, using a 5-point scale ranging from 0 (none) to 4 (very severe).
Time frame: At Week 52
Time to Achieve sPGA 0/1
The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.
Time frame: Up to Week 52
Time to Achieve sPGA 0
The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.
Time frame: Up to Week 52
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CCD Research, PLLC /ID# 216062
Cromwell, Connecticut, United States
Florida International Rsrch cr /ID# 224983
Miami, Florida, United States
Advanced Medical Research /ID# 213484
Sandy Springs, Georgia, United States
Arlington Dermatology /ID# 216000
Rolling Meadows, Illinois, United States
Dawes Fretzin, LLC /ID# 216004
Indianapolis, Indiana, United States
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