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
- Registration Number
- NCT04102007
- Lead Sponsor
- AbbVie
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 244
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Risankizumab Risankizumab Participants receive Risankizumab following suboptimal response to secukinumab or ixekizumab
- Primary Outcome Measures
Name Time Method Proportion of Participants Achieving Static Physician Global Assessment (sPGA) 0/1 At Week 16 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.
- Secondary Outcome Measures
Name Time Method Proportion of Participants Achieving a Dermatology Life Quality Index (DLQI) 0/1 At Week 52 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.
Proportion of Participants Achieving Static Physician Global Assessment (sPGA) 0/1 At Week 52 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 to Achieve sPGA 0/1 Up to Week 52 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.
Proportion of Participants Achieving a sPGA Clear Response (sPGA 0) At Week 52 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.
Proportion of Participants Achieving a Psoriasis Symptoms Scale (PSS) 0 At Week 16 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).Proportion of Participants Achieving a PSS 0 At Week 52 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 to Achieve sPGA 0 Up to Week 52 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.
Trial Locations
- Locations (57)
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
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
Scroll for more (47 remaining)Alliance Dermatology and MOHs /ID# 216001🇺🇸Phoenix, Arizona, United States