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

Completed · Phase 3

Conditions studied: Plaque Psoriasis

In brief

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.

Key facts

Study ID

NCT04102007

Run by

AbbVie

People needed

244

Starts

2019-11-12

Expected to finish

2022-11-07

Last updated by the study team

2023-11-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify if…

• 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.

Where it is running

• 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
• DermAssociates-Rockville /ID# 213837 — Rockville, Maryland, United States
• Cleaver Dermatology /ID# 226137 — Kirksville, Missouri, United States
• Central Dermatology, PC /ID# 213479 — St Louis, Missouri, United States
• University Hospitals Case Medical Center /ID# 214795 — Cleveland, Ohio, United States
• University of Pittsburgh MC /ID# 225644 — Pittsburgh, Pennsylvania, United States
• Clinical Partners, LLC /ID# 213836 — Johnston, Rhode Island, United States
• Arlington Research Center, Inc /ID# 215526 — Arlington, Texas, United States
• Bellaire Dermatology /ID# 225486 — Bellaire, Texas, United States
• Modern Research Associates, PL /ID# 213835 — Dallas, Texas, United States
• Menter Dermatology Res Inst /ID# 214002 — Dallas, Texas, United States
• St George Dermatology & Skin Cancer Centre /ID# 213888 — Kogarah, New South Wales, Australia
• Veracity Clinical Research /ID# 213889 — Woolloongabba, Queensland, Australia
• Skin Health Institute Inc /ID# 213886 — Carlton, Victoria, Australia
• Fremantle Dermatology /ID# 213887 — Fremantle, Western Australia, Australia
• Universitaetsklinikum Erlangen /ID# 214228 — Erlangen, Bavaria, Germany
• Alliance Dermatology and MOHs /ID# 216001 — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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