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

Phase 3

Completed

Conditions: Plaque Psoriasis

Interventions: Drug: Risankizumab

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

Inclusion Criteria

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 Criteria

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): Northern Care Alliance NHS Group /ID# 213873
🇬🇧
Salford, United Kingdom
Burke Pharmaceutical Research /ID# 225023
🇺🇸
Hot Springs, Arkansas, United States
Arkansas Research Trials /ID# 225497
🇺🇸
North Little Rock, Arkansas, United States
CCD Research, PLLC /ID# 216062
🇺🇸
Cromwell, Connecticut, United States
Linkou Chang Gung Memorial Hospital /ID# 213631
🇨🇳
Taoyuan City, Taiwan
Alliance Dermatology and MOHs /ID# 216001
🇺🇸
Phoenix, Arizona, United States
Istituto Clinico Humanitas /ID# 214749
🇮🇹
Rozzano, Milano, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 214750
🇮🇹
Milan, Italy
AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 214752
🇮🇹
Napoli, Italy
Skin Health Institute Inc /ID# 213886
🇦🇺
Carlton, Victoria, Australia
Dawes Fretzin, LLC /ID# 216004
🇺🇸
Indianapolis, Indiana, United States
DermAssociates-Rockville /ID# 213837
🇺🇸
Rockville, Maryland, United States
Menter Dermatology Res Inst /ID# 214002
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Dallas, Texas, United States
Advanced Medical Research /ID# 213484
🇺🇸
Sandy Springs, Georgia, United States
The Chaim Sheba Medical Center /ID# 213815
🇮🇱
Ramat Gan, Tel-Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 213812
🇮🇱
Tel Aviv-Yafo, Tel-Aviv, Israel
Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 214469
🇩🇪
Luebeck, Germany
Central Dermatology, PC /ID# 213479
🇺🇸
Saint Louis, Missouri, United States
Dermatologische Gemeinschaftspraxis Mahlow /ID# 225472
🇩🇪
Mahlow, Germany
Clinical Partners, LLC /ID# 213836
🇺🇸
Johnston, Rhode Island, United States
Arlington Research Center, Inc /ID# 215526
🇺🇸
Arlington, Texas, United States
University Hospitals Case Medical Center /ID# 214795
🇺🇸
Cleveland, Ohio, United States
Universitaetsklinikum Erlangen /ID# 214228
🇩🇪
Erlangen, Bayern, Germany
University of Pittsburgh MC /ID# 225644
🇺🇸
Pittsburgh, Pennsylvania, United States
Cleaver Dermatology /ID# 226137
🇺🇸
Kirksville, Missouri, United States
Azienda Ospedaliero Universitaria di Cagliari- Presidio Ospedaliero /ID# 214748
🇮🇹
Cagliari, Italy
Hospital Universitario Fundacion Alcorcon /ID# 214033
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Alcorcon, Madrid, Spain
Hospital Universitario Germans Trias i Pujol /ID# 214031
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Badalona, Barcelona, Spain
HaEmek Medical Center /ID# 214059
🇮🇱
Afula, Israel
Azienda Ospedaliero-Universitaria di Modena /ID# 214751
🇮🇹
Modena, Italy
Hospital Parc de Salut del Mar /ID# 214034
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Barcelona, Spain
Fremantle Dermatology /ID# 213887
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Fremantle, Western Australia, Australia
Chung Shan Medical University Hospital /ID# 213634
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Taichung, Taiwan
MacKay Memorial Hospital /ID# 213845
🇨🇳
Taipei City, Taiwan
National Taiwan University Hospital /ID# 213630
🇨🇳
Taipei City, Taiwan
Beldio Research GmbH /ID# 225471
🇩🇪
Memmingen, Germany
Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 214506
🇩🇪
Munich, Germany
Universitaetsklinikum Frankfurt /ID# 215889
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Frankfurt am Main, Hessen, Germany
Veracity Clinical Research /ID# 213889
🇦🇺
Woolloongabba, Queensland, Australia
Bellaire Dermatology /ID# 225486
🇺🇸
Bellaire, Texas, United States
Modern Research Associates, PL /ID# 213835
🇺🇸
Dallas, Texas, United States
St George Dermatology & Skin Cancer Centre /ID# 213888
🇦🇺
Kogarah, New South Wales, Australia
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 215691
🇩🇪
Berlin, Germany
Klinikum Ruhr Univ Bochum /ID# 225473
🇩🇪
Bochum, Germany
Florida International Rsrch cr /ID# 224983
🇺🇸
Miami, Florida, United States
Bakersfield Derma & Skin Cance /ID# 213480
🇺🇸
Bakersfield, California, United States
UC Davis Health /ID# 225367
🇺🇸
Sacramento, California, United States
Arlington Dermatology /ID# 216000
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Rolling Meadows, Illinois, United States
Rabin Medical Center /ID# 213813
🇮🇱
Petakh Tikva, Israel
IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 214745
🇮🇹
Bologna, Italy
Hospital Puerta del Mar /ID# 214428
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Cadiz, Spain
Hospital Universitario La Paz /ID# 214341
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Madrid, Spain
Hospital Universitario y Politecnico La Fe /ID# 214032
🇪🇸
Valencia, Spain
Russells Hall Hospital, Dudley /ID# 213878
🇬🇧
Dudley, United Kingdom
Victoria Hospital /ID# 213881
🇬🇧
Kirkcaldy, Fife, United Kingdom
Leeds Teaching Hospitals NHS Trust /ID# 213880
🇬🇧
Leeds, United Kingdom
The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 213877
🇬🇧
Newcastle Upon Tyne, United Kingdom