Clinical trial NCT04102007: 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
Official title: A Phase 3b, Multicenter, Interventional, Open-label Study of Adult Subjects With Moderate to Severe Plaque Psoriasis Who Have a Suboptimal Response to Secukinumab or Ixekizumab and Are Switched to Risankizumab
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Plaque Psoriasis
Keywords: Plaque Psoriasis Risankizumab Secukinumab Ixekizumab Psoriasis Biologic
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2019-09-25
Enrollment: 244
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of Participants Achieving Static Physician Global Assessment (sPGA) 0/1
timeFrame: At Week 16
Secondary outcomes:
measure: Proportion of Participants Achieving a sPGA Clear Response (sPGA 0)
timeFrame: At Week 16
measure: Proportion of Participants Achieving a Dermatology Life Quality Index (DLQI) 0/1
timeFrame: At Week 16
measure: Proportion of Participants Achieving a Psoriasis Symptoms Scale (PSS) 0
timeFrame: At Week 16
measure: Proportion of Participants Achieving Static Physician Global Assessment (sPGA) 0/1
timeFrame: At Week 52
measure: Proportion of Participants Achieving a sPGA Clear Response (sPGA 0)
timeFrame: At Week 52
measure: Proportion of Participants Achieving a Dermatology Life Quality Index (DLQI) 0/1
timeFrame: At Week 52
measure: Proportion of Participants Achieving a PSS 0
timeFrame: At Week 52
measure: Time to Achieve sPGA 0/1
timeFrame: Up to Week 52
measure: Time to Achieve sPGA 0
timeFrame: Up to Week 52
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Alliance Dermatology and MOHs /ID# 216001
state: Arizona
city: Hot Springs
country: United States
facility: Burke Pharmaceutical Research /ID# 225023
state: Arkansas
city: North Little Rock
country: United States
facility: Arkansas Research Trials /ID# 225497
state: Arkansas
city: Bakersfield
country: United States
facility: Bakersfield Derma & Skin Cance /ID# 213480
state: California
city: Sacramento
country: United States
facility: UC Davis Health /ID# 225367
state: California
city: Cromwell
country: United States
facility: CCD Research, PLLC /ID# 216062
state: Connecticut
city: Miami
country: United States
facility: Florida International Rsrch cr /ID# 224983
state: Florida
city: Sandy Springs
country: United States
facility: Advanced Medical Research /ID# 213484
state: Georgia
city: Rolling Meadows
country: United States
facility: Arlington Dermatology /ID# 216000
state: Illinois
city: Indianapolis
country: United States
facility: Dawes Fretzin, LLC /ID# 216004
state: Indiana
city: Rockville
country: United States
facility: DermAssociates-Rockville /ID# 213837
state: Maryland
city: Kirksville
country: United States
facility: Cleaver Dermatology /ID# 226137
state: Missouri
city: Saint Louis
country: United States
facility: Central Dermatology, PC /ID# 213479
state: Missouri
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center /ID# 214795
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh MC /ID# 225644
state: Pennsylvania
city: Johnston
country: United States
facility: Clinical Partners, LLC /ID# 213836
state: Rhode Island
city: Arlington
country: United States
facility: Arlington Research Center, Inc /ID# 215526
state: Texas
city: Bellaire
country: United States
facility: Bellaire Dermatology /ID# 225486
state: Texas
city: Dallas
country: United States
facility: Modern Research Associates, PL /ID# 213835
state: Texas
city: Dallas
country: United States
facility: Menter Dermatology Res Inst /ID# 214002
state: Texas
city: Kogarah
country: Australia
facility: St George Dermatology & Skin Cancer Centre /ID# 213888
state: New South Wales
city: Woolloongabba
country: Australia
facility: Veracity Clinical Research /ID# 213889
state: Queensland
city: Carlton
country: Australia
facility: Skin Health Institute Inc /ID# 213886
state: Victoria
city: Fremantle
country: Australia
facility: Fremantle Dermatology /ID# 213887
state: Western Australia
city: Erlangen
country: Germany
facility: Universitaetsklinikum Erlangen /ID# 214228
state: Bayern
city: Frankfurt am Main
country: Germany
facility: Universitaetsklinikum Frankfurt /ID# 215889
state: Hessen
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 215691
city: Bochum
country: Germany
facility: Klinikum Ruhr Univ Bochum /ID# 225473
city: Luebeck
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 214469
city: Mahlow
country: Germany
facility: Dermatologische Gemeinschaftspraxis Mahlow /ID# 225472
city: Memmingen
country: Germany
facility: Beldio Research GmbH /ID# 225471
city: Munich
country: Germany
facility: Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 214506
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center /ID# 213815
state: Tel-Aviv
city: Tel Aviv-Yafo
country: Israel
facility: Tel Aviv Sourasky Medical Center /ID# 213812
state: Tel-Aviv
city: Afula
country: Israel
facility: HaEmek Medical Center /ID# 214059
city: Petakh Tikva
country: Israel
facility: Rabin Medical Center /ID# 213813
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas /ID# 214749
state: Milano
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 214745
city: Cagliari
country: Italy
facility: Azienda Ospedaliero Universitaria di Cagliari- Presidio Ospedaliero /ID# 214748
city: Milan
country: Italy
facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 214750
city: Modena
country: Italy
facility: Azienda Ospedaliero-Universitaria di Modena /ID# 214751
city: Napoli
country: Italy
facility: AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 214752
city: Badalona
country: Spain
facility: Hospital Universitario Germans Trias i Pujol /ID# 214031
state: Barcelona
city: Alcorcon
country: Spain
facility: Hospital Universitario Fundacion Alcorcon /ID# 214033
state: Madrid
city: Barcelona
country: Spain
facility: Hospital Parc de Salut del Mar /ID# 214034
city: Cadiz
country: Spain
facility: Hospital Puerta del Mar /ID# 214428
city: Madrid
country: Spain
facility: Hospital Universitario La Paz /ID# 214341
city: Valencia
country: Spain
facility: Hospital Universitario y Politecnico La Fe /ID# 214032
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital /ID# 213634
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital /ID# 213630
city: Taipei City
country: Taiwan
facility: MacKay Memorial Hospital /ID# 213845
city: Taoyuan City
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital /ID# 213631
city: Kirkcaldy
country: United Kingdom
facility: Victoria Hospital /ID# 213881
state: Fife
city: Dudley
country: United Kingdom
facility: Russells Hall Hospital, Dudley /ID# 213878
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust /ID# 213880
city: Newcastle Upon Tyne
country: United Kingdom
facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 213877
city: Salford
country: United Kingdom
facility: Northern Care Alliance NHS Group /ID# 213873
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: