Psoriasis Clinical Trial

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

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.

View Eligibility Criteria

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.

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

244

Study ID:

NCT04102007

Recruitment Status:

Completed

Sponsor:

AbbVie

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There are 57 Locations for this study

See Locations Near You

Alliance Dermatology and MOHs /ID# 216001
Phoenix Arizona, 85032, United States
Burke Pharmaceutical Research /ID# 225023
Hot Springs Arkansas, 71913, United States
Arkansas Research Trials /ID# 225497
North Little Rock Arkansas, 72117, United States
Bakersfield Derma & Skin Cance /ID# 213480
Bakersfield California, 93309, United States
UC Davis Health /ID# 225367
Sacramento California, 95816, United States
CCD Research, PLLC /ID# 216062
Cromwell Connecticut, 06416, United States
Florida International Rsrch cr /ID# 224983
Miami Florida, 33173, United States
Advanced Medical Research /ID# 213484
Sandy Springs Georgia, 30328, United States
Arlington Dermatology /ID# 216000
Rolling Meadows Illinois, 60008, United States
Dawes Fretzin, LLC /ID# 216004
Indianapolis Indiana, 46256, United States
DermAssociates-Rockville /ID# 213837
Rockville Maryland, 20850, United States
Cleaver Dermatology /ID# 226137
Kirksville Missouri, 63501, United States
Central Dermatology, PC /ID# 213479
Saint Louis Missouri, 63117, United States
University Hospitals Case Medical Center /ID# 214795
Cleveland Ohio, 44106, United States
University of Pittsburgh MC /ID# 225644
Pittsburgh Pennsylvania, 15260, United States
Clinical Partners, LLC /ID# 213836
Johnston Rhode Island, 02919, United States
Arlington Research Center, Inc /ID# 215526
Arlington Texas, 76011, United States
Bellaire Dermatology /ID# 225486
Bellaire Texas, 77401, United States
Modern Research Associates, PL /ID# 213835
Dallas Texas, 75231, United States
Menter Dermatology Res Inst /ID# 214002
Dallas Texas, 75246, United States
St George Dermatology & Skin Cancer Centre /ID# 213888
Kogarah New South Wales, 2217, Australia
Veracity Clinical Research /ID# 213889
Woolloongabba Queensland, 4102, Australia
Skin Health Institute Inc /ID# 213886
Carlton Victoria, 3053, Australia
Fremantle Dermatology /ID# 213887
Fremantle Western Australia, 6160, Australia
Universitaetsklinikum Erlangen /ID# 214228
Erlangen Bayern, 91054, Germany
Universitaetsklinikum Frankfurt /ID# 215889
Frankfurt am Main Hessen, 60590, Germany
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 215691
Berlin , 10117, Germany
Klinikum Ruhr Univ Bochum /ID# 225473
Bochum , 44791, Germany
Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 214469
Luebeck , 23538, Germany
Dermatologische Gemeinschaftspraxis Mahlow /ID# 225472
Mahlow , 15831, Germany
Beldio Research GmbH /ID# 225471
Memmingen , 87700, Germany
Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 214506
Munich , 81675, Germany
The Chaim Sheba Medical Center /ID# 213815
Ramat Gan Tel-Aviv, 52656, Israel
Tel Aviv Sourasky Medical Center /ID# 213812
Tel Aviv-Yafo Tel-Aviv, 64239, Israel
HaEmek Medical Center /ID# 214059
Afula , 18341, Israel
Rabin Medical Center /ID# 213813
Petakh Tikva , 49414, Israel
Istituto Clinico Humanitas /ID# 214749
Rozzano Milano, 20089, Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 214745
Bologna , 40138, Italy
Azienda Ospedaliero Universitaria di Cagliari- Presidio Ospedaliero /ID# 214748
Cagliari , 09124, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 214750
Milan , 20122, Italy
Azienda Ospedaliero-Universitaria di Modena /ID# 214751
Modena , 41124, Italy
AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 214752
Napoli , 80138, Italy
Hospital Universitario Germans Trias i Pujol /ID# 214031
Badalona Barcelona, 08916, Spain
Hospital Universitario Fundacion Alcorcon /ID# 214033
Alcorcon Madrid, 28922, Spain
Hospital Parc de Salut del Mar /ID# 214034
Barcelona , 08003, Spain
Hospital Puerta del Mar /ID# 214428
Cadiz , 11009, Spain
Hospital Universitario La Paz /ID# 214341
Madrid , 28046, Spain
Hospital Universitario y Politecnico La Fe /ID# 214032
Valencia , 46026, Spain
Chung Shan Medical University Hospital /ID# 213634
Taichung , 40201, Taiwan
National Taiwan University Hospital /ID# 213630
Taipei City , 100, Taiwan
MacKay Memorial Hospital /ID# 213845
Taipei City , 10449, Taiwan
Linkou Chang Gung Memorial Hospital /ID# 213631
Taoyuan City , 333, Taiwan
Victoria Hospital /ID# 213881
Kirkcaldy Fife, KY2 5, United Kingdom
Russells Hall Hospital, Dudley /ID# 213878
Dudley , DY1 2, United Kingdom
Leeds Teaching Hospitals NHS Trust /ID# 213880
Leeds , LS9 7, United Kingdom
The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 213877
Newcastle Upon Tyne , NE7 7, United Kingdom
Northern Care Alliance NHS Group /ID# 213873
Salford , M6 8H, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

244

Study ID:

NCT04102007

Recruitment Status:

Completed

Sponsor:


AbbVie

How clear is this clinincal trial information?

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