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
NCT ID: NCT04102007
Last Updated: 2023-11-27
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
244 participants
INTERVENTIONAL
2019-11-12
2022-11-07
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Risankizumab
Participants receive Risankizumab following suboptimal response to secukinumab or ixekizumab
Risankizumab
Risankizumab is administered as a subcutaneous (SC) injection in pre-filled syringe (PFS).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Risankizumab
Risankizumab is administered as a subcutaneous (SC) injection in pre-filled syringe (PFS).
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AbbVie
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
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
Universitaetsklinikum Frankfurt /ID# 215889
Frankfurt am Main, Hesse, Germany
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 215691
Berlin, , Germany
Klinikum Ruhr Univ Bochum /ID# 225473
Bochum, , Germany
Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 214469
Lübeck, , Germany
Dermatologische Gemeinschaftspraxis Mahlow /ID# 225472
Mahlow, , Germany
Beldio Research GmbH /ID# 225471
Memmingen, , Germany
Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 214506
Munich, , Germany
The Chaim Sheba Medical Center /ID# 213815
Ramat Gan, Tel Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 213812
Tel Aviv, Tel Aviv, Israel
HaEmek Medical Center /ID# 214059
Afula, , Israel
Rabin Medical Center /ID# 213813
Petah Tikva, , Israel
Istituto Clinico Humanitas /ID# 214749
Rozzano, Milano, Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 214745
Bologna, , Italy
Azienda Ospedaliero Universitaria di Cagliari- Presidio Ospedaliero /ID# 214748
Cagliari, , Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 214750
Milan, , Italy
Azienda Ospedaliero-Universitaria di Modena /ID# 214751
Modena, , Italy
AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 214752
Napoli, , Italy
Hospital Universitario Germans Trias i Pujol /ID# 214031
Badalona, Barcelona, Spain
Hospital Universitario Fundacion Alcorcon /ID# 214033
Alcorcón, Madrid, Spain
Hospital Parc de Salut del Mar /ID# 214034
Barcelona, , Spain
Hospital Puerta del Mar /ID# 214428
Cadiz, , Spain
Hospital Universitario La Paz /ID# 214341
Madrid, , Spain
Hospital Universitario y Politecnico La Fe /ID# 214032
Valencia, , Spain
Chung Shan Medical University Hospital /ID# 213634
Taichung, , Taiwan
National Taiwan University Hospital /ID# 213630
Taipei, , Taiwan
MacKay Memorial Hospital /ID# 213845
Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital /ID# 213631
Taoyuan, , Taiwan
Victoria Hospital /ID# 213881
Kirkcaldy, Fife, United Kingdom
Russells Hall Hospital, Dudley /ID# 213878
Dudley, , 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
Northern Care Alliance NHS Group /ID# 213873
Salford, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Warren RB, Pavlovsky L, Costanzo A, Bukhalo M, Korman NJ, Huang YH, Kokolakis G, Pinter A, Ibrahim N, Zheng Y, Drogaris L, Stakias V, Soliman AM, Rubant S, Thaci D. Efficacy and Safety of Risankizumab in Patients with Psoriasis Showing Suboptimal Response to Secukinumab or Ixekizumab: Results from a Phase 3b, Open-Label, Single-Arm (aIMM) Study. Dermatol Ther (Heidelb). 2024 Dec;14(12):3273-3290. doi: 10.1007/s13555-024-01292-z. Epub 2024 Nov 8.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
Related info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2019-000904-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M19-164
Identifier Type: -
Identifier Source: org_study_id