A Study to Learn How Safe and Effective Risankizumab is When Compared to Deucravacitinib to Treat Participants With Moderate Plaque Psoriasis and Who Need to Try Systemic Treatment (Works Throughout the Whole Body)
NCT ID: NCT06333860
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
393 participants
INTERVENTIONAL
2024-05-10
2026-03-31
Brief Summary
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This study is designed to enroll 336 participants 18 years of age and older with have been diagnosed with moderate chronic plaque psoriasis for at least 6 months prior to Baseline (Day 1) and who have not previously been treated with a biologic treatment (natural substance that is made by using living cells in a laboratory). This is a Phase 4, randomized, open-label, assessor blinded, active comparator study with 2 Parts. Phase 4 studies test treatments that have already been approved to treat patients with a condition or disease. This study is open-label, which means that both participants and study doctors know which study treatment is given to participants
Participants will be administered subcutaneous (SC) treatment of risankizumab every 12 weeks for up to 44 weeks or provided deucravacitinib oral tablets to be taken once daily.
There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular (weekly, monthly) visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Period A: Arm 1 Risankizumab Dose A
Participants will be centrally randomized at the Baseline (Day 1) visit to receive Risankizumab as a single SC injection
Risankizumab
Solution for Subcutaneous (SC) injection
Period A: Arm 2 Deucravacitinib Dose A
Participants will be centrally randomized at the Baseline (Day 1) visit to receive Deucravacitinib orally once per day until the day prior to Week 16
Deucravacitinib
Oral tablet
Period B: Arm 2a Risankizumab Dose A (Continued)
Participants initially randomized to risankizumab (Arm 1) will continue to receive risankizumab as a single SC injection at Weeks 16, 28, and 40
Risankizumab
Solution for Subcutaneous (SC) injection
Period B: Arm 2b Deucravacitinib Dose A
Participants initially randomized to Deucravacitinib (Arm 2) will be re-randomized at the Week 16 visit to receive Deucravacitinib orally once per day up to Week 52
Deucravacitinib
Oral tablet
Period B: Arm 2a Risankizumab Dose A
Participants initially randomized to Deucravacitinib (Arm 2) will be re-randomized at the Week 16 visit to receive Risankizumab as a single SC injection at Weeks 16, 20, 32, and 44
Risankizumab
Solution for Subcutaneous (SC) injection
Interventions
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Risankizumab
Solution for Subcutaneous (SC) injection
Deucravacitinib
Oral tablet
Eligibility Criteria
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Inclusion Criteria
* Stable moderate chronic plaque psoriasis at both Screening and Baseline as defined as:
* Body Surface Area (BSA) ≥ 10% and ≤ 15%,
* Psoriasis Area and Severity Index (PASI) ≥ 12, and
* Static Physician Global Assessment (sPGA) = 3 (moderate) based on a 5-point scale (0 to 4).
* Participant must be a candidate for systemic therapy as assessed by the investigator
* Psoriasis inadequately controlled by topicals, phototherapy and/or systemic treatments (including, but not limited to, methotrexate, apremilast, cyclosporine A, corticosteroids, and/or cyclophosphamide)
Exclusion Criteria
* Participants with a history of current drug-induced PsO or a drug-induced exacerbation of preexisting PsO.
* Participants with a history of active ongoing inflammatory skin diseases other than PsO (with or without PsA) that could interfere with the assessment of PsO (e.g., hyperkeratotic eczema).
* Participants with a history of severe renal insufficiency defined as creatinine clearance \< 30 mL/min and/or requiring hemodialysis or peritoneal dialysis.
* Participantswith a history of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months.
* Participants with a history of an allergic reaction or significant sensitivity to constituents of the study drugs (and its excipients) and/or other products in the same class.
* Participants who have had major surgery performed within 12 weeks prior to randomization or planned during the conduct of the study (e.g., hip replacement, aneurysm removal, stomach ligation).
* Participants with evidence of:
Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, defined as:
* HBV: Hepatitis B surface antigen (HBs Ag) positive (+) test or detected sensitivity on the HBV DNA PCR qualitative test for subjects who are hepatitis B core antibody (HBc Ab) positive (+) (and for hepatitis B surface antibody \[HBs Ab\] positive \[+\] participants where mandated by local requirements).
* HCV: HCV RNA detectable in any participant with anti-HCV antibody (HCV Ab).
* Human immunodeficiency virus (HIV), defined as confirmed positive anti-HIV Ab test and considered to have unstable disease (Unless meeting criteria for stable disease) Participants with HIV with no history of AIDS-defining conditions AND stable disease for at least 6 months prior to screening can be enrolled. Criteria for stable disease is achieved if all below criteria are met. Documentation of "stable disease" can be done at the Screening visit or by documentation of labs performed within 1 month of the Randomization visit, in addition to the subject's medical history.
* On stable antiretroviral therapy;
* Viral load (HIV RNA) below the lower limit of quantification by a validated and approved plasma HIV-1 RNA quantitative assay;
* CD4+ T cell count ≥ 500 cells/μL.
\- Participants with any of the following medical diseases or disorders:
* Recent (within past 6 months) cerebrovascular accident or myocardial infarction;
* History of an organ transplant which requires continued immunosuppression;
* 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.
* Prior history of suicide attempt at any time in the subject's lifetime prior to signing the informed consent and randomization, or major depression or suicidal ideation or attempt requiring hospitalization within the last 3 years prior to signing the informed consent.
* Hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption.
\- Participants who received within 30 days prior to Baseline any:
* Other systemic immunomodulating treatments (including, but not limited to:
e.g., methotrexate, apremilast, cyclosporine A, corticosteroids, cyclophosphamide, tofacitinib \[Xeljanz®\]);
* Other systemic PsO treatments (e.g., retinoids, fumarates, any other drug known to possibly benefit PsO);
* Photochemotherapy (e.g., PUVA), phototherapy (e.g., UVB) or prolonged exposure or use of tanning booths or ultraviolet light sources.
* Participants who received within 14 days prior to Baseline any topical treatment for PsO or any other skin condition (including, but not limited to: e.g., corticosteroids, vitamin D analogues, vitamin A analogues, pimecrolimus, retinoids, salicyl vaseline, salicylic acid, lactic acid, tacrolimus, tar, urea, or anthralin).
* Participants who have been treated with any strong cytochrome P450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin, St. John's Wort) within 30 days or 5 half-lives of start of treatment with deucravacitinib.
* Participants who received any live viral or bacterial vaccine within 4 weeks prior to the first dose of study drug, or expect the need for live vaccination during study participation including at least 147 days (21 weeks or as guided by the local risankizumab label \[if approved\], whichever is longer) after the last dose of risankizumab or at least 30 days after the last dose of deucravacitinib.
* Participants who have been treated with any investigational drug within 30 days or 5 half-lives of the drug (whichever is longer) prior to the first dose of study drug or be currently enrolled in another interventional clinical study.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Total Skin and Beauty Dermatology Center /ID# 263011
Birmingham, Alabama, United States
Advanced Research Associates - Glendale /ID# 263621
Glendale, Arizona, United States
Clear Dermatology & Aesthetics Center /ID# 263626
Scottsdale, Arizona, United States
Dermatology Trial Associates /ID# 264480
Bryant, Arkansas, United States
First OC Dermatology /ID# 263003
Fountain Valley, California, United States
Integrative Skin Science and Research /ID# 264504
Sacramento, California, United States
Physioseq, LLC /ID# 265035
Sacramento, California, United States
Medderm Associates Dermatology /ID# 263858
San Diego, California, United States
Southern California Dermatology /ID# 263021
Santa Ana, California, United States
Clearlyderm Dermatology - West Boca /ID# 264963
Boca Raton, Florida, United States
Driven Research /ID# 263002
Coral Gables, Florida, United States
Skin Care Research - Hollywood /ID# 263877
Hollywood, Florida, United States
International Dermatology Research /ID# 264911
Miami, Florida, United States
Lenus Research and Medical Group /ID# 263886
Miami, Florida, United States
Wellness Clinical Research - Miami Lakes /ID# 263887
Miami Lakes, Florida, United States
Skin Care Research - Tampa /ID# 263880
Tampa, Florida, United States
Advanced Clinical Research Institute /ID# 263878
Tampa, Florida, United States
University Dermatology and Vein Clinic, LLC /ID# 263028
Chicago, Illinois, United States
Arlington Dermatology /ID# 263001
Rolling Meadows, Illinois, United States
Dawes Fretzin, LLC /ID# 264578
Indianapolis, Indiana, United States
MetroBoston Clinical Partners /ID# 263860
Boston, Massachusetts, United States
University of Michigan Health System - Ann Arbor /ID# 265233
Ann Arbor, Michigan, United States
Clinical Research Institute of Michigan - Clinton Township Office /ID# 264968
Clinton Township, Michigan, United States
Dermatology and Skin Center of Lees Summit /ID# 263560
Lee's Summit, Missouri, United States
Physician Research Collaboration, LLC /ID# 263568
Lincoln, Nebraska, United States
Skin Cancer and Dermatology Institute - Reno /ID# 263697
Reno, Nevada, United States
StracSkin, PLLC /ID# 263024
Portsmouth, New Hampshire, United States
Oregon Dermatology & Research Center /ID# 263674
Portland, Oregon, United States
Clinical Partners /ID# 263862
Johnston, Rhode Island, United States
Health Concepts /ID# 263016
Rapid City, South Dakota, United States
Arlington Research Center, Inc /ID# 263908
Arlington, Texas, United States
Bellaire Dermatology Associates /ID# 263897
Bellaire, Texas, United States
U.S. Dermatology Partners - Cedar Park /ID# 263906
Cedar Park, Texas, United States
Dermatology Treatment and Research Center /ID# 267071
Dallas, Texas, United States
Texas Dermatology Research Center /ID# 264487
Plano, Texas, United States
Dermatology Clinical Research Center of San Antonio /ID# 263869
San Antonio, Texas, United States
Center for Clinical Studies - Clear Lake /ID# 263009
Webster, Texas, United States
Center for Clinical Studies - Clear Lake /ID# 263917
Webster, Texas, United States
Premier Clinical Research /ID# 263679
Spokane, Washington, United States
Paratus Clinical Research Woden /ID# 263120
Phillip, Australian Capital Territory, Australia
Premier Dermatology /ID# 263119
Kogarah, New South Wales, Australia
The Skin Hospital - Sydney /ID# 263634
Sydney, New South Wales, Australia
Veracity Clinical Research /ID# 263091
Woolloongabba, Queensland, Australia
Skin Health Institute /ID# 263116
Carlton, Victoria, Australia
Sinclair Dermatology - Melbourne /ID# 262997
East Melbourne, Victoria, Australia
Cliniques Universitaires UCL Saint-Luc /ID# 263106
Brussels, Brussels Capital, Belgium
UZ Gent /ID# 263107
Ghent, Oost-Vlaanderen, Belgium
CHU de Liege /ID# 263108
Liège, , Belgium
Dermatology Research Institute - Blackfoot Trail /ID# 264476
Calgary, Alberta, Canada
Beacon Dermatology Inc /ID# 264266
Calgary, Alberta, Canada
Wiseman Dermatology Research /ID# 265317
Winnipeg, Manitoba, Canada
Toronto Dermatology Centre /ID# 264273
Toronto, Ontario, Canada
Private Practice - Dr. Kim Papp Clinical Research /ID# 264269
Waterloo, Ontario, Canada
Private Practice - Dr. Angelique Gagne-Henley /ID# 264267
Saint-Jérôme, Quebec, Canada
Universitaetsklinikum Freiburg /ID# 263069
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Hautarztpraxis Langenau /ID# 263070
Langenau, Baden-Wurttemberg, Germany
Beldio Research GmbH /ID# 263073
Memmingen, Bavaria, Germany
Dermatologie Mahlow /ID# 263072
Blankenfelde-Mahlow, Brandenburg, Germany
Fachklinik Bad Bentheim /ID# 263066
Bad Bentheim, Lower Saxony, Germany
Universitaetsklinikum Muenster /ID# 263061
Münster, North Rhine-Westphalia, Germany
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 263955
Berlin, , Germany
University General Hospital Attikon /ID# 263421
Athens, Attica, Greece
General Hospital Andreas Syggros /ID# 263418
Athens, Attica, Greece
General Hospital Andreas Syggros /ID# 263708
Athens, Attica, Greece
Hospital of Skin and Venereal Diseases- Thessaloniki /ID# 263419
Thessaloniki, , Greece
Papageorgiou General Hospital /ID# 263414
Thessaloniki, , Greece
Debreceni Egyetem-Klinikai Kozpont /ID# 263484
Debrecen, Hajdú-Bihar, Hungary
Derm-surg /ID# 263799
Kaposvár, Somogy County, Hungary
Semmelweis Egyetem /ID# 263483
Budapest, , Hungary
UNO Medical Trials /ID# 263478
Budapest, , Hungary
Szegedi Tudomanyegyetem /ID# 263800
Szeged, , Hungary
IRCCS Istituto Clinico Humanitas /ID# 263466
Rozzano, Lombardy, Italy
Duplicate_Azienda Ospedaliera Universitaria Federico II /ID# 264034
Naples, Napoli, Italy
IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 263986
Bologna, , Italy
Azienda Ospedaliero Universitaria Pisana /ID# 263468
Pisa, , Italy
Amsterdam UMC, locatie AMC /ID# 263550
Amsterdam, North Holland, Netherlands
Spaarne Gasthuis - Hoofddorp /ID# 263165
Hoofddorp, North Holland, Netherlands
Private Practice - Dr. Alma Cruz /ID# 263212
Carolina, , Puerto Rico
Pan American Center for Oncology Trials /ID# 263206
Rio Piedras, , Puerto Rico
Clinical Research Puerto Rico /ID# 263213
San Juan, , Puerto Rico
GCM Medical Group, PSC /ID# 263198
San Juan, , Puerto Rico
Mindful Medical Research /ID# 263201
San Juan, , Puerto Rico
Hospital General Universitario de Alicante Doctor Balmis /ID# 262977
Alicante, , Spain
Hospital Clinic de Barcelona /ID# 263040
Barcelona, , Spain
Hospital Universitario de La Princesa /ID# 262980
Madrid, , Spain
Victoria Hospital /ID# 262984
Kirkcaldy, Fife, United Kingdom
Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 262981
London, Greater London, United Kingdom
Northern Care Alliance NHS Group /ID# 262983
Salford, , United Kingdom
Countries
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Related Links
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Other Identifiers
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M24-541
Identifier Type: -
Identifier Source: org_study_id