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NCT06333860CompletedPhase 4

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)

A Phase 4 Multicenter, Randomized, Open-label, Efficacy Assessor Blinded Study of Risankizumab Compared to Deucravacitinib for the Treatment of Adult Subjects With Moderate Plaque Psoriasis Who Are Candidates for Systemic Therapy

Source: ClinicalTrials.gov · Last updated 15 Apr 2026

Brief summary (registry, in English)

Psoriasis is a long-term skin disease which causes red, itchy, scaly patches most commonly on the knees, elbows, scalp, and torso (chest, back, and abdomen). In participants with psoriasis, certain skin cells multiply much faster and the skin can develop rough patches that may be red or white with scales. There are many types of psoriasis, but plaque psoriasis is the most common. The exact cause of psoriasis is unknown, but researchers think it may be caused by the body's immune system not working properly. 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.

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
393 (actual)
First submitted
21 Mar 2024
Start date
10 May 2024
Primary completion date
19 Mar 2026
Lead sponsor
AbbVie
Diseases
Psoriasis
NCT number
NCT06333860
EU CT number
2023-509738-20-00

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 393
  • From 10 May 2024 to the primary completion date, 19 Mar 2026
  • 84 sites in 12 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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).
  • 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;
  • 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.
  • 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.

Other illness

  • 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).
  • 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 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).
  • Viral load (HIV RNA) below the lower limit of quantification by a validated and approved plasma HIV-1 RNA quantitative assay;
  • 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.

Lab values

  • Participants with a history of severe renal insufficiency defined as creatinine clearance \< 30 mL/min and/or requiring hemodialysis or peritoneal dialysis.
  • CD4+ T cell count ≥ 500 cells/μL.
    • \- Participants with any of the following medical diseases or disorders:
  • Hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption.
    • \- Participants who received within 30 days prior to Baseline any:

Other

  • Participants with any form of PsO other than chronic plaque PsO (e.g., pustular PsO, palmoplantar pustulosis, acrodermatitis of Hallopeau, erythrodermic, or guttate PsO).

Who the study is looking for

  • Participant with a diagnosis of chronic plaque psoriasis (PsO) with or without psoriatic arthritis, for at least 6 months prior to Baseline.
  • 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)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (84)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Skin Health Institute /ID# 263116
Coordinator of this site? Confirm its status
CarltonAustraliaUnknown status
Sinclair Dermatology - Melbourne /ID# 262997
Coordinator of this site? Confirm its status
East MelbourneAustraliaUnknown status
Premier Dermatology /ID# 263119
Coordinator of this site? Confirm its status
KogarahAustraliaUnknown status
Paratus Clinical Research Woden /ID# 263120
Coordinator of this site? Confirm its status
PhillipAustraliaUnknown status
The Skin Hospital - Sydney /ID# 263634
Coordinator of this site? Confirm its status
SydneyAustraliaUnknown status
Veracity Clinical Research /ID# 263091
Coordinator of this site? Confirm its status
WoolloongabbaAustraliaUnknown status
Universitair Ziekenhuis Gent
Coordinator of this site? Confirm its status
GentBelgiumCompleted
Dermatology Research Institute - Blackfoot Trail /ID# 264476
Coordinator of this site? Confirm its status
CalgaryCanadaUnknown status
Beacon Dermatology Inc /ID# 264266
Coordinator of this site? Confirm its status
CalgaryCanadaUnknown status
Private Practice - Dr. Angelique Gagne-Henley /ID# 264267
Coordinator of this site? Confirm its status
Saint-JérômeCanadaUnknown status
Toronto Dermatology Centre /ID# 264273
Coordinator of this site? Confirm its status
TorontoCanadaUnknown status
Private Practice - Dr. Kim Papp Clinical Research /ID# 264269
Coordinator of this site? Confirm its status
WaterlooCanadaUnknown status
Wiseman Dermatology Research /ID# 265317
Coordinator of this site? Confirm its status
WinnipegCanadaUnknown status
Thermalsole und Schwefelbad Bentheim GmbH
Coordinator of this site? Confirm its status
Bad BentheimGermanyCompleted
Charite Universitaetsmedizin Berlin KöR
Coordinator of this site? Confirm its status
BerlinGermanyCompleted
Fachaerztliche Gemeinschaftspraxis fuer Dermatologie Und Venerologie Allergologie Umweltmedizin Lasermedizin GbR
Coordinator of this site? Confirm its status
Blankenfelde-MahlowGermanyCompleted
Medical Center- University of Freiburg
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Freiburg im BreisgauGermanyCompleted
Studienzentrum Dr. Schwarz
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LangenauGermanyCompleted
Beldio Research Gmbh
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MemmingenGermanyCompleted
Universitaet Muenster
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MuensterGermanyCompleted
Hospital General Universitario Dr. Balmis
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AlicanteSpainCompleted
Hospital Clinic de Barcelona
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BarcelonaSpainCompleted
Hospital Universitario de la Princesa
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MadridSpainCompleted
Victoria Hospital /ID# 262984
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KirkcaldyUnited KingdomUnknown status
Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 262981
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
Northern Care Alliance NHS Group /ID# 262983
Coordinator of this site? Confirm its status
SalfordUnited KingdomUnknown status
University General Hospital Attikon
Coordinator of this site? Confirm its status
AthensGreeceCompleted
Andreas Syngros Hospital Of Venereal And Dermatological Diseases
Coordinator of this site? Confirm its status
AthensGreeceCompleted
General Hospital Of Thessaloniki Papageorgiou
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EfkarpiaGreeceCompleted
Ippokratio General Hospital of Thessaloniki
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ThessalonikiGreeceCompleted
Semmelweis University
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Budapest VIIIHungaryCompleted
Uno Medical Trials Kft.
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Budapest XVHungaryCompleted
University of Debrecen
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DebrecenHungaryCompleted
Derm-Surg Kft.
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KaposvarHungaryCompleted
University of Szeged
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SzegedHungaryCompleted
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Coordinator of this site? Confirm its status
BolognaItalyCompleted
Azienda Ospedaliero Universitaria Pisana
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PisaItalyCompleted
Humanitas Research Hospital
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RozzanoItalyCompleted
Amsterdam UMC Stichting
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AmsterdamNetherlandsCompleted
Spaarne Gasthuis Stichting
Coordinator of this site? Confirm its status
HaarlemNetherlandsCompleted
Private Practice - Dr. Alma Cruz /ID# 263212
Coordinator of this site? Confirm its status
CarolinaPuerto RicoUnknown status
Pan American Center for Oncology Trials /ID# 263206
Coordinator of this site? Confirm its status
Rio PiedrasPuerto RicoUnknown status
Mindful Medical Research /ID# 263201
Coordinator of this site? Confirm its status
San JuanPuerto RicoUnknown status
GCM Medical Group, PSC /ID# 263198
Coordinator of this site? Confirm its status
San JuanPuerto RicoUnknown status
Clinical Research Puerto Rico /ID# 263213
Coordinator of this site? Confirm its status
San JuanPuerto RicoUnknown status
University of Michigan Health System - Ann Arbor /ID# 265233
Coordinator of this site? Confirm its status
Ann ArborUnited StatesUnknown status
Arlington Research Center, Inc /ID# 263908
Coordinator of this site? Confirm its status
ArlingtonUnited StatesUnknown status
Bellaire Dermatology Associates /ID# 263897
Coordinator of this site? Confirm its status
BellaireUnited StatesUnknown status
Total Skin and Beauty Dermatology Center /ID# 263011
Coordinator of this site? Confirm its status
BirminghamUnited StatesUnknown status
Clearlyderm Dermatology - West Boca /ID# 264963
Coordinator of this site? Confirm its status
Boca RatonUnited StatesUnknown status
MetroBoston Clinical Partners /ID# 263860
Coordinator of this site? Confirm its status
BostonUnited StatesUnknown status
Dermatology Trial Associates /ID# 264480
Coordinator of this site? Confirm its status
BryantUnited StatesUnknown status
U.S. Dermatology Partners - Cedar Park /ID# 263906
Coordinator of this site? Confirm its status
Cedar ParkUnited StatesUnknown status
University Dermatology and Vein Clinic, LLC /ID# 263028
Coordinator of this site? Confirm its status
ChicagoUnited StatesUnknown status
Clinical Research Institute of Michigan - Clinton Township Office /ID# 264968
Coordinator of this site? Confirm its status
Clinton TownshipUnited StatesUnknown status
Driven Research /ID# 263002
Coordinator of this site? Confirm its status
Coral GablesUnited StatesUnknown status
Dermatology Treatment and Research Center /ID# 267071
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DallasUnited StatesUnknown status
First OC Dermatology /ID# 263003
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Fountain ValleyUnited StatesUnknown status
Advanced Research Associates - Glendale /ID# 263621
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GlendaleUnited StatesUnknown status
Skin Care Research - Hollywood /ID# 263877
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HollywoodUnited StatesUnknown status
Dawes Fretzin, LLC /ID# 264578
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IndianapolisUnited StatesUnknown status
Clinical Partners /ID# 263862
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JohnstonUnited StatesUnknown status
Dermatology and Skin Center of Lees Summit /ID# 263560
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Lee's SummitUnited StatesUnknown status
Physician Research Collaboration, LLC /ID# 263568
Coordinator of this site? Confirm its status
LincolnUnited StatesUnknown status
International Dermatology Research /ID# 264911
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MiamiUnited StatesUnknown status
Lenus Research and Medical Group /ID# 263886
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MiamiUnited StatesUnknown status
Wellness Clinical Research - Miami Lakes /ID# 263887
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Miami LakesUnited StatesUnknown status
Texas Dermatology Research Center /ID# 264487
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PlanoUnited StatesUnknown status
Oregon Dermatology & Research Center /ID# 263674
Coordinator of this site? Confirm its status
PortlandUnited StatesUnknown status
StracSkin, PLLC /ID# 263024
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PortsmouthUnited StatesUnknown status
Health Concepts /ID# 263016
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Rapid CityUnited StatesUnknown status
Skin Cancer and Dermatology Institute - Reno /ID# 263697
Coordinator of this site? Confirm its status
RenoUnited StatesUnknown status
Arlington Dermatology /ID# 263001
Coordinator of this site? Confirm its status
Rolling MeadowsUnited StatesUnknown status
Integrative Skin Science and Research /ID# 264504
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SacramentoUnited StatesUnknown status
Physioseq, LLC /ID# 265035
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SacramentoUnited StatesUnknown status
Dermatology Clinical Research Center of San Antonio /ID# 263869
Coordinator of this site? Confirm its status
San AntonioUnited StatesUnknown status
Medderm Associates Dermatology /ID# 263858
Coordinator of this site? Confirm its status
San DiegoUnited StatesUnknown status
Southern California Dermatology /ID# 263021
Coordinator of this site? Confirm its status
Santa AnaUnited StatesUnknown status
Clear Dermatology & Aesthetics Center /ID# 263626
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ScottsdaleUnited StatesUnknown status
Premier Clinical Research /ID# 263679
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SpokaneUnited StatesUnknown status
Skin Care Research - Tampa /ID# 263880
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TampaUnited StatesUnknown status
Advanced Clinical Research Institute /ID# 263878
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TampaUnited StatesUnknown status
Center for Clinical Studies - Clear Lake /ID# 263009
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WebsterUnited StatesUnknown status
Center for Clinical Studies - Clear Lake /ID# 263917
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WebsterUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.