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
Sites (84)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Skin Health Institute /ID# 263116 Coordinator of this site? Confirm its status | Carlton | Australia | Unknown status |
| Sinclair Dermatology - Melbourne /ID# 262997 Coordinator of this site? Confirm its status | East Melbourne | Australia | Unknown status |
| Premier Dermatology /ID# 263119 Coordinator of this site? Confirm its status | Kogarah | Australia | Unknown status |
| Paratus Clinical Research Woden /ID# 263120 Coordinator of this site? Confirm its status | Phillip | Australia | Unknown status |
| The Skin Hospital - Sydney /ID# 263634 Coordinator of this site? Confirm its status | Sydney | Australia | Unknown status |
| Veracity Clinical Research /ID# 263091 Coordinator of this site? Confirm its status | Woolloongabba | Australia | Unknown status |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Completed |
| Dermatology Research Institute - Blackfoot Trail /ID# 264476 Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| Beacon Dermatology Inc /ID# 264266 Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| Private Practice - Dr. Angelique Gagne-Henley /ID# 264267 Coordinator of this site? Confirm its status | Saint-Jérôme | Canada | Unknown status |
| Toronto Dermatology Centre /ID# 264273 Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Private Practice - Dr. Kim Papp Clinical Research /ID# 264269 Coordinator of this site? Confirm its status | Waterloo | Canada | Unknown status |
| Wiseman Dermatology Research /ID# 265317 Coordinator of this site? Confirm its status | Winnipeg | Canada | Unknown status |
| Thermalsole und Schwefelbad Bentheim GmbH Coordinator of this site? Confirm its status | Bad Bentheim | Germany | Completed |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Completed |
| Fachaerztliche Gemeinschaftspraxis fuer Dermatologie Und Venerologie Allergologie Umweltmedizin Lasermedizin GbR Coordinator of this site? Confirm its status | Blankenfelde-Mahlow | Germany | Completed |
| Medical Center- University of Freiburg Coordinator of this site? Confirm its status | Freiburg im Breisgau | Germany | Completed |
| Studienzentrum Dr. Schwarz Coordinator of this site? Confirm its status | Langenau | Germany | Completed |
| Beldio Research Gmbh Coordinator of this site? Confirm its status | Memmingen | Germany | Completed |
| Universitaet Muenster Coordinator of this site? Confirm its status | Muenster | Germany | Completed |
| Hospital General Universitario Dr. Balmis Coordinator of this site? Confirm its status | Alicante | Spain | Completed |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital Universitario de la Princesa Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Victoria Hospital /ID# 262984 Coordinator of this site? Confirm its status | Kirkcaldy | United Kingdom | Unknown status |
| Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 262981 Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Northern Care Alliance NHS Group /ID# 262983 Coordinator of this site? Confirm its status | Salford | United Kingdom | Unknown status |
| University General Hospital Attikon Coordinator of this site? Confirm its status | Athens | Greece | Completed |
| Andreas Syngros Hospital Of Venereal And Dermatological Diseases Coordinator of this site? Confirm its status | Athens | Greece | Completed |
| General Hospital Of Thessaloniki Papageorgiou Coordinator of this site? Confirm its status | Efkarpia | Greece | Completed |
| Ippokratio General Hospital of Thessaloniki Coordinator of this site? Confirm its status | Thessaloniki | Greece | Completed |
| Semmelweis University Coordinator of this site? Confirm its status | Budapest VIII | Hungary | Completed |
| Uno Medical Trials Kft. Coordinator of this site? Confirm its status | Budapest XV | Hungary | Completed |
| University of Debrecen Coordinator of this site? Confirm its status | Debrecen | Hungary | Completed |
| Derm-Surg Kft. Coordinator of this site? Confirm its status | Kaposvar | Hungary | Completed |
| University of Szeged Coordinator of this site? Confirm its status | Szeged | Hungary | Completed |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico Coordinator of this site? Confirm its status | Bologna | Italy | Completed |
| Azienda Ospedaliero Universitaria Pisana Coordinator of this site? Confirm its status | Pisa | Italy | Completed |
| Humanitas Research Hospital Coordinator of this site? Confirm its status | Rozzano | Italy | Completed |
| Amsterdam UMC Stichting Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Completed |
| Spaarne Gasthuis Stichting Coordinator of this site? Confirm its status | Haarlem | Netherlands | Completed |
| Private Practice - Dr. Alma Cruz /ID# 263212 Coordinator of this site? Confirm its status | Carolina | Puerto Rico | Unknown status |
| Pan American Center for Oncology Trials /ID# 263206 Coordinator of this site? Confirm its status | Rio Piedras | Puerto Rico | Unknown status |
| Mindful Medical Research /ID# 263201 Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| GCM Medical Group, PSC /ID# 263198 Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| Clinical Research Puerto Rico /ID# 263213 Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| University of Michigan Health System - Ann Arbor /ID# 265233 Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| Arlington Research Center, Inc /ID# 263908 Coordinator of this site? Confirm its status | Arlington | United States | Unknown status |
| Bellaire Dermatology Associates /ID# 263897 Coordinator of this site? Confirm its status | Bellaire | United States | Unknown status |
| Total Skin and Beauty Dermatology Center /ID# 263011 Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Clearlyderm Dermatology - West Boca /ID# 264963 Coordinator of this site? Confirm its status | Boca Raton | United States | Unknown status |
| MetroBoston Clinical Partners /ID# 263860 Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Dermatology Trial Associates /ID# 264480 Coordinator of this site? Confirm its status | Bryant | United States | Unknown status |
| U.S. Dermatology Partners - Cedar Park /ID# 263906 Coordinator of this site? Confirm its status | Cedar Park | United States | Unknown status |
| University Dermatology and Vein Clinic, LLC /ID# 263028 Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Clinical Research Institute of Michigan - Clinton Township Office /ID# 264968 Coordinator of this site? Confirm its status | Clinton Township | United States | Unknown status |
| Driven Research /ID# 263002 Coordinator of this site? Confirm its status | Coral Gables | United States | Unknown status |
| Dermatology Treatment and Research Center /ID# 267071 Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| First OC Dermatology /ID# 263003 Coordinator of this site? Confirm its status | Fountain Valley | United States | Unknown status |
| Advanced Research Associates - Glendale /ID# 263621 Coordinator of this site? Confirm its status | Glendale | United States | Unknown status |
| Skin Care Research - Hollywood /ID# 263877 Coordinator of this site? Confirm its status | Hollywood | United States | Unknown status |
| Dawes Fretzin, LLC /ID# 264578 Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| Clinical Partners /ID# 263862 Coordinator of this site? Confirm its status | Johnston | United States | Unknown status |
| Dermatology and Skin Center of Lees Summit /ID# 263560 Coordinator of this site? Confirm its status | Lee's Summit | United States | Unknown status |
| Physician Research Collaboration, LLC /ID# 263568 Coordinator of this site? Confirm its status | Lincoln | United States | Unknown status |
| International Dermatology Research /ID# 264911 Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Lenus Research and Medical Group /ID# 263886 Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Wellness Clinical Research - Miami Lakes /ID# 263887 Coordinator of this site? Confirm its status | Miami Lakes | United States | Unknown status |
| Texas Dermatology Research Center /ID# 264487 Coordinator of this site? Confirm its status | Plano | United States | Unknown status |
| Oregon Dermatology & Research Center /ID# 263674 Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| StracSkin, PLLC /ID# 263024 Coordinator of this site? Confirm its status | Portsmouth | United States | Unknown status |
| Health Concepts /ID# 263016 Coordinator of this site? Confirm its status | Rapid City | United States | Unknown status |
| Skin Cancer and Dermatology Institute - Reno /ID# 263697 Coordinator of this site? Confirm its status | Reno | United States | Unknown status |
| Arlington Dermatology /ID# 263001 Coordinator of this site? Confirm its status | Rolling Meadows | United States | Unknown status |
| Integrative Skin Science and Research /ID# 264504 Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| Physioseq, LLC /ID# 265035 Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| Dermatology Clinical Research Center of San Antonio /ID# 263869 Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Medderm Associates Dermatology /ID# 263858 Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| Southern California Dermatology /ID# 263021 Coordinator of this site? Confirm its status | Santa Ana | United States | Unknown status |
| Clear Dermatology & Aesthetics Center /ID# 263626 Coordinator of this site? Confirm its status | Scottsdale | United States | Unknown status |
| Premier Clinical Research /ID# 263679 Coordinator of this site? Confirm its status | Spokane | United States | Unknown status |
| Skin Care Research - Tampa /ID# 263880 Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Advanced Clinical Research Institute /ID# 263878 Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Center for Clinical Studies - Clear Lake /ID# 263009 Coordinator of this site? Confirm its status | Webster | United States | Unknown status |
| Center for Clinical Studies - Clear Lake /ID# 263917 Coordinator of this site? Confirm its status | Webster | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.