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)

Completed · Phase 4

Conditions studied: Moderate Plaque Psoriasis

In brief

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.

Key facts

Study ID

NCT06333860

Run by

AbbVie

People needed

393

Starts

2024-05-10

Expected to finish

2026-03-19

Last updated by the study team

2026-04-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

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

Where it is running

• 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
• Total Skin and Beauty Dermatology Center /ID# 263011 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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