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Study Comparing Risankizumab and Deucravacitinib for Adults with Moderate Plaque Psoriasis Eligible for Systemic Therapy

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effectiveness of two treatments for plaque psoriasis, a skin condition that causes red, scaly patches on the skin. The treatments being compared are risankizumab, known by the code name ABBV-066, and deucravacitinib. Risankizumab is administered as a solution for injection, while deucravacitinib is taken as a film-coated tablet. The purpose of the study is to determine which treatment is more effective for adults with moderate plaque psoriasis who are candidates for systemic therapy, which means they need treatment that affects the entire body.

The study will be conducted over a period of 52 weeks. Participants will be randomly assigned to receive either risankizumab or deucravacitinib. During the first 16 weeks, the effectiveness of each treatment will be assessed. If a participant does not achieve a significant improvement with deucravacitinib, they may switch to risankizumab for the remainder of the study. The main goal is to see if risankizumab can achieve a greater reduction in psoriasis symptoms compared to deucravacitinib.

Throughout the study, participants will be monitored to evaluate the reduction in psoriasis symptoms, using measures such as the Psoriasis Area and Severity Index (PASI) and the static Physician's Global Assessment (sPGA). These assessments help determine the extent of improvement in the skin condition. The study aims to provide valuable information on the best treatment options for individuals with moderate plaque psoriasis.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria. This includes being an adult with moderate plaque psoriasis for at least six months and not having been treated with biologics before.

    The condition should cover 10% to 15% of the body surface area, with a PASI score of 12 or more and a sPGA score of 3.

  2. Step 2

    Initial treatment phase (period a)

    Participants are randomly assigned to receive either deucravacitinib or risankizumab.

    Deucravacitinib is administered orally, while risankizumab is given as a subcutaneous injection.

    The treatment lasts for 16 weeks, during which the effectiveness of the medications is assessed.

  3. Step 3

    Evaluation at week 16

    At the end of 16 weeks, the primary goal is to determine if the treatment has achieved a 90% reduction in the PASI score and an improvement in the sPGA score.

    Participants who do not achieve these results with deucravacitinib may be considered for a switch to risankizumab.

  4. Step 4

    Extended treatment phase (period b)

    Participants who switch to risankizumab continue treatment until week 52.

    The goal is to achieve a 90% reduction in the PASI score by the end of this period.

  5. Step 5

    Final evaluation

    At week 52, the effectiveness of the treatment is evaluated again, focusing on achieving a 100% reduction in the PASI score and a significant improvement in the sPGA score.

Who can join the trial?

8 criteria

  • You must be an adult, which means you are 18 years or older.
  • You should have a condition called **plaque psoriasis**, which is a skin condition that causes red, scaly patches.
  • You should have had this condition for at least 6 months before starting the study.
  • You should not have been treated with **biologics** before. Biologics are special medicines made from living cells to treat certain diseases.
  • Your **body surface area (BSA)** affected by psoriasis should be between 10% and 15%. This means the percentage of your skin that has psoriasis.
  • Your **PASI** score should be 12 or higher. PASI is a way to measure the severity of psoriasis, with higher numbers indicating more severe psoriasis.
  • Your **sPGA** score should be 3, which means your psoriasis is considered moderate. sPGA is a scale from 0 to 4 used to rate the severity of psoriasis.
  • Both men and women can participate in the study.

Who cannot join the trial?

10 criteria

  • Patients who have any other skin conditions that might interfere with the study results.
  • Patients who have a history of severe allergic reactions to any of the study medications.
  • Patients who are currently participating in another clinical trial.
  • Patients who have used certain medications that might affect the study results within a specific time frame before the study starts.
  • Patients who have certain medical conditions that could make it unsafe for them to participate in the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have not followed the study instructions in previous clinical trials.
  • Patients who have certain infections that could affect the study results.
  • Patients who have been vaccinated with live vaccines within a specific time frame before the study starts.
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Investigated drugs

  • Risankizumab

    is a medication used in this trial to treat adults with moderate plaque psoriasis. It works by targeting specific proteins in the immune system that contribute to the inflammation and skin symptoms associated with psoriasis. The trial aims to show that risankizumab is more effective than another treatment in reducing the severity of psoriasis symptoms.

  • Deucravacitinib

    is another medication being tested in this trial for the treatment of moderate plaque psoriasis in adults. It functions by inhibiting certain enzymes that play a role in the immune response, which can help reduce the inflammation and skin lesions seen in psoriasis. The trial compares the effectiveness of deucravacitinib with risankizumab to determine which is more beneficial for patients.

What is already known about the treatment

  • Risankizumab

    This medication is administered via injection and is currently used in the treatment of moderate to severe plaque psoriasis. It is well-documented in medical literature as an effective option for patients who require systemic therapy. Risankizumab works by targeting and inhibiting a specific protein in the immune system called interleukin-23 (IL-23), which plays a key role in the inflammation and overproduction of skin cells seen in psoriasis. It is classified as a monoclonal antibody, which is a type of biologic drug designed to interfere with specific pathways in the immune system.

  • Deucravacitinib

    This medication is taken orally and is used for the treatment of moderate plaque psoriasis. It is recognized in medical literature as a promising option for patients needing systemic therapy. Deucravacitinib functions by selectively inhibiting the tyrosine kinase 2 (TYK2) enzyme, which is involved in the signaling pathways that lead to inflammation and immune response in psoriasis. It belongs to the class of drugs known as Janus kinase (JAK) inhibitors, which are designed to modulate the immune system's activity.

Investigated diseases

Plaque Psoriasis – Plaque psoriasis is a chronic autoimmune condition that primarily affects the skin, leading to the development of thick, red, scaly patches known as plaques. These plaques are often itchy and can appear anywhere on the body, but are most commonly found on the elbows, knees, scalp, and lower back. The condition occurs when the immune system mistakenly attacks healthy skin cells, causing them to multiply rapidly. This results in the buildup of skin cells on the surface, forming the characteristic plaques. The severity of plaque psoriasis can vary, with some individuals experiencing only minor patches, while others may have extensive coverage. The disease often goes through cycles, with periods of flare-ups followed by times of remission.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509738-20-00Protocol codeM24-541Estimated enrolment393 patientsSponsorAbbVie Deutschland GmbH & Co. KG

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).