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Study of Risankizumab vs. Placebo for Patients with Active Psoriatic Arthritis and Inadequate Response to DMARD 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 effects of a medication called Risankizumab on individuals with Psoriatic Arthritis. Psoriatic Arthritis is a type of arthritis that affects some people who have psoriasis, a condition that features red patches of skin topped with silvery scales. The study involves comparing Risankizumab to a placebo to see how well it works in treating the symptoms of Psoriatic Arthritis. Risankizumab is given as a solution for injection using a pre-filled syringe.

The purpose of the study is to evaluate the effectiveness of Risankizumab in reducing the signs and symptoms of Psoriatic Arthritis in participants who have not responded well to or cannot tolerate at least one previous treatment known as a Disease Modifying Anti-Rheumatic Drug (DMARD). Participants will receive either Risankizumab or a placebo, and the study will monitor their progress over a period of time to assess improvements in their condition.

Throughout the study, participants will receive regular injections and attend scheduled visits to track their health and any changes in their symptoms. The study aims to determine if Risankizumab can provide significant relief from the symptoms of Psoriatic Arthritis compared to the placebo. The trial is designed to ensure that all participants are closely monitored for safety and effectiveness of the treatment.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm the diagnosis of psoriatic arthritis and to ensure the presence of active disease. This includes checking for psoriatic plaques or nail changes and reviewing previous treatment responses.

  2. Step 2

    Randomization

    Participants are randomly assigned to receive either risankizumab or a placebo. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.

  3. Step 3

    Treatment administration

    The treatment involves subcutaneous injections. Participants receive risankizumab at a dose of 150 mg or a placebo, administered through a pre-filled syringe.

  4. Step 4

    Treatment period

    The treatment period lasts for 24 weeks. During this time, participants continue to receive their assigned treatment and attend regular study visits for monitoring and assessment.

  5. Step 5

    Primary assessment

    At week 24, the primary assessment is conducted to evaluate the proportion of participants achieving an ACR20 response, which measures improvement in arthritis symptoms.

  6. Step 6

    Secondary assessments

    Secondary assessments include evaluating changes in physical function, skin symptoms, and other health indicators. These assessments occur at various points, including weeks 16 and 24.

  7. Step 7

    End of study

    The study is estimated to conclude by July 29, 2026. Participants will have a final assessment to determine the overall impact of the treatment on their condition.

Who can join the trial?

6 criteria

  • The patient must have a clinical diagnosis of Psoriatic Arthritis (PsA), which means they have been diagnosed with this condition, and symptoms must have started at least 6 months before the screening visit.
  • The patient must have active disease at the start of the study.
  • The patient must have a diagnosis of active plaque psoriasis, which is a skin condition, with at least one psoriatic plaque that is 2 centimeters or larger, or nail changes that are consistent with psoriasis at the screening visit.
  • The patient must have either at least one erosion visible on an X-ray, as determined by a central imaging review, or a high level of hs-CRP (a marker of inflammation in the blood) of 3.0 mg/L or higher at the screening visit.
  • The patient must have shown an inadequate response, meaning the treatment did not work well enough, after at least 12 weeks of therapy with at least one csDMARD (a type of medication used to treat PsA) at the highest dose they can tolerate.
  • Both male and female patients are eligible to participate in the study.

Who cannot join the trial?

10 criteria

  • Patients who have any other serious health conditions that could interfere with the study.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had a recent infection that required treatment with antibiotics.
  • Patients who have a history of allergic reactions to similar medications.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have received certain treatments for Psoriatic Arthritis recently.
  • Patients who have a weakened immune system.
  • Patients who have been diagnosed with certain types of cancer.
  • Patients who have had a recent vaccination with a live vaccine.
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Investigated drugs

Risankizumab is a medication used in this clinical trial to treat individuals with active psoriatic arthritis. It is being tested to see how effective it is in reducing the signs and symptoms of the condition. This medication is being compared to a placebo to determine its effectiveness in patients who have not responded well to or cannot tolerate at least one other type of treatment known as disease-modifying anti-rheumatic drugs (DMARDs).

What is already known about the treatment

Risankizumab – This medication is administered as an injection and is currently being studied in clinical trials for its effectiveness in treating psoriatic arthritis. It is primarily used for patients who have not responded well to other treatments. Risankizumab works by targeting a specific protein in the immune system, helping to reduce inflammation and symptoms associated with the condition. It is classified as a monoclonal antibody, which is a type of biologic drug designed to interfere with specific pathways in the immune response.

Investigated diseases

Psoriatic Arthritis – Psoriatic arthritis is a chronic inflammatory condition that affects both the skin and joints. It typically occurs in individuals with psoriasis, a skin disease characterized by red, scaly patches. The disease can cause joint pain, stiffness, and swelling, often affecting fingers, toes, and the spine. Over time, psoriatic arthritis can lead to joint damage and reduced mobility if not managed properly. The severity and progression of symptoms can vary widely among individuals. Some people may experience mild symptoms, while others may have more severe joint involvement.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505478-14-00Protocol codeM16-011Estimated enrolment799 patientsSponsorAbbVie Deutschland GmbH & Co. KG

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