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Study of Risankizumab vs. Placebo for Patients with Active Psoriatic Arthritis Who Have Not Responded Well to Previous Biologic Treatments

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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 condition that causes joint pain and swelling, often occurring in people who have psoriasis, a skin condition characterized by red, scaly patches. The study will compare the effectiveness of Risankizumab, which is given as an injection, to a placebo. Risankizumab is also known by its code name, ABBV-066.

The purpose of the study is to evaluate how well Risankizumab works in reducing the signs and symptoms of Psoriatic Arthritis. Participants in the study will receive either Risankizumab or a placebo through injections. The study will monitor the participants over a period of time to assess improvements in their condition. The main goal is to see if participants achieve a significant reduction in their symptoms by the 24th week of the study.

Throughout the study, various health assessments will be conducted to measure changes in the participants' condition. These assessments will help determine the effectiveness of Risankizumab in managing Psoriatic Arthritis symptoms. The study aims to provide valuable information on whether Risankizumab can be a beneficial treatment option for individuals with this condition, especially for those who have not responded well to other treatments in the past.

The research process

The trial runs in 4 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, a clinical diagnosis of psoriatic arthritis is confirmed. Symptoms must have started at least six months before the screening visit.

    Active disease is confirmed at the baseline visit. A diagnosis of active plaque psoriasis with at least one psoriatic plaque of 2 centimeters or more in diameter or nail changes consistent with psoriasis is required.

    A history of inadequate response or intolerance to previous biologic or csDMARD therapies is documented.

  2. Step 2

    Initial treatment phase

    Participants receive either risankizumab or a placebo. Risankizumab is administered as a solution for injection in a pre-filled syringe.

    The medication is given subcutaneously, which means it is injected under the skin.

    The dosage of risankizumab is 150 mg.

  3. Step 3

    Monitoring and assessment

    Participants are monitored for their response to the treatment. The primary goal is to assess the proportion of participants achieving an ACR20 response by Week 24.

    Secondary assessments include changes in health questionnaires and the proportion of participants achieving various response levels, such as ACR50 and ACR70, by Week 24.

    Additional evaluations include the resolution of specific symptoms like enthesitis and dactylitis.

  4. Step 4

    Conclusion of the study

    The study is estimated to conclude by April 16, 2026.

    Final assessments are conducted to evaluate the overall effectiveness and safety of risankizumab compared to the placebo.

Who can join the trial?

6 criteria

  • You must have a clinical diagnosis of Psoriatic Arthritis (PsA), which means your doctor has confirmed you have this condition, and your symptoms must have started at least 6 months before the screening visit.
  • You need to meet the Classification Criteria for PsA (CASPAR) at the screening visit. This is a set of guidelines doctors use to confirm PsA.
  • You must have active disease at the start of the study, meaning your PsA symptoms are currently present and noticeable.
  • You should have a diagnosis of active plaque psoriasis, which is a skin condition with red, scaly patches. You need to have at least one psoriatic plaque that is 2 centimeters or larger, or nail changes that are typical of psoriasis, at the screening visit.
  • You must have shown an inadequate response or intolerance to previous treatments, which could include biologic therapies or csDMARD therapies. These are types of medications used to treat PsA.
  • Both male and female participants are eligible to join the study.

Who cannot join the trial?

4 criteria

  • Patients who have a different condition than Psoriatic Arthritis cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
  • Patients who do not meet the specific health requirements set by the study cannot participate.
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Investigated drugs

Risankizumab is a medication being studied for its effectiveness in treating active psoriatic arthritis. It is designed to help reduce the signs and symptoms of this condition, especially in patients who have not responded well to other biological therapies or have experienced side effects from them.

What is already known about the treatment

Risankizumab – Risankizumab is administered as an injection under the skin, typically in the form of a pre-filled syringe. It is currently being studied in clinical trials for its effectiveness in treating psoriatic arthritis, especially in patients who have not responded well to other biological therapies. The medication works by targeting and inhibiting a specific protein in the immune system known as interleukin-23 (IL-23), which plays a role in inflammation and the overproduction of skin cells. Risankizumab is classified as a monoclonal antibody, a type of biologic drug designed to interfere with specific pathways in the immune system to reduce inflammation and improve symptoms.

Investigated diseases

Psoriatic Arthritis – Psoriatic arthritis is a chronic inflammatory condition that affects both the skin and joints. It is associated with psoriasis, a skin disease characterized by red, scaly patches. The disease can cause joint pain, stiffness, and swelling, which may lead to joint damage over time. Symptoms often vary in severity and can affect any joint in the body, including the spine and fingers. The progression of psoriatic arthritis can be unpredictable, with periods of increased symptoms followed by times of remission. It is important to monitor the condition to manage symptoms effectively.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505477-33-00Protocol codeM15-998Estimated enrolment333 patientsSponsorAbbVie Deutschland GmbH & Co. KG

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