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Study on Deucravacitinib and Apremilast for Patients with Active Psoriatic Arthritis New to Biologic Treatments or Previously on TNFα Inhibitors

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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 deucravacitinib on individuals with Psoriatic Arthritis, a condition that causes joint pain and swelling along with skin symptoms. The study will compare the effectiveness and safety of deucravacitinib with a placebo. Participants in the study may have never used biologic treatments for their condition or may have previously been treated with medications known as TNFα inhibitors.

The purpose of the study is to evaluate how well deucravacitinib works in treating active psoriatic arthritis. Participants will receive either deucravacitinib or a placebo, and the study will monitor their progress over a period of time. The medication is taken orally in the form of film-coated tablets. The study will assess various health outcomes, including improvements in joint pain and skin symptoms, over several weeks.

Throughout the study, participants will be regularly checked to see how their condition is responding to the treatment. The study aims to provide valuable information on whether deucravacitinib can be an effective treatment option for people with psoriatic arthritis, potentially offering relief from the symptoms associated with this condition.

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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm the diagnosis of psoriatic arthritis (PsA) for at least 3 months.

    The assessment includes meeting the Classification Criteria for Psoriatic Arthritis (CASPAR) and checking for active plaque psoriatic skin lesions or a documented history of plaque psoriasis.

    Active arthritis is confirmed by the presence of at least 3 swollen joints and 3 tender joints, along with a high sensitivity C-reactive protein (hsCRP) level of 3 mg/L or higher.

  2. Step 2

    Randomization and treatment allocation

    Participants are randomly assigned to receive either deucravacitinib 6 mg tablets or a placebo, both taken orally.

    The treatment is administered in a double-blind manner, meaning neither the participant nor the study team knows which treatment is being given.

  3. Step 3

    Treatment phase

    The treatment phase involves taking the assigned medication daily.

    Participants are monitored regularly to assess the efficacy and safety of the treatment.

  4. Step 4

    Evaluation of primary and secondary outcomes

    The primary outcome is the proportion of participants achieving a 20% improvement in symptoms, as defined by the American College of Rheumatology (ACR20).

    Secondary outcomes include changes in disease activity scores, physical function, and quality of life measures at Week 16.

  5. Step 5

    End of study procedures

    At the end of the study, participants undergo final assessments to evaluate the overall impact of the treatment.

    The study is estimated to conclude by November 3, 2026.

Who can join the trial?

7 criteria

  • The patient must have been diagnosed with psoriatic arthritis for at least 3 months before the screening. Psoriatic arthritis is a type of arthritis that affects some people with the skin condition psoriasis.
  • The patient must meet the CASPAR criteria for psoriatic arthritis at the time of screening. CASPAR criteria are a set of guidelines used to diagnose psoriatic arthritis.
  • The patient must have active plaque psoriasis skin lesions or a documented medical history of plaque psoriasis at the time of screening. Plaque psoriasis is a skin condition that causes red, scaly patches on the skin.
  • The patient must have active arthritis, which means having at least 3 swollen joints and at least 3 tender joints at the time of screening and on the first day of the study.
  • The patient must have a high level of C-reactive protein (hsCRP) in their blood, which is 3 mg/L or higher at the time of screening. C-reactive protein is a substance produced by the liver in response to inflammation.
  • The study is open to both male and female participants.
  • The study includes participants from vulnerable populations, which means it may include people who are at a higher risk of harm or exploitation.

Who cannot join the trial?

9 criteria

  • Having any other active disease that affects the immune system, which is the body's defense system against illnesses.
  • Currently having a serious infection, which is an illness caused by harmful germs like bacteria or viruses.
  • Having a history of cancer, which is a disease where cells in the body grow uncontrollably.
  • Being pregnant or breastfeeding, as the study may affect the baby.
  • Using certain medications that might interfere with the study treatment.
  • Having a history of drug or alcohol abuse, which means using substances in a harmful way.
  • Having a known allergy to the study medication or its ingredients.
  • Participating in another clinical trial at the same time.
  • Having a condition that the study doctors believe would make it unsafe to participate.
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Investigated drugs

Deucravacitinib is a medication being studied for its effectiveness and safety in treating people with active psoriatic arthritis. It is designed to help reduce inflammation and improve symptoms in patients who have not previously used biologic treatments or have used TNFα inhibitors.

What is already known about the treatment

Deucravacitinib – This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating active psoriatic arthritis. It is in the phase 3 stage of clinical trials, indicating that it is being evaluated for safety and efficacy before potential approval for widespread use. Deucravacitinib is primarily indicated for individuals with active psoriatic arthritis, especially those who are either new to biologic treatments or have previously used TNFα inhibitors. The drug works by selectively inhibiting the enzyme tyrosine kinase 2 (TYK2), which plays a role in the inflammatory process associated with psoriatic arthritis. It is classified as a Janus kinase (JAK) inhibitor, a type of medication that targets specific pathways involved in inflammation.

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 worsen over time. It often affects the fingers and toes, leading to a sausage-like appearance known as dactylitis. Enthesitis, or inflammation where tendons and ligaments attach to bone, is also common. The progression of psoriatic arthritis can vary, with periods of increased symptoms followed by times of remission.
Trial detailsLast updated 9 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506257-37-00Protocol codeIM011-055Estimated enrolment1 110 patientsSponsorBristol-Myers Squibb Services Unlimited Company

sourced from the EU Clinical Trials Register and site verification

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