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Study on Izokibep for Improving Symptoms in Patients with Active Psoriatic Arthritis

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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 treatment called Izokibep on individuals with Psoriatic Arthritis. Psoriatic Arthritis is a condition that causes joint pain and swelling, often associated with the skin condition psoriasis. The study aims to determine if Izokibep can improve symptoms of this disease and assess its safety. Izokibep is administered as a solution for injection under the skin.

The trial involves comparing the effects of Izokibep with a placebo to see how well it works. Participants will receive either Izokibep or a placebo and will be monitored over a period of time to observe any changes in their symptoms. The main goal is to see if there is a 50% improvement in joint symptoms by the 16th week of the study.

Throughout the study, participants will have regular check-ups to monitor their health and any side effects. The study will also look at other aspects of Psoriatic Arthritis, such as the resolution of inflammation in certain areas and overall quality of life improvements. This research is important for understanding how effective Izokibep is in treating Psoriatic Arthritis and ensuring its safety for patients.

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 visit

    Upon joining the study, you will attend an initial visit. During this visit, you will receive detailed information about the study, and you will be asked to provide your signed informed consent. This consent confirms your agreement to participate and comply with the study requirements.

    You will undergo a screening process to ensure you meet the study criteria. This includes a test for tuberculosis (TB) and a review of your medical history to confirm no active TB and no known exposure to TB.

  2. Step 2

    Baseline assessment

    At the baseline assessment, your psoriatic arthritis symptoms will be evaluated. This includes checking for swollen and tender joints.

    You will also be asked about your previous treatments and responses to medications such as NSAIDs, csDMARDs, and TNFi.

  3. Step 3

    Randomization and treatment

    You will be randomly assigned to receive either the study medication, izokibep, or a placebo. The study is double-blind, meaning neither you nor the study team will know which treatment you are receiving.

    If you receive izokibep, it will be administered as a subcutaneous injection (under the skin). The dosage will be 160 mg, given either once a week (QW) or once every two weeks (Q2W).

  4. Step 4

    Treatment period

    The treatment period lasts for 16 weeks. During this time, you will continue to receive your assigned treatment according to the schedule.

    You will be required to attend regular study visits to monitor your health and the effects of the treatment. This includes checking your joint symptoms and overall health.

  5. Step 5

    End of treatment assessment

    At the end of the 16-week treatment period, you will undergo a final assessment. This will evaluate the effectiveness of the treatment in improving your psoriatic arthritis symptoms.

    The study team will also check for any side effects or changes in your health during the study.

Who can join the trial?

12 criteria

  • The person must have signed a form agreeing to participate in the study and follow the study rules.
  • The person must not have a known history of active tuberculosis (TB), which is a serious lung infection.
  • The person must have a negative TB test at the start of the study. If the test is positive, they can still participate if they have no TB symptoms, have started preventive treatment, have not been exposed to active TB, and have a clear chest X-ray.
  • Men and women must use birth control during the study and for at least 8 weeks after the last dose of the study drug. Men must use condoms, and women must use a highly effective birth control method.
  • The person must be between 18 and 75 years old.
  • The person must have a clinical diagnosis of Psoriatic Arthritis (PsA) for at least 6 months and meet specific criteria for this condition.
  • The person must have active PsA, shown by having at least 3 swollen and 3 tender joints at the start of the study.
  • The person must test negative for rheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP), which are markers for another type of arthritis.
  • The person must have tried and not responded well to, or cannot take, at least one of the following treatments: NSAID (a type of pain reliever), csDMARD (a type of medication for arthritis), or TNFi (a type of medication that blocks a specific protein in the body).
  • If the person is using certain medications like methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, or apremilast, they must have been on a stable dose for at least 4 weeks before starting the study drug.
  • If the person is using corticosteroids (a type of medication that reduces inflammation), they must have been on a stable dose not exceeding 7.5 mg per day for at least 4 weeks before starting the study drug.
  • If the person is using NSAIDs or low potency opioid medications like tramadol, they must have been on a stable dose for at least 2 weeks before starting the study drug.

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 within a specific time frame before the study.
  • Patients who have been vaccinated with a live vaccine within a certain period before the study.
  • Patients who have a history of certain types of cancer.
  • Patients who have a history of certain blood disorders.
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Investigated drugs

Izokibep is a medication being studied for its potential to help people with active psoriatic arthritis, a condition that causes joint pain and swelling. This medication works by targeting specific proteins in the body that are involved in inflammation, which is a key part of psoriatic arthritis. By reducing inflammation, Izokibep aims to improve symptoms like joint pain and swelling, helping patients feel better and move more easily. The study is looking at how effective and safe Izokibep is for people with this condition.

What is already known about the treatment

Izokibep – Izokibep is administered through injections, typically given once a week or every two weeks, to help manage symptoms of psoriatic arthritis, a condition that causes joint pain and skin issues. Currently, it is being studied in clinical trials to confirm its effectiveness and safety for this condition. Izokibep works by targeting specific proteins in the body that are involved in inflammation, helping to reduce pain and swelling in the joints. It belongs to a class of medications known as biologics, which are designed to interfere with the processes that cause inflammation in autoimmune diseases.

Investigated diseases

Psoriatic Arthritis – Psoriatic Arthritis is a chronic inflammatory disease that affects the joints and areas where tendons and ligaments connect to bone. It often occurs in people who have psoriasis, a skin condition characterized by red, scaly patches. The disease can cause joint pain, stiffness, and swelling, which may worsen over time. It typically affects the fingers, toes, and lower back, but can involve any joint. As the disease progresses, it can lead to joint damage and reduced range of motion. The severity and progression can vary widely among individuals.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2022-501362-22-00Protocol code22104Estimated enrolment312 patientsSponsorAcelyrin Inc.

sourced from the EU Clinical Trials Register and site verification

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