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Study on Tildrakizumab for Patients with Active Psoriatic Arthritis Who Have Previously Used Anti-TNF 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 Psoriatic Arthritis, a condition that causes joint pain and swelling in people who have psoriasis, a skin disease. The study is testing a treatment called Tildrakizumab, which is given as an injection under the skin. The purpose of the study is to evaluate how effective and safe Tildrakizumab is for people who have previously been treated with anti-TNF medications, which are drugs that help reduce inflammation in the body.

Participants in the study will receive either Tildrakizumab or a placebo, which looks like the treatment but does not contain the active medicine. The study will last for 24 weeks, during which time participants will receive regular injections and have their health monitored by the study team. The main goal is to see if participants experience a 20% improvement in their symptoms by the end of the study period.

Throughout the study, the safety and tolerability of Tildrakizumab will be closely observed to ensure that it is safe for use in treating Psoriatic Arthritis. Participants will have regular check-ups to monitor their progress and any potential side effects. This study aims to provide valuable information on the effectiveness of Tildrakizumab for individuals with this condition.

The research process

The trial runs in 6 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 eligibility. This includes a review of medical history and current medications.

    A negative tuberculosis (TB) test is required within four weeks before starting the study medication. If TB is detected, appropriate treatment must be completed before participation.

  2. Step 2

    Baseline evaluation

    A baseline evaluation is performed to document the current state of psoriatic arthritis. This includes checking for at least three tender and three swollen joints.

    The presence of active psoriatic arthritis is confirmed, and any existing psoriatic plaques are noted.

  3. Step 3

    Medication administration

    The study involves the administration of tildrakizumab or a placebo. Tildrakizumab is given as a subcutaneous injection.

    The dosage is 100 mg, administered through a pre-filled syringe. The frequency and duration of administration are determined by the study protocol.

  4. Step 4

    Ongoing treatment

    Participants receiving methotrexate or leflunomide must maintain a stable dose for the first 24 weeks of the study. Methotrexate should not exceed 25 mg per week, and leflunomide should not exceed 20 mg per day.

    For those on oral corticosteroids, the dose should not exceed the equivalent of 10 mg of prednisone per day and must remain stable for the first 24 weeks.

  5. Step 5

    Monitoring and evaluation

    Participants are monitored regularly to assess the efficacy and safety of the treatment. This includes evaluating the reduction in symptoms and any side effects.

    The primary goal is to achieve a 20% reduction in symptoms by week 24, as measured by specific criteria.

  6. Step 6

    Study completion

    The study is expected to conclude by December 23, 2025. Participants will undergo a final evaluation to document the outcomes of the treatment.

    The results will contribute to understanding the effectiveness and safety of tildrakizumab for treating psoriatic arthritis.

Who can join the trial?

12 criteria

  • The patient must have given written permission to participate in the study.
  • If the patient is taking methotrexate (MTX) or leflunomide, they must have been on this treatment for at least 3 months, with a stable dose for at least 8 weeks before starting the study medication. The dose should not exceed 25 mg of MTX per week or 20 mg of leflunomide per day. The patient should not be taking both medications at the same time.
  • If the patient is taking oral corticosteroids, they must be on a stable dose (not more than the equivalent of 10 mg of prednisone per day) for at least 4 weeks before starting the study medication.
  • The patient must have a negative test for tuberculosis (TB) within 4 weeks before starting the study medication. If the test is positive or unclear, the patient can still participate if they have no history or symptoms of active TB, a clear chest X-ray, and have followed treatment guidelines for latent TB if needed.
  • The patient must be 18 years or older at the time of the study screening.
  • The patient must have been diagnosed with active **Psoriatic Arthritis (PsA)** for at least 6 months and have active PsA confirmed at the screening and start of the study.
  • The patient must have at least 3 tender and 3 swollen joints at the screening and start of the study.
  • The patient must test negative for **rheumatoid factor (RF)** and **anti-cyclic citrullinated peptide antibodies (anti-CCP Ab)**, which are markers often found in other types of arthritis.
  • The patient must have active **plaque psoriasis (PsO)**, with at least one psoriatic plaque of 2 cm or larger, or a history of plaque PsO.
  • The patient must have previously used anti-tumor necrosis factor (anti-TNF) agents for treating PsO or PsA.
  • If the patient is taking non-steroidal anti-inflammatory drugs (NSAIDs) or low potency opioids like tramadol, meperidine, or codeine, they must be on a stable dose for at least 4 weeks before starting the study medication.
  • If the patient is receiving non-drug therapies like physical therapy, massage, diet, exercise, or joint taping, these must be stable for the 4 weeks before starting the study medication and continue to be stable through the study period.

Who cannot join the trial?

3 criteria

  • Patients who have not experienced treatment with anti-TNF medications. Anti-TNF medications are drugs used to reduce inflammation in conditions like arthritis.
  • Patients who do not have active psoriatic arthritis. Active means that the symptoms of the disease are currently present and noticeable.
  • Patients who are part of a vulnerable population. This refers to groups of people who might be at higher risk of harm or exploitation, such as children or those with certain disabilities.
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Investigated drugs

Tildrakizumab is a medication being studied for its effectiveness and safety in treating people with active psoriatic arthritis who have previously been treated with anti-TNF medications. The goal of the study is to see if this medication can help reduce the symptoms of psoriatic arthritis, such as joint pain and swelling, by at least 20% after 24 weeks of treatment. The study also aims to ensure that the medication is safe and well-tolerated by the participants.

What is already known about the treatment

Tildrakizumab – Tildrakizumab is administered via subcutaneous injection and is currently being studied in clinical trials for its effectiveness in treating psoriatic arthritis, particularly in patients who have previously been treated with anti-TNF therapies. It is a monoclonal antibody that targets interleukin-23 (IL-23), a protein involved in inflammatory processes, thereby reducing inflammation and symptoms associated with psoriatic arthritis. Tildrakizumab is classified as an immunosuppressive agent and is being evaluated for its ability to improve joint symptoms and overall quality of life in affected individuals.

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. The progression of the disease can vary, with periods of increased symptoms followed by times of remission. It can also lead to changes in the nails, such as pitting or separation from the nail bed.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507415-35-00Protocol codeTILD-19-07Estimated enrolment436 patientsSponsorSun Pharmaceutical Industries Limited

sourced from the EU Clinical Trials Register and site verification

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