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Study on Tildrakizumab for Patients with Active Psoriatic Arthritis Who Have Not 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 trial will compare the effects of Tildrakizumab to a placebo to see how well it works and how safe it is for people who have not previously been treated with anti-TNF medications, which are drugs that reduce inflammation by blocking a protein called tumor necrosis factor.

The purpose of the study is to evaluate the effectiveness and safety of Tildrakizumab in people with active Psoriatic Arthritis. Participants in the study will receive either Tildrakizumab or a placebo and will be monitored over a period of 24 weeks. During this time, researchers will assess how many participants experience a 20% improvement in their symptoms, as well as monitor any side effects.

This study aims to provide valuable information about the potential benefits and risks of using Tildrakizumab for treating Psoriatic Arthritis. By participating, individuals will contribute to research that could lead to better treatment options for this condition in the future.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase
The study begins with the administration of the investigational medication, tildrakizumab, or a placebo. This is done through a subcutaneous injection, which means the medication is injected under the skin.
The medication is provided in a pre-filled syringe, containing either Ilumetri 100 mg or a placebo solution. The exact dosage and frequency of administration will be determined by the study protocol.
Step 2
Ongoing treatment and monitoring
Participants will continue to receive the assigned treatment over a period of 24 weeks. During this time, regular monitoring will occur to assess the effectiveness and safety of the treatment.
Participants may be required to maintain stable doses of any concurrent medications, such as methotrexate, leflunomide, or oral corticosteroids, unless adjustments are needed due to side effects.
Step 3
Evaluation of treatment response
At the end of the 24-week period, the primary goal is to evaluate the proportion of participants who achieve a 20% improvement in symptoms, as measured by the American College of Rheumatology response criteria, known as ACR20.
Secondary evaluations will include assessments of more significant improvements, such as ACR50 and ACR70, as well as changes in physical function and skin condition.
Step 4
Completion of study participation
Upon completion of the study, participants will undergo a final assessment to determine the overall impact of the treatment on their condition.
The study is expected to conclude by August 2025, with all data collected and analyzed to understand the efficacy and safety of tildrakizumab for treating psoriatic arthritis.

Who can join the trial?

12 criteria

The person must have given written permission to participate in the study.
If taking **methotrexate** (a medication for arthritis) or **leflunomide** (another arthritis medication), the person must have been on a stable dose for at least 3 months and continue the same dose for the first 24 weeks of the study. They cannot take both medications at the same time.
If taking **oral corticosteroids** (a type of medication that reduces inflammation), the person must be on a stable dose not exceeding the equivalent of 10 mg of **prednisone** per day for at least 4 weeks before starting the study and continue the same dose for the first 24 weeks.
The person must have a negative test for **tuberculosis (TB)** within 4 weeks before starting the study. If the test is positive or unclear, additional checks are needed to ensure no active TB is present.
The person must be 18 years or older at the time of the study screening.
The person must have been diagnosed with active **Psoriatic Arthritis (PsA)** for at least 6 months and have active symptoms at the time of screening and the start of the study.
The person must have at least 3 tender and 3 swollen joints at screening and the start of the study. **Dactylitis** (swelling of a finger or toe) counts as one joint for eligibility.
The person 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 person must have active **plaque psoriasis (PsO)**, with at least one psoriatic plaque of 2 cm or more in diameter at screening or a history of plaque psoriasis.
The person must not have previously used **anti-tumor necrosis factor (anti-TNF)** agents for treating Psoriasis or Psoriatic Arthritis.
If taking **non-steroidal anti-inflammatory drugs (NSAIDs)** or low-strength painkillers like tramadol, meperidine, or codeine, the person must be on a stable dose for at least 4 weeks before starting the study and continue the same dose for the first 24 weeks, unless a change is needed due to side effects.
If receiving non-drug therapies like physical therapy, massage, diet, exercise, skin moisturizers, or joint taping, these must be stable for the 4 weeks before starting the study and continue through the study period.

Who cannot join the trial?

4 criteria

Patients who have previously been treated with medications known as anti-Tumour Necrosis Factor (TNF) therapies. These are drugs used to reduce inflammation in certain conditions.
Patients who do not have active psoriatic arthritis, which is a type of arthritis that affects some people with the skin condition psoriasis.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Clinicmed Daniluk Nowak Sp. k.
Bialystok, Poland
Responsive
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, Spain
Verified
Hospital Universitario da A Coruna
A Coruna Galicia, Spain

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Investigated drugs

Tildrakizumab is a medication being studied for its effectiveness and safety in treating individuals with active psoriatic arthritis who have not previously received anti-TNF therapy. It is designed to help reduce inflammation and improve symptoms by targeting specific pathways in the immune system. The goal of the trial is to see if patients experience a significant improvement in their condition, specifically a 20% reduction in symptoms, after 24 weeks of treatment.

Tildrakizumab

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 and safety in treating psoriatic arthritis, particularly in patients who have not previously received anti-TNF therapy. It is primarily used for managing psoriatic arthritis, a condition characterized by joint inflammation and skin lesions. Tildrakizumab works by targeting and inhibiting a specific protein called interleukin-23 (IL-23), which plays a role in the inflammatory process associated with psoriatic arthritis. It is classified as a monoclonal antibody, a type of biologic medication 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 worsen over time. It often affects the fingers and toes, leading to a sausage-like appearance known as dactylitis. The progression of psoriatic arthritis can vary, with periods of increased symptoms followed by times of remission. Over time, it can lead to joint damage and reduced physical function if not managed properly.