Recruiting

Tulisokibart for Psoriatic Arthritis in Adults

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical study is being done in psoriatic arthritis, a disease that can cause joint pain, swelling, and stiffness in people who also have psoriasis, a skin condition that can cause red, scaly patches. The study is testing tulisokibart, given as an injection, and it is being compared with placebo. The purpose of the study is to learn whether tulisokibart is safe and whether it can help reduce the signs and symptoms of psoriatic arthritis.

People in the study are assigned by chance to receive either tulisokibart or placebo, and neither the participants nor the study team knows which treatment is given during the study. Treatment is given over a period of time, and the main comparison is made after about 16 weeks. During the study, health checks are done to see how the disease and any side effects change over time.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Start of the study
After joining the study, you are placed into one of two treatment groups in a random way. This means the group is assigned by chance.
The study is double-blind, which means that the treatment you receive is hidden during the study. You may receive either tulisokibart or a placebo (a treatment with no active medicine).
Step 2
Study treatment period
You receive the assigned study treatment during the trial. Tulisokibart is given as a solution for injection in a pre-filled injector. The source data does not provide the dose, frequency, or exact duration of treatment.
If you are assigned to the placebo group, you receive placebo to mk-7240. The source data does not provide the dose, frequency, or exact duration of placebo administration.
Step 3
Week 16 assessment
At week 16, your response to the study treatment is checked. The main measure is whether you reach ACR20, which means at least a 20% improvement in arthritis signs and symptoms.
At the same time, the study also checks whether you reach ACR50 and ACR70. These mean 50% and 70% improvement, respectively.
Your physical function is also assessed using the HAQ-DI, which stands for health assessment questionnaire disability index. This is a measure of how much difficulty you have with daily activities.
The study records whether you have any adverse events, meaning unwanted medical problems or side effects, and whether any side effects lead you to stop the study treatment.

Who can join the trial?

5 criteria

Have a confirmed clinical diagnosis of psoriatic arthritis (a doctor has diagnosed the condition), with symptoms that started at least 6 months before screening.
Have active disease, meaning at least 3 tender joints and at least 3 swollen joints. Tender joints are joints that hurt when touched or moved, and swollen joints are joints that look enlarged because of inflammation.
Have active plaque psoriasis or a documented history of plaque psoriasis. Plaque psoriasis is a type of psoriasis that causes raised, scaly patches on the skin.
Have had an inadequate response to certain disease-modifying antirheumatic drugs (DMARDs) or have not been able to tolerate them. Inadequate response means the medicine did not work well enough, and intolerance means the medicine caused side effects that made it hard to continue.
If taking any study-required medicines during the trial, meet the required stable dose or stable treatment period rules. Stable means the dose or treatment has stayed the same for the required amount of time before joining the study.

Who cannot join the trial?

13 criteria

Any arthritis that started before age 17, or any current inflammatory joint disease other than psoriatic arthritis, such as rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, or myositis, or any other condition that could make it hard to judge the study results.
Major surgery within the past 3 months before screening, or any major surgery planned during the study. Major surgery means an operation that needs general anesthesia, which is medicine used to make a person fully asleep during surgery.
Joint surgery on any joint that will be checked in the study within 8 weeks before randomization. Randomization means being assigned to a study treatment by chance.
Not having had enough benefit from, not being able to tolerate, or having taken a targeted synthetic DMARD for at least 8 weeks. A DMARD is a medicine that helps reduce joint disease activity and damage.
An injection into a joint, trigger point, tender point, bursa, or tendon sheath within 8 weeks before randomization. These are places where medicine can be injected to reduce pain or inflammation.
A skin condition other than psoriasis that could interfere with judging the psoriasis results.
Fibromyalgia that was active within the past 12 months, or fibromyalgia that could affect the study results. Fibromyalgia is a condition that can cause widespread pain and tiredness.
A transplanted organ and the need to keep taking systemic immunosuppressive medicine. Immunosuppressive medicine lowers the activity of the immune system.
A history of cancer, except for fully treated nonmelanoma skin cancer or cervical carcinoma in situ after complete surgical removal, if the person has been free of disease for less than 5 years before randomization. Cervical carcinoma in situ means very early cancer cells in the cervix that have not spread.
Test results or medical imaging, such as chest or breast scans, that suggest cancer may be present and cannot be ruled out after further checks.
Known infection with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV).
Any active infection.
Active tuberculosis.

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Verified sites

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

Verified
Charite Universitaetsmedizin Berlin KöR
Berlin, Germany
Verified
Hospital Universitario Y Politecnico La Fe
Valencia, Spain
Verified
Hospital Vall d’Hebron
Barcelona, Spain

Trial locations

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Investigated drugs

tulisokibart is the study medicine being tested in this trial. It is given as an injection using a pre-filled injector. The goal of the study is to see whether it can help reduce the signs and symptoms of psoriatic arthritis better than placebo, and to check how safe it is for people taking it.

Tulisokibart

What is already known about the treatment

tulisokibart - Tulisokibart is given as a solution for injection in a pre-filled injector, so it is administered by injection under the skin or by another planned injection method used in the study. It is an experimental medicine that is still being studied in clinical trials, and it is not yet a widely established treatment in everyday medical practice. It is being tested for psoriatic arthritis, a condition that causes joint pain, swelling, and stiffness, and it is designed to calm down the immune system by blocking a specific target involved in inflammation, which may help reduce these symptoms. Based on its use in research, it is classified as an anti-inflammatory biologic medicine and, more specifically, an immune-system targeted therapy.

Investigated diseases

Psoriatic arthritis - Psoriatic arthritis is a long-term inflammatory disease that causes joint pain, stiffness, and swelling, often in people who have psoriasis. It usually develops gradually, but some people have periods when symptoms worsen and then improve. The disease can affect the fingers, toes, knees, ankles, spine, and the places where tendons and ligaments attach to bone. Over time, ongoing inflammation may lead to reduced joint movement and joint damage.