Not recruitingRare disease

Study on Ustekinumab and Drug Combination for Patients with Severe, Resistant Inflammatory Disease

Verified siteRegistered drugNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This clinical trial is focused on studying treatments for patients with a severe and resistant inflammatory disease that affects multiple organs. The disease is not classified under any specific category and can impact areas such as the skin, lymph nodes, blood-forming system, joints, digestive tract, eyes, nerves, brain, respiratory system, heart, blood vessels, urinary system, and muscles. The study aims to evaluate the effectiveness of personalized treatments that are chosen based on a detailed analysis of the patient's specific inflammatory pathways.

The treatments being tested in this study include several medications: Ustekinumab, Secukinumab, Adalimumab, Anakinra, Rituximab, and Tocilizumab. These medications are administered through injections, either under the skin or directly into the bloodstream. Each medication works by targeting specific parts of the immune system to reduce inflammation and improve symptoms.

Participants in the study will receive one of these treatments, or a placebo, over a period of several months. The main goal is to see if there is an improvement in the disease's activity, particularly in the skin and other affected areas. The study will monitor changes in symptoms and biological markers of inflammation to determine the effectiveness of the treatments. The results will help in understanding how these targeted therapies can benefit patients with complex inflammatory diseases.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient will be informed about the trial's objective, which is to evaluate the effectiveness of targeted treatments for severe and resistant inflammatory diseases.
The patient must provide signed informed consent to participate in the study.
Step 2
Initial assessment
The patient will undergo a comprehensive assessment to confirm the presence of a non-classified inflammatory disease affecting at least two organs, with mandatory skin involvement.
The disease must have been resistant to at least two prior treatments.
Step 3
Treatment selection
A personalized treatment plan will be developed using an algorithm based on molecular analysis of the patient's specific inflammatory pathways.
The treatment options include medications such as ustekinumab, secukinumab, adalimumab, anakinra, rituximab, and tocilizumab.
Step 4
Treatment administration
The selected medication will be administered according to its specific route: subcutaneous injection for ustekinumab, secukinumab, adalimumab, and anakinra; intravenous perfusion for rituximab; and intravenous infusion for tocilizumab.
The frequency and dosage will be determined based on the patient's individual treatment plan.
Step 5
Monitoring and evaluation
The patient's response to the treatment will be monitored regularly, with a primary evaluation at six months after treatment initiation.
Improvement will be assessed based on systemic activity, skin involvement, and biological markers of inflammation.
Step 6
End of trial
The trial is expected to conclude by November 20, 2025.
The patient's overall response and any improvements in quality of life will be documented and analyzed.

Who can join the trial?

8 criteria

Patients must be **18 years old or older**.
Both **men and women** can participate.
Patients must have an **inflammatory disease** that affects at least two different parts of the body, such as the skin, lymph nodes, blood-forming system, joints, digestive system, eyes, nerves and brain, breathing system, heart and blood vessels, urinary system including kidneys, or muscles and bones.
**Skin involvement** is required to compare affected and unaffected areas.
Patients must sign a **consent form** agreeing to participate.
The disease must be **non-classified**, meaning it doesn't fit into a known category, even after thorough testing and expert evaluation.
The disease must **significantly affect the patient's quality of life**, as determined by the study investigator.
The disease must have been **resistant to at least two previous treatments**. Examples of these treatments include Hydroxychloroquine, Chloroquine, Colchicine, Methotrexate, Ciclosporine, Azathioprine, Mycophenolate mofetil, Disulone, and Corticosteroids like prednisone or dexamethasone.

Who cannot join the trial?

4 criteria

Patients with a **non-classified, severe, and resistant inflammatory disease** cannot participate. This means if the inflammation is not clearly identified, is very serious, and does not respond to usual treatments, the patient is excluded.
Patients who are not within the specified **age range** for the study are excluded. The age range is not specified here, but it means only certain ages can participate.
Patients who are not part of the specified **clinical trial group** are excluded. This means only certain groups of people, based on specific criteria, can join the study.
Patients who are part of a **vulnerable population** are excluded. Vulnerable populations might include people who are at higher risk of harm or who cannot give informed consent easily.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

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

Verified
Centre Hospitalier Lyon Sud
Pierre Benite, France
Verified
Centre Hospitalier Universitaire De Lille
Lille, France
Verified
Hopital Beaujon
Clichy, France

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

PIMOC is a personalized targeted therapy designed for patients with severe and resistant inflammatory diseases. This therapy is tailored to each patient based on a detailed molecular analysis of their specific inflammatory signaling pathways. The goal is to provide a treatment that directly targets the underlying causes of the inflammation, potentially improving outcomes for patients who have not responded to traditional treatments.

What is already known about the treatment

PIMOC – This medication is administered orally and is currently being evaluated in clinical trials for its effectiveness in treating severe and resistant inflammatory diseases that do not fit into a specific classification. The main therapeutic indication is for patients with complex multi-organ inflammatory conditions. At the molecular level, PIMOC works by targeting specific altered inflammatory signaling pathways, which are identified through molecular analysis, allowing for personalized treatment. It is classified pharmacologically as a targeted therapy, aiming to modulate the immune response and reduce inflammation.

Investigated diseases

Inflammatory Disease – This condition is characterized by the body's immune system attacking its own tissues, leading to inflammation. It can affect various parts of the body, including the skin, joints, and internal organs. Symptoms often include redness, swelling, pain, and heat in the affected areas. The disease can be severe and resistant to standard treatments, making it challenging to manage. It may progress unpredictably, with periods of flare-ups and remissions. The exact cause is often unknown, and it may not fit into a specific classification, requiring personalized treatment approaches.