Not recruitingRare disease

A study to test if tibulizumab works and is safe for adults with systemic sclerosis

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What is this trial about?

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

This study involves people with systemic sclerosis, a condition where the body produces too much connective tissue, leading to hardening and tightening of the skin and sometimes affecting internal organs like the lungs. The study will test a medicine called tibulizumab, which is given as an injection under the skin. Some people in the study will receive placebo instead of the actual medicine during the first part of the study.

The purpose of the study is to find out if tibulizumab can reduce skin thickness in people with systemic sclerosis and to check how safe the medicine is when used over time. The study is divided into two periods. In the first period, which lasts 24 weeks, participants will be randomly assigned to receive either tibulizumab or placebo, and neither the participants nor the doctors will know which treatment is being given. In the second period, all participants will receive tibulizumab for an additional 28 weeks, and everyone will know they are receiving the actual medicine.

During the study, doctors will measure skin thickness using a scoring system, check lung function through breathing tests that measure how much air the lungs can hold, and use special scans to look at the lungs in detail. Participants will also complete questionnaires about their ability to perform daily activities. Throughout both periods, the study team will monitor for any unwanted effects of the treatment by checking vital signs, heart activity, and blood test results. The total treatment time for each participant can be up to 48 weeks.

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 assignment
Upon joining the study, you will be randomly assigned to one of two groups. This random assignment is similar to flipping a coin and determines which treatment you will receive during the first part of the study.
One group will receive tibulizumab, which is the medication being tested. The other group will receive a placebo, which looks identical but contains no active medication.
During this phase, neither you nor your doctor will know which treatment you are receiving. This is called a double-blind period and helps ensure the results are accurate and unbiased.
Step 2
Period 1: Double-blind treatment phase
This first period lasts for 24 weeks (approximately 6 months).
You will receive either tibulizumab or placebo through subcutaneous injection. A subcutaneous injection means the medication is injected under the skin using a needle.
The medication is provided as a solution for injection, which is a liquid form ready to be injected.
The specific dosage and frequency of injections will be determined by the study protocol and explained to you by the study staff.
During this period, your skin thickness will be measured using the modified Rodnan Skin Score, which is a method to assess how thick and tight your skin is in different areas of your body.
Your lung function will be tested by measuring forced vital capacity, which checks how much air you can forcefully exhale after taking a deep breath.
You will have high-resolution computed tomography scans of your lungs to assess any lung tissue changes.
Your ability to perform daily activities will be evaluated using the Health Assessment Questionnaire Disability Index, which asks questions about tasks like dressing, eating, and walking.
Throughout this period, any side effects or health changes you experience will be recorded and monitored.
Step 3
Period 2: Open-label extension phase
After completing the first 24 weeks, you will enter the second period of the study called the open-label extension.
During this phase, all participants will receive tibulizumab. Both you and your doctor will know that you are receiving the active medication.
This period continues until Week 52 (approximately 1 year from the start of the study).
You will continue to receive tibulizumab through subcutaneous injection at the same intervals as before.
Your skin thickness will continue to be measured using the modified Rodnan Skin Score.
Safety monitoring will continue throughout this period, including regular checks of your vital signs such as blood pressure, heart rate, and temperature.
You will have electrocardiograms, which are tests that record the electrical activity of your heart.
Blood and other laboratory tests will be performed regularly to monitor your overall health and check for any changes.
Any side effects or health concerns will continue to be documented and assessed.
Step 4
Ongoing monitoring and assessments
Throughout both periods of the study, you will attend regular clinic visits for assessments and to receive your injections.
At each visit, the study staff will check your overall health and ask about any symptoms or side effects you may be experiencing.
Lung imaging with high-resolution computed tomography will be repeated at specified times to track any changes in your lung tissue.
Your lung function will be tested repeatedly by measuring how much air you can breathe out, which helps assess if your lung capacity is changing.
The thickness and tightness of your skin will be regularly measured at multiple body sites to track any improvements or changes.
You will complete questionnaires about your ability to perform everyday activities to see if the treatment affects your quality of life.
All test results, measurements, and any health changes will be carefully recorded throughout your participation in the study.

Who can join the trial?

10 criteria

You must understand the written informed consent form, provide signed and witnessed written informed consent, and agree to follow the study requirements.
You must be between 18 and 75 years old at the time of signing the informed consent.
Your Body Mass Index (BMI) must be between 18.0 and 38.0. BMI is a measure of body fat based on your height and weight.
You must have Systemic Sclerosis that meets the classification criteria set by ACR and EULAR from 2013. These are medical organizations that have defined specific standards for diagnosing this condition.
You must have diffuse cutaneous Systemic Sclerosis, which means the condition affects large areas of your skin.
Your first symptom or sign of Systemic Sclerosis (other than Raynaud's phenomenon, which is a condition where fingers and toes turn white or blue in response to cold or stress) must have appeared no more than 7 years ago at the time of signing consent.
Your modified Rodnan Skin Score (mRSS) must be between 15 and 45 at the screening visit. This is a measurement of how thick and tight your skin is in different areas of your body. Additional requirements apply if you have had symptoms for 2 to 7 years and test positive for RNA Polymerase 3, which is a specific antibody found in some patients.
Your Forced Vital Capacity (FVC) must be greater than 50% of the predicted normal value at screening and on Day 1. FVC is a breathing test that measures how much air you can forcefully exhale from your lungs.
Your Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) must be at least 40% of the predicted normal value (adjusted for hemoglobin, which is a protein in red blood cells that carries oxygen) at screening. This test measures how well oxygen passes from your lungs into your blood.
You must agree to follow the contraception requirements defined in the study protocol.

Who cannot join the trial?

4 criteria

The specific exclusion criteria (reasons why patients cannot participate) have not been provided in the available study information
Exclusion criteria are conditions or factors that would prevent someone from safely joining the study
These criteria help protect patient safety and ensure the study results are accurate
For this particular study about systemic sclerosis (a disease where the skin and internal organs become thick and hard), the detailed list of who cannot participate is not available in the current documentation

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Verified sites

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

Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
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Cracow, Poland
Hospital De La Santa Creu I Sant Pau
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Barcelona, Spain
M2m Med. Sp. z o.o.
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Chorzow, Poland
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Investigated drugs

Tibulizumab
is an investigational medication being studied for the treatment of systemic sclerosis, a condition that causes thickening and hardening of the skin and can affect internal organs. This medication is designed to help reduce skin thickness in patients with this condition. In this study, tibulizumab will be given to participants to evaluate how well it works and whether it is safe and well-tolerated.
Placebo
is an inactive substance that looks like the real medication but contains no active treatment. It is used in the first part of this study to compare the effects of tibulizumab against no treatment, helping researchers determine if tibulizumab is truly effective.

What is already known about the treatment

Tibulizumab – Tibulizumab is an investigational medication currently being studied in clinical trials for the treatment of systemic sclerosis, a chronic autoimmune disease that causes hardening and tightening of the skin and connective tissues. This drug is administered as an injection and works by targeting specific molecules in the immune system that contribute to the excessive tissue scarring and thickening characteristic of this condition. The medication is being evaluated in a phase 2 study to determine its effectiveness in reducing skin thickness, as well as to assess its safety and tolerability in adults with systemic sclerosis. Tibulizumab belongs to a class of medications called monoclonal antibodies, which are designed to selectively block certain proteins involved in the disease process.

Investigated diseases

Systemic Sclerosis – Systemic sclerosis is a chronic autoimmune disease that affects the connective tissue throughout the body. The condition causes the skin to become thick and hard due to excessive collagen production. As the disease progresses, it can affect internal organs including the lungs, heart, kidneys, and digestive system. The skin changes typically begin in the fingers and hands, then may spread to other areas of the body. Patients often experience tightening and hardening of the skin, which can limit movement and flexibility. The disease can also cause inflammation and scarring in the lungs, leading to breathing difficulties.