RecruitingRare disease

Study on the Safety of T-Guard (Dafsolimab Setaritox, Grisnilimab Setaritox) for Patients with Early Diffuse Cutaneous Systemic Sclerosis

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 trial is focused on studying a condition known as diffuse cutaneous systemic sclerosis (dcSSc), which is a type of autoimmune disease that affects the skin and sometimes other organs. The trial will use a treatment called T-Guard, which is a solution for injection or infusion. T-Guard contains two active substances: dafsolimab setaritox and grisnilimab setaritox. These substances are proteins designed to target and reduce the activity of certain immune cells that are involved in the disease process.

The main purpose of the study is to evaluate the safety of T-Guard in patients with early stages of dcSSc. Participants in the study will receive T-Guard through an intravenous infusion, which means it will be administered directly into a vein. The study will monitor participants for any side effects or adverse events that may occur during and after the treatment. This includes tracking any serious or infectious side effects for up to 365 days after the treatment begins.

Throughout the study, various health assessments will be conducted to observe changes in the condition of the participants. These assessments will include skin evaluations, lung function tests, and quality of life questionnaires. The study aims to gather information on how T-Guard affects the progression of dcSSc and its impact on the participants' overall health and well-being. Participants will be closely monitored to ensure their safety and to collect valuable data on the effectiveness of the treatment.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.
Eligibility criteria include being aged 18-75, having early diffuse cutaneous systemic sclerosis (dcSSc), and having tried at least two systemic immunosuppressive treatments without success.
Step 2
Treatment administration
The treatment involves the administration of T-Guard, a solution for injection or infusion.
The medication is given through an intravenous infusion. The specific dosage and frequency are determined by the study protocol.
Step 3
Monitoring period
After receiving the treatment, there is a monitoring period to observe any side effects or adverse events.
The primary focus is on identifying any Grade 3 or higher adverse events within 28 days after the last administration of T-Guard.
Step 4
Follow-up assessments
Follow-up assessments occur at various intervals: 90, 180, 270, and 365 days after treatment start.
These assessments include evaluating skin scores, lung function, and quality of life measures.
Step 5
Long-term observation
The study continues to observe participants for up to 365 days to monitor for any long-term effects or outcomes.
This includes tracking any serious adverse events, infections, and overall health status.

Who can join the trial?

7 criteria

Must be between 18 and 75 years old at the time of signing the consent form.
Must have early **diffuse cutaneous systemic sclerosis (dcSSc)**, which means skin involvement above and below the elbows and/or knees, and the disease should have started within the last 36 months from the first non-Raynaud symptom.
Must have a **Modified Rodnan Skin Score (MRSS)** of 15 or higher. This is a way to measure skin thickness.
Must have worsening skin or muscle and joint disease, such as new areas of skin involvement or **tendon friction rubs (TFR)**, with either a **Health Assessment Questionnaire Disability Index (HAQ-DI)** score greater than 1.0 or high levels of **erythrocyte sedimentation rate (ESR)** or **C-reactive protein (CRP)**, which are markers of inflammation.
Must have **interstitial lung disease (ILD)** with specific lung function test results: **forced vital capacity (FVC)** between 50% and less than 80% of what is predicted, or **lung diffusion testing (DLCO)** (corrected for hemoglobin) between 45% and 75%, or more than 10% lung involvement on a high-resolution CT scan. Alternatively, must have progressive ILD, which means worsening lung fibrosis.
Must have tried and not responded to at least two established systemic immunosuppressive treatments, such as methotrexate, mycophenolate mofetil, azathioprine, rituximab, tocilizumab, intravenous immunoglobulin (IVIG), or cyclophosphamide, each for at least 3 months. Can continue taking oral corticosteroids (up to 10 mg/day of prednisone or equivalent) and nonsteroidal anti-inflammatory drugs (NSAIDs) if the dose has been stable for 2 weeks before and including the start of the study.
Must have provided written informed consent to participate in the study.

Who cannot join the trial?

3 criteria

Patients who do not have early diffuse cutaneous systemic sclerosis cannot participate. This is a specific type of a condition that affects the skin and other organs.
Patients who are not within the specified age range cannot participate. The study is for certain age groups only.
Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care.

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Responsive
Stichting Radboud University Medical Center
Nijmegen, The Netherlands

Trial locations

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Investigated drugs

T-Guard is a medication being studied for its potential to treat early diffuse cutaneous systemic sclerosis, a condition that affects the skin and internal organs. The main goal of the trial is to assess the safety of T-Guard in patients with this condition. T-Guard is designed to target and eliminate specific immune cells that are thought to contribute to the disease, potentially reducing symptoms and improving patient outcomes.

GRISNILIMAB SETARITOX

What is already known about the treatment

T-Guard – T-Guard is administered intravenously and is currently being evaluated in clinical trials for its safety in treating early diffuse cutaneous systemic sclerosis. This medication is not yet widely recognized in medical literature as it is still under investigation. The main therapeutic indication for T-Guard is to target and eliminate autoreactive T cells, which are believed to contribute to the progression of systemic sclerosis. At the molecular level, T-Guard works by selectively depleting these harmful T cells, potentially reducing inflammation and tissue damage. It is classified pharmacologically as an immunomodulatory agent.

Investigated diseases

Diffuse Cutaneous Systemic Sclerosis – This is a rare autoimmune disease characterized by the hardening and tightening of the skin and connective tissues. It primarily affects the skin but can also involve internal organs such as the lungs, heart, and kidneys. The disease progresses with the thickening of the skin, starting from the fingers and hands, and can spread to the arms, face, and trunk. Patients may experience joint pain, stiffness, and swelling, along with digestive issues due to gastrointestinal involvement. Over time, the disease can lead to reduced mobility and function of affected areas. The exact cause is unknown, but it involves an overactive immune response leading to excessive collagen production.