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

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Shissamgy Rfvuulm Ulscgbjyxv Mydjkyx Cxikko	Nijmegen	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	30.01.2025

Trial locations

Investigated drugs:

GRISNILIMAB SETARITOX

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.

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.

Trial ID:

2024-517283-28-00

Protocol code:

PHIL_TG01

Trial Phase:

Human Pharmacology (Phase I) – Other

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?