Comparing Dapagliflozin and Tocilizumab for Treating Patients with Systemic Sclerosis

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What is this study about?

This study examines systemic sclerosis, a disease that causes hardening and tightening of the skin and can affect internal organs. The condition occurs when the body produces too much connective tissue, leading to thickening and stiffness of the skin, particularly on the hands, arms, and face, and potentially affecting the heart, lungs, and kidneys. The study will compare two different treatments: dapagliflozin, given as tablets taken by mouth, and tocilizumab, given as an infusion into a vein. Some participants will receive placebo instead of dapagliflozin. Sodium chloride solution will be used during the infusion process. The purpose of this study is to compare how well dapagliflozin works compared to tocilizumab in treating patients with systemic sclerosis after 12 months of treatment.

Participants in this study will receive their assigned treatment for 12 months. During this time, they will undergo various examinations to monitor how the disease is affecting their body. These examinations will include measurements of skin thickness, imaging tests such as magnetic resonance imaging to look at the heart and computed tomography to examine the lungs, tests to check kidney function, and blood tests to measure inflammation markers. Participants will also have a procedure called capillaroscopy, which looks at tiny blood vessels in the fingernails, and will complete questionnaires about their quality of life and emotional well-being.

Throughout the study, doctors will carefully monitor participants for any side effects or unwanted reactions to the treatments. The study will measure changes in disease severity using a scoring system that assesses skin thickness in different areas of the body. Additional measurements will evaluate how the disease affects various organs including the heart, lungs, and kidneys, as well as the overall impact on daily life and mental health. The entire treatment period will last 12 months, during which participants will attend regular visits for examinations and assessments.

1 Initial screening and baseline assessments

At the first visit, your current health status will be assessed to confirm eligibility for the study.

A physical examination will be performed, including assessment of skin thickness using the Modified Rodnan Skin Score, which measures the extent of skin involvement in different body areas on a scale from 0 to 51 points.

Blood samples will be collected to check your blood cell counts, including neutrophils (a type of white blood cell), platelets (cells responsible for blood clotting), and hemoglobin (a protein that carries oxygen in red blood cells).

Laboratory tests will be conducted to exclude certain infections, including tests for tuberculosis, hepatitis B, HIV, and hepatitis C.

If you are currently taking medications for systemic sclerosis, these must have been at a stable dose for at least 4 weeks before entering the study.

2 Assignment to treatment group

You will be randomly assigned to one of two treatment groups. This means that neither you nor the study doctor will choose which treatment you receive.

One group will receive dapagliflozin tablets along with placebo infusions (infusions without active medication).

The other group will receive tocilizumab infusions along with placebo tablets (tablets without active medication).

This design ensures that all participants receive both tablets and infusions, maintaining consistency across groups.

3 Treatment period with dapagliflozin or tocilizumab

The treatment will last for 12 months.

If you are assigned to the dapagliflozin group, you will take 10 mg tablets by mouth daily. You will also receive intravenous infusions (medication given directly into a vein) of placebo.

If you are assigned to the tocilizumab group, you will receive tocilizumab infusions administered intravenously. The infusions will be prepared using RoActemra concentrate diluted in sodium chloride solution. You will also take placebo tablets by mouth daily.

The infusions will be given at a medical facility and will take some time to complete, as the medication is administered slowly through a vein.

4 Regular monitoring visits during treatment

Throughout the 12-month treatment period, you will attend regular follow-up visits.

At these visits, the study doctor will assess your skin thickness using the Modified Rodnan Skin Score to monitor changes in skin involvement.

A capillaroscopy examination will be performed, which is a non-invasive procedure that uses a special microscope to examine the tiny blood vessels in your nail beds. This helps assess blood vessel changes associated with systemic sclerosis.

Blood samples will be collected to measure levels of inflammatory markers (substances in the blood that indicate inflammation) and to monitor your kidney function, including eGFR (estimated glomerular filtration rate, which measures how well your kidneys filter blood) and albuminuria (presence of protein in urine, which can indicate kidney problems).

You will be asked to complete several questionnaires about your quality of life, stress levels, general health, depression symptoms, and anxiety symptoms. These questionnaires help assess how the disease and treatment affect your daily life and emotional well-being.

Any side effects or health changes you experience will be recorded and assessed for safety monitoring.

5 Imaging studies during treatment

During the study, you will undergo cardiac magnetic resonance imaging (heart MRI) and echocardiography (ultrasound of the heart) to evaluate your heart structure and function.

A high-resolution computed tomography (HRCT) scan of your chest will be performed to assess your lung tissue and detect any changes in lung structure.

These imaging studies provide detailed information about how systemic sclerosis affects your heart and lungs, and whether the treatment has any impact on these organs.

6 Final assessment at 12 months

After completing 12 months of treatment, you will have a final comprehensive assessment.

All the evaluations performed at earlier visits will be repeated, including skin thickness measurement, capillaroscopy, blood tests, imaging studies, and questionnaires.

The results from this final visit will be compared to your initial assessments to determine how effective the treatment has been in managing your systemic sclerosis.

The study doctor will review all safety information, including any side effects you experienced during the study.

Who Can Join the Study?

You must be older than 18 years of age
You must have a confirmed diagnosis of Systemic Sclerosis, which is a disease that causes hardening and tightening of the skin and connective tissues, confirmed according to specific medical criteria from 2023
You must have the diffuse cutaneous form of the disease, meaning the skin thickening affects areas beyond the fingers, such as the arms, legs, or trunk of the body
Your disease must have started no more than 5 years ago, counting from the first symptom that was not Raynaud’s phenomenon (Raynaud’s is when fingers or toes change color due to cold or stress)
You must have active skin thickening with a score between 15 and 40 points on the Modified Rodnan Skin Score, which is a measurement system doctors use to assess how much of your skin is affected and how thick it is
If you are taking medications for systemic sclerosis, your treatment must have been stable for at least 4 weeks before joining the study
You must agree to participate in the study by signing an informed consent form
Your blood tests must show: sufficient levels of neutrophils (a type of white blood cell that fights infection), at least 2 × 10⁹ per liter; enough platelets (cells that help blood clot), at least 100 × 10³ per microliter; adequate hemoglobin (the protein in red blood cells that carries oxygen), at least 8.0 grams per deciliter; and negative results for tuberculosis, hepatitis B, HIV, and hepatitis C infections
If you are a woman who can become pregnant or a man whose partner can become pregnant, you must agree to use effective birth control during the study and for at least 3 months after receiving the last dose of study medication

Who Cannot Join the Study?

Pregnancy or breastfeeding: Women who are pregnant, planning to become pregnant, or breastfeeding cannot participate in this study.
Severe kidney disease: Patients with serious problems with kidney function, meaning the organs that filter waste from your blood, cannot join the study.
Severe liver disease: Patients with serious problems with liver function, the organ that helps clean your blood and digest food, are not eligible.
Active infections: Patients who currently have a serious infection, such as tuberculosis or other infections that require treatment, cannot participate.
History of cancer: Patients who have had cancer within the last 5 years, except for certain skin cancers that have been successfully treated, are excluded.
Heart failure: Patients with severe heart failure, meaning the heart cannot pump blood effectively enough, cannot join the study.
Allergies to study medications: Patients who have had allergic reactions to dapagliflozin or tocilizumab, the medications being tested, or any of their ingredients are not eligible.
Type 1 diabetes: Patients with type 1 diabetes, a condition where the body does not produce insulin, cannot participate.
Recent major surgery: Patients who have had major surgery within the last 3 months are excluded.
Other autoimmune diseases: Patients with other serious autoimmune diseases, conditions where the body’s defense system attacks its own tissues, that are not well controlled may not be eligible.
Use of certain medications: Patients taking specific medications that could interfere with the study drugs may be excluded.
Inability to give consent: Patients who cannot understand or sign the consent form to participate in the study are not eligible.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Pvptbxfkc Idajlbps Mvvenrna Mkxzukborxje Sfyfl Wispupslqslm I Asbsexijaxkbo	Warsaw	Poland

Trial status

Country	Status	Recruitment Start
Poland	Not yet recruiting	01.03.2026

Trial locations

Investigated drugs:

Dapagliflozin is a medication that was originally developed to help control blood sugar levels in people with diabetes. It works by helping the kidneys remove excess sugar from the body through urine. In this study, researchers want to see if it can help treat systemic sclerosis, which is a condition that causes hardening and tightening of the skin and connective tissues.

Tocilizumab is a medication that affects the immune system by blocking a protein called interleukin-6, which causes inflammation in the body. It is used to treat various conditions where the immune system attacks the body’s own tissues. In this study, it is being tested to see how well it works for treating systemic sclerosis.

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. It can also affect internal organs including the lungs, heart, kidneys, and digestive system. Blood vessels may become damaged, leading to poor circulation in the fingers and toes. The disease progresses differently in each person, with some experiencing mainly skin changes while others develop significant organ involvement. Systemic sclerosis is classified as a rare disease and its course can vary from slow progression over many years to more rapid advancement.

Trial ID:

2025-523714-92-00

Protocol code:

2025-ABM-CMKP-01

Trial Phase:

Therapeutic exploratory (Phase II)

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Comparing Dapagliflozin and Tocilizumab for Treating Patients with Systemic Sclerosis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?