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Comparison of treatment efficacy in the patients with Systemic sclerOsis: dapagliFlozin vs. Tocilizumab – a randomized head to head study
EU CTIS ID: 2025-523714-92-00
What this study is testing
Comparison of the efficacy of dapagliflozin and tocilizumab in the treatment of patients with systemic sclerosis after 12 months of therapy.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age > 18 years at the screening visit (W1).
- Diagnosis of Systemic Sclerosis according to the 2023 ACR/EULAR criteria, confirmed by clinician.
- Form of the disease: diffuse cutaneous systemic sclerosis (dcSSc), with involvement of the skin proximal to the metacarpophalangeal joints and/or the trunk.
- Disease duration: ≤ 5 years from the first non-Raynaud’s symptom (the aim is to include patients in the early or intermediate fibrotic phase, when modification of the disease course is still possible).
- Active skin fibrosis, defined as a Modified Rodnan Skin Score (mRSS) of 15–40 points at the screening visit (a range of 15–40 corresponds to the active fibrotic phase, in which the likelihood of reversibility of fibrosis-related changes is the highest).
- Stable systemic sclerosis pharmacotherapy (if applicable) for ≥4 weeks prior to inclusion in the clinical trial (e.g., mycophenolate mofetil, methotrexate, phosphodiesterase-5 inhibitors).
You likely can't join if
- Absolute contraindications to the use of any of the investigational medicinal product.
- Clinically significant uncontrolled diabetes, i.e., a condition in which diabetes was diagnosed prior to the screening visit and the most recent HbA1c result (not older than 6 months) is greater than 10%.
- Active malignancy or history of malignancy within < 5 years before investigational medicinal product administration.
- Any concomitant disease requiring surgery within < 7 days before investigational medicinal product administration.
- Any other concomitant or prior disease that, in the investigator’s opinion, constitutes a contraindication to the patient’s participation in the clinical trial.
- Inability or willingness to comply with the study protocol requirements or reasonable suspicion that the participant will not comply with the study protocol recommendations.
See the full eligibility criteria
Who can join
- Age > 18 years at the screening visit (W1).
- Diagnosis of Systemic Sclerosis according to the 2023 ACR/EULAR criteria, confirmed by clinician.
- Form of the disease: diffuse cutaneous systemic sclerosis (dcSSc), with involvement of the skin proximal to the metacarpophalangeal joints and/or the trunk.
- Disease duration: ≤ 5 years from the first non-Raynaud’s symptom (the aim is to include patients in the early or intermediate fibrotic phase, when modification of the disease course is still possible).
- Active skin fibrosis, defined as a Modified Rodnan Skin Score (mRSS) of 15–40 points at the screening visit (a range of 15–40 corresponds to the active fibrotic phase, in which the likelihood of reversibility of fibrosis-related changes is the highest).
- Stable systemic sclerosis pharmacotherapy (if applicable) for ≥4 weeks prior to inclusion in the clinical trial (e.g., mycophenolate mofetil, methotrexate, phosphodiesterase-5 inhibitors).
- Informed consent to participate in the study.
- In laboratory tests performed during the screening period: - Absolute neutrophil count (ANC) ≥ 2 × 10⁹/L; - Platelet count ≥ 100 × 10³/μL; - Hemoglobin ≥ 8.0 g/dL; - Negative laboratory test results for QuantiFERON, HBsAg, anti-HIV, and anti-HCV.
- Consent to use effective contraception by women of childbearing potential and men and their partners of reproductive potential during the time period of taking the investigational medicinal products and for at least 3 months after the last dose of the investigational medicinal product.
What rules you out
- Absolute contraindications to the use of any of the investigational medicinal product.
- Clinically significant uncontrolled diabetes, i.e., a condition in which diabetes was diagnosed prior to the screening visit and the most recent HbA1c result (not older than 6 months) is greater than 10%.
- Active malignancy or history of malignancy within < 5 years before investigational medicinal product administration.
- Any concomitant disease requiring surgery within < 7 days before investigational medicinal product administration.
- Any other concomitant or prior disease that, in the investigator’s opinion, constitutes a contraindication to the patient’s participation in the clinical trial.
- Inability or willingness to comply with the study protocol requirements or reasonable suspicion that the participant will not comply with the study protocol recommendations.
- Confirmed history of alcohol or substance abuse, either currently or within 12 months prior to administration of the investigational medicinal product. Alcohol abuse is defined as more than 14 units of alcohol per week.
- Participation in another clinical trial or research experiment within 4 weeks prior to the screening visit or within less than 5 half-lives of the investigational medicinal product, depending on which of these periods is longer.
- Pregnancy or lactation.
- Individuals lacking legal capacity.
- Individuals lacking the capacity to independently provide informed consent for participation in the study.
- Known hypersensitivity to any ingredient of the investigational medicinal product.
- Other medical condition that, in the investigator's opinion, could expose the patient to an increased risk of health deterioration during participation in the study.
- A patient condition that prevents performing diagnostic tests such as HRCT, MRI, ECHO, and/or ECG, e.g., the presence of certain types of implants, contraindications to contrast agents, claustrophobia, or other conditions that contraindicate the examination.
- Clinically significant, uncontrolled respiratory disease.
- History of intestinal ulcers or diverticulitis, unless in the investigator’s opinion the patient’s current condition allows inclusion in the study.
- Hepatic disfunction associated with out of range laboratory results: ALT ≥ 2x ULN and/or AST ≥ 2 x ULN, and/or total bilirubin ≥ 1,5 ULN.
- Renal impairment (eGFR < 30 ml/min/1.73 m²) or ongoing use of renal replacement therapy, i.e., haemodialysis or peritoneal dialysis.
- Heart failure class III or IV according to the New York Heart Association (NYHA) classification.
- History of myocardial infarction or stroke within 6 months before investigational medicinal product administration.
- Systolic blood pressure >180 mm Hg and/or diastolic blood pressure >110 mm Hg at the screening visit (Week 1).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.