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Tests treatment safety and results for Systemic Sclerosis
Official title Study of the Efficacy of Nintedanib+Tocilizumab in Patients With Systemic Sclerosis and Interstitial Lung Disease
ClinicalTrials.gov ID: NCT06297096
What this study is testing
What is Tocilizumab?
Tocilizumab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for systemic sclerosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study includes adult patients with systemic sclerosis (SSc) with interstitial lung disease (ILD) to evaluate the efficacy and safety of nintedanib plus tocilizumab combination therapy compared to standard therapy (methotrexate, mycophenolate mofetil) for 56 weeks.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 74
You may be able to join if
- Men or women aged 18-74 at the date of signing the informed consent.
- Written informed consent in accordance with the International Harmonization Guidelines Harmonized Tripartite: Guidelines for Good Clinical Practice...
- Documented diagnosis of systemic sclerosis according to the criteria of the American College of Rheumatology (ACR) and The European Alliance of...
- Patients with interstitial lung disease (ILD) confirmed by HRCT (min. 10% lung involvement).
- Evaluation of skin induration with the modified Rodnan skin score (mRSS) from 10 to 45 units inclusive.
You likely can't join if
- Patients not fully capable of giving informed consent.
- Pregnant or breastfeeding women.
- Major surgery within 8 weeks before screening (W0A).
- Rheumatic disease other than systemic sclerosis (systemic lupus erythematosus, rheumatoid arthritis, mixed connective tissue disease). Diagnosis of...
- Active diverticulitis and severe enteritis.
- Untreated lipid disorders (Initiation of treatment and modification of the lipid profile enable re-screening for examination after 8 weeks from the...
See the full eligibility criteria
Who can join
- Men or women aged 18-74 at the date of signing the informed consent.
- Written informed consent in accordance with the International Harmonization Guidelines Harmonized Tripartite: Guidelines for Good Clinical Practice (ICH-GCP) and local regulations signed before any study procedure.
- Documented diagnosis of systemic sclerosis according to the criteria of the American College of Rheumatology (ACR) and The European Alliance of Associations for Rheumatology (former name - European League Against...
- Patients with interstitial lung disease (ILD) confirmed by HRCT (min. 10% lung involvement).
- Evaluation of skin induration with the modified Rodnan skin score (mRSS) from 10 to 45 units inclusive.
- Patients treated with conventional drugs such as mycophenolate mofetil, methotrexate; should be on stable doses for ≥ 8 weeks before and including the screening visit (W0).
- Patients may be treated with standard therapy, but no new therapy or withdrawal of therapy within 8 weeks before the first screening visit (W0).
- Patients taking oral glucocorticosteroids (GCS) should be on a stable dose of ≤ 10 mg/day prednisone or equivalent for at least 8 weeks before the baseline visit.
- Patients of childbearing potential should agree to abstain from sexual activity or use a highly effective method of contraception throughout the study and for at least 3 months after the last dose of medicinal products.
What rules you out
- Patients not fully capable of giving informed consent.
- Pregnant or breastfeeding women.
- Major surgery within 8 weeks before screening (W0A).
- Rheumatic disease other than systemic sclerosis (systemic lupus erythematosus, rheumatoid arthritis, mixed connective tissue disease). Diagnosis of secondary Sjögren's syndrome is acceptable.
- Active diverticulitis and severe enteritis.
- Untreated lipid disorders (Initiation of treatment and modification of the lipid profile enable re-screening for examination after 8 weeks from the start of hypolipidemic treatment).
- Immunization with a live or attenuated vaccine within 4 weeks before scheduled treatment.
- Known hypersensitivity to human, humanized or murine monoclonal antibodies and hypersensitivity to peanut, soya.
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels greater than 1.5 times the upper limit of normal (ULN). If normalized, the patient may be considered for re-screening.
- Bilirubin \>1.5 x ULN.
- Creatinine clearance \<30 ml/min.
- Significant pulmonary hypertension (PH).
- Airway obstruction (forced expiratory volume before bronchodilation in 1 second (FEV1)/FVC \<0.7) and other clinically significant pulmonary abnormalities.
- Cardiovascular diseases with heart failure NYHA III/IV.
- More than 4 digital ulcers or a history of severe digital necrosis requiring hospitalization or severe other digital ulcers.
- Bleeding risk (such as bleeding tendency, fibrinolysis, full dose of anticoagulants, high dose of antiplatelet therapy, history of central nervous system (CNS) bleeding events in the last year. (INR) \>2, prothrombin...
- History of stroke, or myocardial infarction within 6 months before screening.
- Prior treatment with pirfenidone or nintedanib if a minimum of 6 months had not been completed before enrolling the patient in the NINTOC-TU study.
- Plasmapheresis and/or plasma exchange within the last 12 weeks before screening and use of immunoglobulins within the last 12 weeks and treatment with tocilizumab, treatments targeting B cell depletion, biologics (e.g...
- Treatment with prednisone \>10 mg/day, azathioprine, hydroxychloroquine, colchicine, D-penicillamine, sulfasalazine if within 8 weeks before W0. Cyclophosphamide within \< 8 weeks of randomization visit (W 1). Rituximab...
- Unstable (fluctuating) background therapy with mycophenolate mofetil or methotrexate in the last 8 weeks.
- Patients with chronic liver disease (Child-Pugh A, B, C hepatic impairment).
- Active or significant history of infection, including treatment with intravenous antibiotics within the last 4 weeks or oral antibiotics within 2 weeks before screening. Including active confirmed tuberculosis or latent...
- A positive result of the SARS-CoV-2 PCR test during the "0" visit is an exclusion criterion, while a history of infection more than 4 weeks before the screening tests and confirmed by a negative SARS-CoV-2 PCR test is...
- Active or history of malignancy, except for excised/cured local basal cell or squamous cell carcinoma of the skin or cervical carcinoma in situ.
- Active or past drug or alcohol abuse.
- The inability to understand and comply with the requirements of the protocol (lack of compliance) excludes from participation in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Warsaw, Masovian Voivodeship, Poland
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 years to 74 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Warsaw, Masovian Voivodeship, Poland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.