Study of the Efficacy of Nintedanib+Tocilizumab in Patients With Systemic Sclerosis and Interstit… (NCT06297096) | Clinical Trial Compass
RecruitingPhase 3
Study of the Efficacy of Nintedanib+Tocilizumab in Patients With Systemic Sclerosis and Interstitial Lung Disease
Poland86 participantsStarted 2025-07-01
Plain-language summary
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.
Who can participate
Age range18 Years – 74 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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 Rheumatism) - EULAR, meeting the criteria of active disease \[patients with limited and diffused SSc)\] and with an overall disease duration of less than or equal to (≤ 72 months).
✓. 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.
Exclusion criteria
✕. Patients not fully capable of giving informed consent.
What they're measuring
1
The decrease in forced vital capacity (FVC) of the lungs
Timeframe: 56 weeks
Trial details
NCT IDNCT06297096
SponsorNational Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
✕. 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.