Study of the Efficacy of Nintedanib+Tocilizumab in Patients With Systemic Sclerosis and Interstitial Lung Disease

Sponsor
National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
Study ID
NCT06297096
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 74 Years
Healthy Volunteers
Not accepted

Interventions

  • Tocilizumab — DRUG
    Tocilizumab 162 mg s.c./week
  • Nintedanib — DRUG
    Nintedanib - established doses of nintedanib for adults in the treatment of ILD, also SSc-ILD: 2 x 150 mg daily, in the event of e.g. increased liver enzyme levels, poorer treatment tolerance (e.g. diarrhea), the dose can be reduced to 2 x 100 mg
  • Standard therapy — DRUG
    mycophenolate mofetil stable dose from 1000 - 3000 mg daily tablet 500 mg or 250 mg regardless of the preparation (Mycofit, CellCept, Mycophenolate mofetil, Myfenax) or methotrexate 10-25 mg/week orally or subcutaneously as above, regardless of the preparation

Study Details

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.

Key Dates

Start date
Jul 1, 2025
Status verified
Jan 2026
Primary completion
Dec 30, 2027
Completion
Mar 30, 2028

Study Design

Enrollment
86 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: combined therapy Nintedanib + Tocilizumab with or without standard treatment + extended diagnostics
    tocilizumab pre-filled syringe 162 mg subcutaneously once a week nintedanib tablets 150 mg twice a day or 2 x 100 mg a day
  • Active Comparator: standard treatment (reference group) + extended diagnostics
    mycophenolate mofetil stable dose from 1000 - 3000 mg daily tablet 500 mg or 250 mg regardless of the preparation (Mycofit, CellCept, Mycophenolate mofetil, Myfenax) or methotrexate 10-25 mg/week orally or subcutaneously as above, regardless of the preparation

Primary Outcome Measure

The decrease in forced vital capacity (FVC) of the lungs [ Time Frame: 56 weeks ]

Central Contacts

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