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

NCT06297096 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2026-04-08

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Tocilizumab

Tocilizumab 162 mg s.c./week

DRUG

Nintedanib

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

DRUG

Standard therapy

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

Sponsors & Collaborators

  • Medical Research Agency, Poland

    collaborator OTHER_GOV

  • National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland

    lead NETWORK

Principal Investigators

  • Maria Maślińska, PhD, MD · National Institute of Geriatrics,Rheumatology and Rehabilitation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2027-12-30
Completion
2028-03-30

Countries

  • Poland

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06297096 on ClinicalTrials.gov