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A Trial to Compare Nintedanib With Placebo for Patients With Scleroderma Related Lung Fibrosis

NCT02597933 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 580

Last updated 2019-12-13

Study results available
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Summary

Systemic Sclerosis (SSc) is a devastating disease of unknown etiology. Patients suffer from multiple organ fibrosis whereas lung fibrosis (interstitial lung disease, ILD) is one of the main driver for mortality. There is preclinical evidence for efficacy of nintedanib in SSc and associated ILD (SSc-ILD) and the anti-fibrotic efficacy of nintedanib was proven in idiopathic pulmonary fibrosis patients, who are presenting a similar pattern regarding lung fibrosis. Hence it is the purpose of the trial to confirm the efficacy and safety of nintedanib 150 mg bid in treating patients with SSc-ILD, compared with placebo. The trial will be conducted as a double blind, randomised, placebo-controlled trial with primary efficacy evaluation at week 52 and placebo-controlled treatment until last patient out (up to a maximum of 100 weeks). Respiratory function is globally accepted for assessment of treatment effects in patients with lung fibrosis. The chosen endpoint (Forced Vital Capacity (FVC) decline) is easy to obtain and is part of the usual examinations done in patients with SSc-ILD.

Conditions

  • Scleroderma, Systemic

Interventions

DRUG

Nintedanib

DRUG

Placebo

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-12
Primary Completion
2018-10-31
Completion
2018-11-28

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • Chile
  • China
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • India
  • Ireland
  • Israel
  • Italy
  • Japan
  • Malaysia
  • Mexico
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Spain
  • Sweden
  • Switzerland
  • Thailand
  • United Kingdom

Study Locations

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Entities

Drugs
Companies

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 NCT02597933 on ClinicalTrials.gov