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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Double Blind, Randomised, Placebo-controlled Trial Evaluating Efficacy and Safety of Oral Nintedanib Treatment for at Least 52 Weeks in Patients With Systemic Sclerosis

Brief 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.

Detailed Summary:
Sponsor: Boehringer Ingelheim

Current Primary Outcome: Annual rate of decline in FVC in mL [ Time Frame: 52 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Time to all-cause mortality [ Time Frame: 52 weeks ]
  • Absolute change from baseline in FACIT dyspnoea score [ Time Frame: 52 weeks ]
  • Absolute change from baseline in the mRSS [ Time Frame: 52 weeks ]
  • Absolute change from baseline in SGRQ total score [ Time Frame: 52 weeks ]
  • Annual rate of decline in FVC in percent predicted [ Time Frame: 52 weeks ]
  • Absolute change from baseline in FVC in mL [ Time Frame: 52 weeks ]
  • Relative change from baseline (%) of mRSS [ Time Frame: 52 weeks ]
  • Absolute change from baseline in DLCO in percent predicted [ Time Frame: 52 weeks ]
  • Absolute change from baseline in digital ulcer net burden (defined as the number of new digital ulcers (DUs) plus the number of DUs that have been verified at any earlier assessment during the trial) [ Time Frame: 52 weeks ]
  • Absolute change from baseline in SHAQ total score [ Time Frame: 52 weeks ]


Original Secondary Outcome: Same as current

Information By: Boehringer Ingelheim

Dates:
Date Received: October 8, 2015
Date Started: November 12, 2015
Date Completion: December 28, 2018
Last Updated: May 16, 2017
Last Verified: May 2017