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

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ClinicalTrials.gov Identifier: NCT02597933
Recruitment Status : Completed
First Posted : November 5, 2015
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE October 8, 2015
First Posted Date  ICMJE November 5, 2015
Last Update Posted Date December 7, 2018
Actual Study Start Date  ICMJE November 12, 2015
Actual Primary Completion Date October 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 4, 2015)
Annual rate of decline in FVC in mL [ Time Frame: 52 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02597933 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 4, 2015)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial to Compare Nintedanib With Placebo for Patients With Scleroderma Related Lung Fibrosis
Official Title  ICMJE 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 Associated Interstitial Lung Disease (SSc-ILD)
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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Scleroderma, Systemic
Intervention  ICMJE
  • Drug: Nintedanib
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Nintedanib
    patient receives capsules containing nintedanib twice a day
    Intervention: Drug: Nintedanib
  • Placebo Comparator: Placebo
    patient receives capsules identical to those containing active drug
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 16, 2018)
580
Original Estimated Enrollment  ICMJE
 (submitted: November 4, 2015)
520
Actual Study Completion Date  ICMJE November 28, 2018
Actual Primary Completion Date October 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  • Age >= 18 years
  • 2013 ACR / EULAR classification criteria for SSc fulfilled
  • SSc disease onset (defined by first non-Raynaud symptom) within 7 years
  • SSc related Interstitial Lung Disease confirmed by HRCT; Extent of fibrotic disease in the lung >= 10%
  • FVC >= 40% of predicted normal
  • DLCO 30% to 89% of predicted normal

Exclusion criteria:

  • AST, ALT >1.5 x ULN
  • Bilirubin >1.5 x ULN
  • Creatinine clearance <30 mL/min
  • Airway obstruction (pre-bronchodilator FEV1/FVC <0.7)
  • Other clinically significant pulmonary abnormalities
  • Significant PH
  • Cardiovascular diseases
  • More than 3 digital fingertip ulcers or a history of severe digital necrosis requiring hospitalization or severe other ulcers
  • Bleeding risk (such as predisposition to bleeding, fibrinolysis, full-dose anticoagulation, high dose antiplatelet therapy, history of hemorrhagic central nervous system (CNS) event within last year
  • international normalised ratio (INR) >2, prolongation of prothrombin time (PT) and partial thromboplastin time (PTT) by >1.5 x ULN)
  • History of thrombotic event within last year
  • Clinical signs of malabsorption or needing parenteral nutrition
  • Previous treatment with nintedanib or pirfenidone
  • Treatment with prednisone >10 mg/day, azathioprine, hydroxychloroquine, colchizine, D-penicillamine, sulfasalazine, cyclophosphamide, rituximab, tocilizumab, abatacept, leflunomide, tacrolimus, newer anti-arthritic treatments like tofacitinib and ciclosporine A, potassium para-aminobenzoate
  • Unstable background therapy with either mycophenolate mofetil or methotrexate
  • Previous or planned hematopoietic stem cell transplantation
  • Patients with underlying chronic liver disease (Child Pugh A, B, C hepatic impairment)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE 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,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02597933
Other Study ID Numbers  ICMJE 1199.214
2015-000392-28 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP