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

Completed · Phase 3 · Has a placebo group

Conditions studied: Scleroderma, Systemic

In brief

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.

Key facts

Study ID

NCT02597933

Run by

Boehringer Ingelheim

People needed

580

Starts

2015-11-12

Expected to finish

2018-11-28

Last updated by the study team

2019-12-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age >= 18 years
• 2013 American College of Rheumatology (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 High Resolution Computer Tomography (HRCT); Extent of fibrotic disease in the lung >= 10%
• FVC >= 40% of predicted normal
• Carbon Monoxide Diffusion Capacity (DLCO) 30% to 89% of predicted normal

You may not qualify if…

• Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) >1.5 x ULN
• Bilirubin >1.5 x ULN
• Creatinine clearance <30 mL/min
• Airway obstruction (pre-bronchodilator Forced Expiratory Volume in 1 second (FEV1)/FVC <0.7)
• Other clinically significant pulmonary abnormalities
• Significant Pulmonary Hypertension (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, colchicine, D-penicillamine, sulfasalazine, cyclophosphamide, rituximab, tocilizumab, abatacept, leflunomide, tacrolimus, newer anti-arthritic treatments like tofacitinib and cyclosporine 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)

Where it is running

• University of California Los Angeles — Los Angeles, California, United States
• University of California Davis — Sacramento, California, United States
• University of California San Francisco — San Francisco, California, United States
• Stanford University Medical Center — Stanford, California, United States
• University of Colorado Denver — Aurora, Colorado, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Georgetown University — Washington D.C., District of Columbia, United States
• University of Florida College of Medicine — Jacksonville, Florida, United States
• University of Miami — Miami, Florida, United States
• The Emory Clinic — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• University of Iowa — Iowa City, Iowa, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• University of Louisville — Louisville, Kentucky, United States
• Tulane University Hospital and Clinic — New Orleans, Louisiana, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Boston Medical Center — Boston, Massachusetts, United States
• University of Michigan Health System — Ann Arbor, Michigan, United States
• University of Minnesota Masonic Cancer Center — Minneapolis, Minnesota, United States
• Mayo Clinic-Rochester — Rochester, Minnesota, United States
• The Lung Research Center, LLC — Chesterfield, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Hospital for Special Surgery — New York, New York, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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