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)
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)
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.
Inclusion criteria:
Exclusion criteria:
New York, New York 10032, United States
Ciudad Autonoma Buenos Aires, C1046AAQ, Argentina
Aichi, Seto, 489-8642, Japan
Fukuoka, Kurume, 830-0011, Japan
Hyogo, Himeji, 670-8520, Japan
Iwate, Morioka, 020-8505, Japan
Kanagawa, Kawasaki, 216-8511, Japan
Kanagawa, Sagamihara, 252-0375, Japan
Kanagawa, Yokohama, 236-0051, Japan
Kyoto, Kyoto, 606-8507, Japan
Nagasaki, Nagasaki, 852-8501, Japan
Osaka, Osakasayama, 589-8511, Japan
Osaka, Sakai, 591-8555, Japan
Osaka, Takatsuki, 569-8686, Japan
Shizuoka, Hamamatsu, 431-3192, Japan
Tokushima, Tokushima, 770-8503, Japan
Tokyo, Bunkyo-Ku, 113-8431, Japan
Tokyo, Bunkyo-Ku, 113-8603, Japan
Tokyo, Ota-ku, 143-8541, Japan
Muang, 40002, Thailand