A Double Blind, Randomized, Placebo-controlled Trial Evaluating the Efficacy and Safety of BI 1015550 Over at Least 52 Weeks in Patients With Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs)
A Double Blind, Randomized, Placebo-controlled Trial Evaluating the Efficacy and Safety of BI 1015550 Over at Least 52 Weeks in Patients With Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs)
This study is open to adults with Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs). People who have a form of PF-ILD other than Idiopathic Pulmonary Fibrosis (IPF) can join the study. If they already take nintedanib, they can continue treatment throughout the study.
The purpose of this study is to find out whether a medicine called BI 1015550 helps people with PF-ILD. Participants are put into 3 groups randomly, which means by chance. Participants in 2 groups take different doses of BI 1015550 as tablets twice a day. Participants in the placebo group take placebo tablets twice a day. Placebo tablets look like BI 1015550 tablets but do not contain any medicine.
Participants are in the study for up to two and a half years. During the first year, they visit the study site 10 times. Afterwards, they visit the study site every 3 months. The doctors regularly test participants' lung function. The results of the lung function tests are compared between the groups. The doctors also regularly check participants' health and take note of any unwanted effects.
Inclusion criteria
Patients ≥18 years old at the time of signed informed consent.
Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
Diagnosis of progressive fibrosing ILD other than IPF (physician confirmed).
Patients may be either:
Forced Vital Capacity (FVC) ≥45% of predicted normal at Visit 1.
DLCO ≥25% of predicted normal corrected for hemoglobin (Hb) at Visit 1.
Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control. WOCBP taking oral contraceptives (OCs) also have to use one barrier method
Patients treated with permitted immunosuppressive agents (other than corticosteroids) for an underlying systemic disease (e.g. Methotrexate (MTX), Azathioprine (AZA)) need to be on a stable treatment for at least 12 weeks prior to Visit 1 and during the screening period.
Exclusion criteria
Further exclusion criteria apply.
New York, New York 10032, United States
Nashville, Tennessee 37204, United States
C.a.b.a, 1056, Argentina
CABA, C1060ABN, Argentina
CABA, C1199ABB, Argentina
Capital Federal, 1425, Argentina
Ciudad Autonoma Buenos Aires, C1046AAQ, Argentina
Camperdown, Sydney, New South Wales 2050, Australia
Belo Horizonte,Minas Gerais, 31270901, Brazil
Porto Alegre - RS, CEP 91350-, Brazil
Providencia, Santiago de Chile, 7500000, Chile
Wenxzhou, 325000, China
Essen, 45239, Germany
Crete, 71500, Greece
Beer Yaakov, 7033001, Israel
Torrette Di Ancona (Ancona), 60126, Italy
Aichi, Seto, 489-8642, Japan
Aichi, Toyoake, 470-1192, Japan
Fukuoka, Fukuoka, 810-8563, Japan
Fukuoka, Fukuoka, 812-8582, Japan
Fukuoka, Iizuka, 820-8505, Japan
Fukuoka, Kitakyushu, 807-8556, Japan
Fukuoka, Kurume, 830-0011, Japan
Fukushima, Fukushima, 960-1295, Japan
Fukushima, Koriyama, 963-0197, Japan
Hiroshima, Hiroshima, 734-8530, Japan
Hyogo, Himeji, 670-8520, Japan
Hyogo, Kobe, 650-0047, Japan
Hyogo, Kobe, 653-0013, Japan
Kanagawa, Yokohama, 236-0051, Japan
Kumamoto, Kumamoto, 861-4193, Japan
Kyoto, Kyoto, 606-8507, Japan
Miyagi, Sendai, 980-8574, Japan
Nagasaki, Nagasaki, 852-8501, Japan
Osaka, Sakai, 590-0197, Japan
Osaka, Sakai, 591-8555, Japan
Osaka, Takatsuki, 569-8686, Japan
Saitama, Saitama, 330-8553, Japan
Shizuoka, Hamamatsu, 431-3192, Japan
Tochigi, Shimotsuke, 329-0498, Japan
Tokushima, Tokushima, 770-8503, Japan
Tokyo, Bunkyo-ku, 113-8431, Japan
Tokyo, Bunkyo-ku, 113-8519, Japan
Tokyo, Bunkyo-ku, 113-8603, Japan
Tokyo, Minato-ku, 105-8470, Japan
Tokyo, Mitaka, 181-8611, Japan
Tokyo, Ota-ku, 143-8541, Japan
Wakayama, Wakayama, 641-8510, Japan
One Tree Hill, Auckland, 1051, New Zealand
Tauranga South, 3112, New Zealand
Lørenskog, 1478, Norway
Muang, 11000, Thailand
Muang, 50200, Thailand
Ratchatewi, 10400, Thailand
Yenimahalle/ANKARA, 06560, Turkey (Türkiye)