A Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis Who Took Part in a Previous Study With Nerandomilast
Launched by BOEHRINGER INGELHEIM · Jan 25, 2024
Trial Information
Current as of July 16, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at how well a medication called BI 1015550 works over a longer period for people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF). To participate, you need to have previously taken BI 1015550 in another study without stopping early. The main goals of this trial are to see how well people tolerate this medication and if it helps improve their lung function or delays worsening symptoms.
If you join the study, you’ll take BI 1015550 in tablet form for up to 1 year and 10 months while continuing your usual treatments for lung fibrosis. You'll have regular visits with your doctor, where they’ll check your health and perform tests to measure how well your lungs are functioning. To be eligible, you should be between the ages of 65 and 74, have completed a prior study with BI 1015550, and meet certain health criteria. Overall, this trial hopes to provide valuable information about the long-term effects of BI 1015550 for individuals with these lung conditions.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Patients who completed treatment in the parent trials (1305-0014, 1305-0023, or 1305-0035) without prematurely discontinuing treatment permanently according to protocol (i.e. completed treatment with or without temporary treatment interruption)
- • 2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
- • 3. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. WOCBP taking oral contraceptives (OCs) also have to ensure the use of one barrier method during sexual intercourse with their partner, e.g., condom to account for the risk of potentially reduced efficacy of the OCs in the event of severe vomiting and diarrhoea. For France, fertile males must be ready and able to use acceptable methods of birth control
- Exclusion Criteria:
- • 1. Any disease that may put the patient at risk when participating in this trial at investigator's discretion.
- 2. Patient exhibits suicidality, in the clinical judgment of the investigator or according to the following criteria at Visit 1:
- • any suicidal behaviour (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behaviour)
- • any suicidal ideation of type 4 or 5 in the Columbia-Suicide Severity Rating Scale (C-SSRS) (i.e. active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent)
- • 3. Patients with clinically relevant severe depression at investigator's discretion or a Hospital Anxiety and Depression Scale (HADS) subscore \>14 at Visit 1.
- • 4. An occurrence of malignant neoplasm other than appropriately treated basal cell carcinoma or in situ squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix at Visit 1.
- • 5. Patient will undergo lung transplantation, with an assigned date of surgery.
- • 6. Patients with a Body Mass index (BMI) \<18.5 kg/m² that experienced an additional, unexplained and clinically significant (\>10%) weight loss during the parent trial
- • 7. At Visit 1, patients with ongoing Adverse Event of Special Interest (AESI), except for latent tuberculosis (suspected vasculitis, Drug Induced Liver Injury (DILI), severe infections) that led to temporary treatment interruption in the parent trial
- • 8. Patients who must or wish to take restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
- • Further exclusion criteria apply.
About Boehringer Ingelheim
Boehringer Ingelheim is a global, research-driven pharmaceutical company dedicated to improving health and quality of life through innovative therapies. Established in 1885 and headquartered in Ingelheim, Germany, the company focuses on the development of prescription medicines in key therapeutic areas, including respiratory diseases, cardiovascular health, oncology, and immunology. Boehringer Ingelheim is committed to advancing medical science through rigorous clinical trials and collaborative research, striving to bring novel treatments to patients while upholding the highest standards of safety and efficacy. With a strong emphasis on sustainability and corporate responsibility, the company aims to make a meaningful impact on global health challenges.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Burlington, Vermont, United States
Los Angeles, California, United States
Kansas City, Kansas, United States
Minneapolis, Minnesota, United States
Boston, Massachusetts, United States
Philadelphia, Pennsylvania, United States
Durham, North Carolina, United States
Boston, Massachusetts, United States
Madison, Wisconsin, United States
Boston, Massachusetts, United States
Adelaide, South Australia, Australia
Los Angeles, California, United States
Tampere, , Finland
Heidelberg, Victoria, Australia
Lebanon, New Hampshire, United States
Madrid, , Spain
Barcelona, , Spain
Dallas, Texas, United States
Philadelphia, Pennsylvania, United States
Vancouver, British Columbia, Canada
Saskatoon, Saskatchewan, Canada
Pittsburgh, Pennsylvania, United States
Garran, Australian Capital Territory, Australia
Sacramento, California, United States
Baltimore, Maryland, United States
Cincinnati, Ohio, United States
Birmingham, Alabama, United States
Omaha, Nebraska, United States
Seattle, Washington, United States
Cleveland, Ohio, United States
Falls Church, Virginia, United States
Nashville, Tennessee, United States
Washington, District Of Columbia, United States
Boston, Massachusetts, United States
New Haven, Connecticut, United States
Gainesville, Florida, United States
London, , United Kingdom
Bristol, , United Kingdom
Singapore, , Singapore
Ann Arbor, Michigan, United States
Philadelphia, Pennsylvania, United States
Atlanta, Georgia, United States
Barcelona, , Spain
Hamburg, , Germany
Singapore, , Singapore
Los Angeles, California, United States
Hannover, , Germany
Melbourne, Victoria, Australia
Camperdown, New South Wales, Australia
Reno, Nevada, United States
Aberdeen, , United Kingdom
Exeter, , United Kingdom
Rochester, Minnesota, United States
Zagreb, , Croatia
Alicante, , Spain
Valencia, , Spain
L'hospitalet De Llobregat, , Spain
New Orleans, Louisiana, United States
Baltimore, Maryland, United States
Southampton, , United Kingdom
Madrid, , Spain
Madrid, , Spain
Basel, , Switzerland
Khon Kaen, , Thailand
Barcelona, , Spain
Odense C, , Denmark
Madrid, , Spain
Alicante, , Spain
Barcelona, , Spain
Bilbao, , Spain
Santander, , Spain
Granada, , Spain
Malaga, , Spain
Mount Kisco, New York, United States
Beijing, , China
Lancaster, , United Kingdom
Edinburgh, , United Kingdom
Beijing, , China
London, , United Kingdom
Taichung, , Taiwan
Taipei, , Taiwan
Seoul, , Korea, Republic Of
Evanston, Illinois, United States
Tübingen, , Germany
Taichung, , Taiwan
Halifax, Nova Scotia, Canada
Kaohsiung, , Taiwan
Leuven, , Belgium
Seoul, , Korea, Republic Of
Barcelona, , Spain
Hamilton, , New Zealand
Denver, Colorado, United States
Sevilla, , Spain
Newark, Delaware, United States
Chermside, Queensland, Australia
Hellerup, , Denmark
Nürnberg, , Germany
Hemer, , Germany
Seoul, , Korea, Republic Of
Kuching, , Malaysia
Sevilla, , Spain
Tainan, , Taiwan
Chengdu, , China
Wuhan, , China
Suzhou, , China
Zagreb, , Croatia
Trois Rivieres, Quebec, Canada
Uppsala, , Sweden
Portland, Oregon, United States
Charleston, South Carolina, United States
Santiago De Compostela, , Spain
El Palmar, , Spain
Londonderry, , United Kingdom
Immenhausen, , Germany
Tucson, Arizona, United States
Salt Lake City, Utah, United States
Istanbul, , Turkey
Bruxelles, , Belgium
Modena, , Italy
Bergen, , Norway
Liège, , Belgium
Chengdu, , China
Shanghai, , China
Seoul, , Korea, Republic Of
Columbus, Ohio, United States
Taipei, , Taiwan
Murdoch, Western Australia, Australia
Bangkok Noi, , Thailand
Songkhla, , Thailand
Leeds, , United Kingdom
Seoul, , Korea, Republic Of
Wels, , Austria
Gent, , Belgium
Angers, , France
Hokkaido, Sapporo, , Japan
Kanagawa, Yokohama, , Japan
Seongnam, , Korea, Republic Of
Shanghai, , China
Budapest, , Hungary
Beijing, , China
Guangzhou, , China
Mendoza, , Argentina
Bruxelles, , Belgium
Yvoir, , Belgium
Nanjing, , China
Essen, , Germany
Milano, , Italy
Modena, , Italy
Siena, , Italy
Nieuwegein, , Netherlands
Wuhan, , China
Changsha, , China
Porto Alegre, , Brazil
Changhua, , Taiwan
Solingen, , Germany
Nis, , Serbia
Padova, , Italy
Madrid, , Spain
La Tronche, , France
Linköping, , Sweden
Hangzhou, , China
Shanghai, , China
Fukuoka, Iizuka, , Japan
Hyogo, Kobe, , Japan
Kaohsiung, , Taiwan
Caen, , France
Suresnes, , France
Oslo, , Norway
Oxford, , United Kingdom
Palma De Mallorca, , Spain
Clearwater, Florida, United States
Chesterfield, Missouri, United States
Yinchuan, , China
Helsinki, , Finland
Paris, , France
Paris, , France
Toulouse, , France
Bamberg, , Germany
Monza, , Italy
Aichi, Seto, , Japan
Miyagi, Sendai, , Japan
Tochigi, Shimotsuke, , Japan
Tokyo, Bunkyo Ku, , Japan
Tokyo, Shinjuku Ku, , Japan
Sremska Kamenica, , Serbia
Brest, , France
Berlin, , Germany
Pessac, , France
Ioannina, , Greece
Fukui, Yoshida Gun, , Japan
Fukuoka, Fukuoka, , Japan
Napoli, , Italy
Roma, , Italy
Oviedo, , Spain
Jerusalem, , Israel
São Paulo, , Brazil
Montreal, Quebec, Canada
Vienna, , Austria
Heidelberg, , Germany
Osaka, Osakasayama, , Japan
Tokyo, Bunkyo Ku, , Japan
Leuven, Vlaams Brabant, Belgium
Bucheon, , Korea, Republic Of
Shenzhen, , China
Mumbai, , India
Manchester, , United Kingdom
Belgrade, , Serbia
Vancouver, British Columbia, Canada
Oulu, , Finland
Turku, , Finland
Bonn, , Germany
Catania, , Italy
Chiba, Chiba, , Japan
New York, New York, United States
Goiania, , Brazil
Caba, , Argentina
Hangzhou, , China
Paris, , France
Patras, , Greece
Fukuoka, Fukuoka, , Japan
Hiroshima, Hiroshima, , Japan
Kumamoto, Kumamoto, , Japan
Nagasaki, Nagasaki, , Japan
Tokyo, Mitaka, , Japan
Matosinhos, , Portugal
Tokyo, Minato Ku, , Japan
Winston Salem, North Carolina, United States
Seoul, Jongno Gu, Korea, Republic Of
George Town, , Malaysia
Quebec, , Canada
Coswig, , Germany
Seoul, , Korea, Republic Of
Marseille, , France
Roma, , Italy
Nice, , France
Rennes, , France
Seoul, , Korea, Republic Of
New York, New York, United States
Florida, , Argentina
Talca, , Chile
Bron, , France
Fukuoka, Kurume, , Japan
Hokkaido, Sapporo, , Japan
Hyogo, Himeji, , Japan
Osaka, Sakai, , Japan
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Tokushima, Tokushima, , Japan
Tokyo, Ota Ku, , Japan
Guangzhou, , China
Hyogo, Kobe, , Japan
Shimane, Izumo, , Japan
Seoul, , Korea, Republic Of
Rotterdam, , Netherlands
Edmonton, Alberta, Canada
Pozuelo De Alarcón, , Spain
Fukuoka, Kitakyushu, , Japan
Tokyo, Shinjuku Ku, , Japan
Birmingham, , United Kingdom
Kagawa, Kita Gun, , Japan
Galdakao, , Spain
Antwerpen, , Belgium
Foggia, , Italy
Monterrey, , Mexico
Shanghai, , China
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Tianjin, , China
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Rosario, , Argentina
Providencia, Santiago De Chile, , Chile
Gdansk, , Poland
Hangzhou, , China
Windsor, Ontario, Canada
São Bernardo Do Campo, , Brazil
Hefei, , China
Haifa, , Israel
Loxahatchee Groves, Florida, United States
Brescia, , Italy
Wenzhou, , China
Shanghai, , China
Spearwood, Western Australia, Australia
Sao Paulo, , Brazil
Shenzhen, , China
Palma De Mallorca, , Spain
Tokyo, Shinjuku Ku, , Japan
Xi'an, , China
Jinhua, , China
Papatoetoe, , New Zealand
Barra Mansa, , Brazil
Ankara, , Turkey
Shenyang, , China
Westmead, New South Wales, Australia
Kissimmee, Florida, United States
Moncton, New Brunswick, Canada
Seoul, , Korea, Republic Of
Kragujevac, , Serbia
Franklin, Tennessee, United States
Caba, , Argentina
Chengdu, , China
Hannover, , Germany
Thessaloniki, , Greece
Chihuahua, , Mexico
Wuxi, , China
Ningbo, , China
Roma, , Italy
Nordbyhagen, , Norway
Swidnik, , Poland
Wuhan, , China
East Providence, Rhode Island, United States
Vienna, , Austria
Tallinn, , Estonia
Stralsund, , Germany
Atlanta, Georgia, United States
Kuala Lumpur, , Malaysia
Dijon, , France
Rouen, , France
Bobigny, , France
Le Kremlin Bicêtre, , France
Oaxaca, , Mexico
Spearwood, Western Australia, Australia
Muang, , Thailand
Ratchatewi, , Thailand
Nantes, , France
Fukushima, Koriyama, , Japan
Wakayama, Wakayama, , Japan
One Tree Hill, Auckland, , New Zealand
Tauranga South, , New Zealand
Chermside, Queensland, Australia
Yichang, , China
Osaka, Takatsuki, , Japan
Capital Federal, , Argentina
Xuzhou, , China
Fukushima, Fukushima, , Japan
Durban, , South Africa
Hamilton, Ontario, Canada
Hangzhou, , China
Dublin 15, , Ireland
Tbilisi, , Georgia
Warsaw, , Poland
Budapest, , Hungary
Mar Del Plata, , Argentina
Quilmes, , Argentina
Krems, , Austria
Debrecen, , Hungary
Firenze, , Italy
Torrette Di Ancona (Ancona), , Italy
Tbilisi, , Georgia
Ciudad De Mexico, , Mexico
Belo Horizonte,Minas Gerais, , Brazil
Jiaxing, , China
Saitama, Saitama, , Japan
Hohhot, , China
Guanajuato, , Mexico
Golnik, , Slovenia
Ningbo, , China
Montreal, Quebec, Canada
Vienna, , Austria
Katowice, , Poland
Salzburg, , Austria
Coyoacan, , Mexico
Warsaw, , Poland
Riyadh, , Saudi Arabia
Ankara, , Turkey
Yenimahalle/Ankara, , Turkey
Lille, , France
Kajang, , Malaysia
Tel Aviv, , Israel
Großhansdorf, , Germany
Lisboa, , Portugal
Vila Nova De Gaia, , Portugal
München, , Germany
Stuttgart, , Germany
Guaynabo, , Puerto Rico
Curitiba, , Brazil
Coimbra, , Portugal
Braga, , Portugal
Royal Oak, Michigan, United States
Ciudad De Mexico, , Mexico
Leiden, Zuid Holland, Netherlands
C.A.B.A, , Argentina
Zagreb, , Croatia
Kelowna, British Columbia, Canada
Forli', , Italy
Heerlenheerlen, , Netherlands
Reims, , France
Praha 4, , Czechia
Ahrensburg, , Germany
Heraclion, , Greece
Macquarie Park, , Australia
Barcelona, , Spain
Winston Salem, North Carolina, United States
C.A.B.A, , Argentina
Marseille, , France
Hamburg, , Germany
Antalya, , Turkey
Exeter, , United Kingdom
Murray, Utah, United States
Ahrensburg, , Germany
Milano, , Italy
Porto Alegre Rs, , Brazil
Vancouver, British Columbia, Canada
Mumbai, , India
Beer Yaakov, , Israel
Leiden, , Netherlands
Rotterdam, , Netherlands
Mount Edgecombe, , South Africa
Coswig, , Germany
George Town, , Malaysia
Firenze, , Italy
Napoli, , Italy
Saskatoon, Saskatchewan, Canada
Tallinn, , Estonia
Forli', , Italy
Ahrensburg, , Germany
Caen, , France
Tbilisi, , Georgia
Swidnik, , Poland
Hohhot, , China
Nice, , France
Tbilisi, , Georgia
Coswig, , Germany
Ciudad De Mexico, , Mexico
Coyoacan, , Mexico
Warsaw, , Poland
Guaynabo, , Puerto Rico
L'hospitalet De Llobregat, , Spain
Ankara, , Turkey
Ankara, , Turkey
Yenimahalle/Ankara, , Turkey
Helsinki, , Finland
Oslo, , Norway
Antalya, , Turkey
Milano, , Italy
Tokyo, Shinjuku Ku, , Japan
Brest, , France
Coyoacan, , Mexico
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported