A Clinical Study to Test How Effective and Safe GLPG1690 is for Participants With Idiopathic Pulmonary Fibrosis (IPF) When Used Together With Standard of Care

Idiopathic Pulmonary Fibrosis Clinical Trial

— ISABELA2  

Official title:

A Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Two Doses of GLPG1690 in Addition to Local Standard of Care for Minimum 52 Weeks in Subjects With Idiopathic Pulmonary Fibrosis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03733444
• Other study ID #: GLPG1690-CL-304
• Secondary ID: 2018-001406-29
• Status: Terminated
• Phase: Phase 3
• Start date: November 5, 2018
• Est. completion date: March 30, 2021

Study information

• Verified date: July 2022
• Source: Galapagos NV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of this study was to see how GLPG1690 works together with the current standard treatment on your lung function and IPF disease in general. The study also investigated how well GLPG1690 is tolerated (for example if you get any side effects while on study drug).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 781
• Est. completion date: March 30, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Male or female subject aged =40 years on the day of signing the Informed Consent Form (ICF).

• A diagnosis of IPF within 5 years prior to the screening visit, as per applicable American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Association (ALAT) guidelines at the time of diagnosis.

• Chest high-resolution computed tomography (HRCT) historically performed within 12 months prior to the screening visit and according to the minimum requirements for IPF diagnosis by central review based on subject's HRCT only (if no lung biopsy (LB) available), or based on both HRCT and LB (with application of the different criteria in either situation). If an evaluable HRCT <12 months prior to screening is not available, an HRCT can be performed at screening to determine eligibility, according to the same requirements as the historical HRCT.

• Subjects receiving local standard of care for the treatment of IPF, defined as either pirfenidone or nintedanib, at a stable dose for at least two months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason). A stable dose is defined as the highest dose tolerated by the subject during those two months.

• The extent of fibrotic changes is greater than the extent of emphysema on the most recent HRCT scan (investigator-determined).

• Meeting all of the following criteria during the screening period: FVC =45% predicted of normal, Forced expiratory volume in 1 second (FEV1)/FVC =0.7, diffusing capacity of the lung for carbon monoxide (DLCO) corrected for Hb =30% predicted of normal.

• Estimated minimum life expectancy of at least 30 months for non IPF related disease in the opinion of the investigator.

• Male subjects and female subjects of childbearing potential agree to use highly effective contraception/preventive exposure measures from the time of first dose of investigational medicinal product (IMP) (for the male subject) or the signing of the ICF (for the female subject), during the study, and until 90 days (male) or 30 days (female) after the last dose of IMP.

• Able to walk at least 150 meters during the 6-Minute Walk Test (6MWT) at screening Visit 1; without having a contraindication to perform the 6MWT or without a condition putting the subject at risk of falling during the test (investigator's discretion). The use of a cane is allowed, the use of a stroller is not allowed at all for any condition. At Visit 2, for the oxygen titration test, resting oxygen saturation (SpO2) should be =88% with maximum 6 L O2/minute; during the walk, SpO2 should be =83% with 6 L O2/minute or =88% with 0, 2 or 4 L O2/minute.

Exclusion Criteria:

• History of malignancy within the past 5 years (except for carcinoma in situ of the uterine cervix, basal cell carcinoma of the skin that has been treated with no evidence of recurrence, prostate cancer that has been medically managed through active surveillance or watchful waiting, squamous cell carcinoma of the skin if fully resected, and Ductal Carcinoma In Situ).

• Clinically significant abnormalities detected on ECG of either rhythm or conduction, a QT interval corrected for heart rate using Fridericia's formula (QTcF) >450 ms, or a known long QT syndrome. Patients with implantable cardiovascular devices (e.g. pacemaker) affecting the QT interval time may be enrolled in the study based upon investigator judgment following cardiologist consultation if deemed necessary, and only after discussion with the medical monitor.

• Acute IPF exacerbation within 6 months prior to screening and/or during the screening period. The definition of an acute IPF exacerbation is as follows: Previous or concurrent diagnosis of IPF; Acute worsening or development of dyspnea typically < 1 month duration; Computed tomography with new bilateral ground-glass opacity and/or consolidation superimposed on a background pattern consistent with usual interstitial pneumonia pattern and deterioration not fully explained by cardiac failure or fluid overload.

• Lower respiratory tract infection requiring treatment within 4 weeks prior to screening and/or during the screening period.

• Interstitial lung disease associated with known primary diseases (e.g. sarcoidosis and amyloidosis), exposures (e.g. radiation, silica, asbestos, and coal dust), or drugs (e.g. amiodarone).

• Diagnosis of severe pulmonary hypertension (investigator determined).

• Unstable cardiovascular, pulmonary (other than IPF), or other disease within 6 months prior to screening or during the screening period (e.g. acute coronary disease, heart failure, and stroke).

• Had gastric perforation within 3 months prior to screening or during screening, and/or underwent major surgery within 3 months prior to screening, during screening or have major surgery planned during the study period.

• History of nintedanib-related increase in ALT and/or AST of >5 x upper limit of the normal range (ULN) and increased susceptibility to elevated LFT; moderate to severe hepatic impairment (Child-Pugh B or C) and/or abnormal liver function test (LFT) at screening, defined as aspartate aminotransferase (AST), and/or alanine aminotransferase (ALT), and/or total bilirubin =1.5 x upper limit of the normal range (ULN), and/or gamma glutamyl transferase (GGT) =3 x ULN. Retesting is allowed once for abnormal LFT.

• Abnormal renal function defined as estimated creatinine clearance, calculated according to Cockcroft-Gault calculation (CCr) <30 mL/min. Retesting is allowed once.

• Use of any of the following therapies within 4 weeks prior to screening and during the screening period, or planned during the study: warfarin, imatinib, ambrisentan, azathioprine, cyclophosphamide, cyclosporine A, bosentan, methotrexate, sildenafil (except for occasional use), prednisone at steady dose >10 mg/day or equivalent.

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Drug:
• GLPG1690
GLPG1690, film-coated tablets for oral use.
• Placebo
Matching placebo, film-coated tablets for oral use.

Locations

Country	Name	City	State
Argentina	Centro Médico Dra de Salvo	Buenos Aires
Argentina	Hospital Privado Centro Médico de Córdoba	Córdoba
Argentina	CEMER Centro Médico de Enfermedades Respiratorias	Florida
Argentina	Hospital Zonal Especializado de Agudos y Crónicos Dr. Antonio A. Cetrangolo	Luján
Argentina	Instituto de Investigaciones Clínicas Mar Del Plata	Mar Del Plata
Argentina	Fundacion Scherbovsky	Mendoza
Canada	South Health Campus	Calgary
Canada	Hôtel Dieu Du Centre Hospitalier de L'université de Montréal	Montréal
Canada	McGill University Health Centre Research Institute	Montréal
Canada	Institut Universitaire de Cardiologie et de Pneumologie	Québec
Canada	Toronto General Hospital	Toronto
Canada	Pacific Lung Research Center	Vancouver
Canada	Vancouver General Hospital	Vancouver
Canada	Dr Anil Dhar Professional Medicine Corporation	Windsor
France	Hôpital Nord AP-HM	Marseille
France	Centre Hospitalier Regional Universitaire Montpellier	Montpellier
France	Groupe Hospitalier Bichat Claude Bernard	Paris
France	CHU de Reims	Reims
Germany	Ruhrlandklinik	Essen
Germany	Praxis Dr. med. Claus Keller	Frankfurt
Germany	Universitätsmedizin Greifswald Klinik und Poliklinik für Innere Medizin B	Greifswald
Germany	Pneumologisches Forschungsinstitut	Großhansdorf
Germany	Lungenfachklinik Immenhausen	Immenhausen
Germany	Kliniken der Stadt Koln GmbH	Köln
Germany	Krankenhaus Bethanien - Klinik für Pneumologie und Allergologie	Solingen
Hungary	Semmelweis Egyetem	Budapest
Hungary	Veszprem Megyei Tudogyogyintezet	Farkasgyepu
Hungary	Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktató Kórház	Miskolc
Hungary	Tüdogyógyintézet Törökbálint	Törökbálint
Israel	Barzilai Medical Center	Ashkelon
Israel	Lady Davis Carmel Medical Center	Haifa
Israel	Hadassah University Hospital Ein Kerem	Jerusalem
Israel	Meir Medical Center	Kfar Saba
Israel	Rabin Medical Center - PPDS	Petah tikva
Israel	Kaplan Medical Center	Re?ovot
Italy	Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi	Ancona
Italy	Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele	Catania	Sicilia
Italy	Presidio Ospedaliero GB Morgagni L Pierantoni	Forlì
Italy	Ospedale S. Giuseppe Multimedica	Milano
Italy	Università Cattolica Del S Cuore	Roma
Italy	Azienda Ospedaliera Universitaria Senese	Siena
Japan	Juntendo University Hospital	Bunkyo
Japan	Fukuoka University Hospital	Fukuoka
Japan	National Hospital Organization Kyushu Medical Center	Fukuoka
Japan	NHO Okinawa Hospital	Ginowan
Japan	Hamamatsu University School of Medicine	Hamamatsu
Japan	Tenryu Hospital	Hamamatsu	Shizuoka
Japan	National Hospital Organization Himeji Medical Center	Himeji
Japan	Hiroshima Prefectural Hospital	Hiroshima
Japan	Kobe City Medical Center General Hospital	Hyogo
Japan	Saiseikai Kumamoto Hospital	Kumamoto
Japan	Nagasaki University Hospital	Nagasaki
Japan	Nagoya University Hospital	Nagoya
Japan	National Hospital Organization Ibarakihigashi National Hospital	Naka	Ibaraki
Japan	Japanese Red Cross Okayama Hospital	Okayama
Japan	National Hospital Organization Kinki-Chuo Chest Medical Center	Sakai
Japan	Tohoku Medical and Pharmaceutical Hospital	Sendai
Japan	Tosei General Hospital	Seto
Japan	Tokyo Medical University Hospital	Shinjuku-Ku
Japan	Tokushima University Hospital	Tokushima
Japan	Center Hospital of the National Center for Global Health and Medicine	Tokyo
Japan	Kanagawa Cardiovascular and Respiratory Center	Yokohama
Korea, Republic of	Soon Chun Hyang University Hospital Bucheon	Bucheon	Gyeonggi-do
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do
Korea, Republic of	Asan Medical Center - PPDS	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Soon Chun Hyang University Hospital Seoul	Seoul
Mexico	Instituto Nacional De Enfermedades (INER)	Ciudad de mexico
Mexico	Centro de Investigación Medico Biologica y de Terapia Avanzada S.C.	Guadalajara
Mexico	Hospital Universitatorio Dr. Jose Eleuterio González	Monterrey
Mexico	Unidad de Investigación Clínica En Medicina SC	Monterrey
Netherlands	OLVG locatie Oost	Amsterdam
Netherlands	VU Medisch Centrum	Amsterdam
Netherlands	Martini Ziekenhuis	Groningen
Netherlands	Zuyderland Medisch Centrum	Heerlen
Netherlands	St. Antonius Ziekenhuis	Nieuwegein
Netherlands	Erasmus MC	Rotterdam
New Zealand	Greenlane Clinical Centre	Auckland
New Zealand	NZ Respiratory & Sleep Institute	Auckland
New Zealand	Christchurch Hospital	Christchurch
New Zealand	Waikato Hospital	Hamilton
Poland	Centrum Medycyny Oddechowej Mroz sp. j.	Bialystok
Poland	Uniwersyteckie Centrum Kliniczne - PPDS	Gdansk
Poland	PULMAG Arkadiusz Brodowski, Grzegorz Gasior S. C.	Katowice
Poland	GRAZYNA JASIENIAK-PINIS ATOPIA Niepubliczny Zaklad Opieki Zdrowotnej Poradnie Specjalistyczne	Kraków
Poland	SP ZOZ Szpital Uniwersytecki w Krakowie	Kraków
Poland	SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im Norberta Barlickiego Uniwersytetu Medycznego w Lodzi	Lódz
Poland	ETG Lublin	Lublin
Poland	ETG Warszawa	Warszawa
South Africa	Dr Ismail Abdullah Private Practice	Cape Town
South Africa	Tygerberg Hospital	Cape Town
South Africa	University of Cape Town Lung Institute (UCTLI)	Cape Town
South Africa	Ethekwini Hospital	Durban
South Africa	Gateway Private Hospital	Durban
South Africa	Milpark Hospital	Johannesburg
United States	Albany Medical Center	Albany	New York
United States	Lovelace Scientific Resources Inc	Albuquerque	New Mexico
United States	University of Michigan Health System (UMHS)	Ann Arbor	Michigan
United States	Emory University	Atlanta	Georgia
United States	Piedmont Healthcare	Atlanta	Georgia
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Brigham and Womens Hospital	Boston	Massachusetts
United States	University of Vermont	Burlington	Vermont
United States	Medical University of South Carolina - PPDS	Charleston	South Carolina
United States	Cardio Pulmonary Associates	Chesterfield	Missouri
United States	University of Chicago Medical Center	Chicago	Illinois
United States	St. Francis Medical Institute	Clearwater	Florida
United States	Ohio State University	Columbus	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	Inova Fairfax Hospital	Falls Church	Virginia
United States	Spectrum Health Medical Group	Grand Rapids	Michigan
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	Keck School of Medicine of USC	Los Angeles	California
United States	Loyola University Medical Center	Maywood	Illinois
United States	University of Miami	Miami	Florida
United States	University of Minnesota Medical Center	Minneapolis	Minnesota
United States	Columbia University Medical Center	New York	New York
United States	Renstar Medical Research	Ocala	Florida
United States	Central Florida Pulmonary Group PA	Orlando	Florida
United States	Temple Lung Center	Philadelphia	Pennsylvania
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Arizona Pulmonary Specialists	Phoenix	Arizona
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	UC Davis Medical Center	Sacramento	California
United States	University of California, San Francisco Medical Center	San Francisco	California
United States	Atlantic Respiratory Institute	Summit	New Jersey
United States	Mercy Health - St. Vincent Medical Center	Toledo	Ohio
United States	University of Arizona College of Medicine	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Galapagos NV

Countries where clinical trial is conducted

United States,  Argentina,  Canada,  France,  Germany,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  New Zealand,  Poland,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Annual Rate of Decline in Forced Vital Capacity (FVC) up to Week 52	FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.	Baseline up to week 52
Secondary	Percentage of Participants With Disease Progression Up to 52 Weeks	Disease progression was defined as the composite occurrence of more than or equal to (>=)10 percent (%) absolute decline in percent predicted forced vital capacity (%FVC) or all-cause mortality. FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.	Up to week 52
Secondary	Percentage of Participants With Respiratory-Related Hospitalization Until End of Study (EoS)	Percentage of participants with respiratory related to hospitalization were reported in this measure.	Up to EoS (week 125)
Secondary	Change From Baseline in St.George's Respiratory Questionnaire (SGRQ) Total Score at Week 52	SGRQ is a 50-item paper questionnaire designed to measure and quantify the impact of chronic respiratory disease on health-related quality of life (QOL) and well-being, split into 3 domains: symptoms score assessing the frequency and severity of respiratory symptoms (Items 1-8), activity score assessing the effects of breathlessness on mobility and physical activity (Items 11-17 and 36 to 44), and impacts score assessing the psychosocial impact of the disease (Items 9-10, 18-35 and 45-50). Each item has a specific weight.; Domain scores = 100 * summed weights from positive items in that component/sum of maximum weights for all non-missing items in that component; Total score = 100 * summed weights from positive items in the questionnaire/sum of maximum weights for all non-missing items in the questionnaire; Scores were weighted such that each domain score ranged from 0 to 100 and the total score ranged from 0 to 100, with higher scores indicating the poorer health-related QOL.	Baseline, week 52
Secondary	Annual Rate of Decline of FVC Until EoS	FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.	Baseline up to EoS (week 125)
Secondary	Percentage of Participants With Disease Progression Until EoS	Disease progression was defined as the composite occurrence of >=10% absolute decline in percent predicted %FVC or all-cause mortality. FVC (in mL]) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.	Up to EoS (week 125)
Secondary	Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 100	SGRQ is a 50-item paper questionnaire designed to measure and quantify the impact of chronic respiratory disease on health-related quality of life (QOL) and well-being, split into 3 domains: symptoms score assessing the frequency and severity of respiratory symptoms (Items 1-8), activity score assessing the effects of breathlessness on mobility and physical activity (Items 11-17 and 36 to 44), and impacts score assessing the psychosocial impact of the disease (Items 9-10, 18-35 and 45-50). Each item has a specific weight.; Domain scores = 100 * summed weights from positive items in that component/sum of maximum weights for all non-missing items in that component; Total score = 100 * summed weights from positive items in the questionnaire/sum of maximum weights for all non-missing items in the questionnaire; Scores were weighted such that each domain score ranged from 0 to 100 and the total score ranged from 0 to 100, with higher scores indicating the poorer health-related QOL.	Baseline, week 100
Secondary	Percentage of Participants With All Cause Hospitalization Until EoS	Percentage of participants with all cause hospitalization was reported for this measure.	Up to EoS (week 125)
Secondary	Percentage of Participants With Respiratory Related Mortality Until EoS	Percentage of participants with respiratory related mortality until end of study were reported for this study.	Up to EoS (week 125)
Secondary	Percentage of Participants Hospitalized for Non-Elective Lung Transplant Until EoS	Percentage of Participants who were hospitalized for lung transplant were reported for this measure.	Up to EoS (week 125)
Secondary	Percentage of Participants With Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation Until EoS	Percentage of participants with acute IPF exacerbation until end of study were reported for this measure.	Up to EoS (week 125)
Secondary	Percentage of Participants With All Cause Mortality or Hospitalization for Non-elective Lung Transplant Until EoS	Percentage of participants with all-cause mortality or hospitalization for non-elective lung transplant were reported for this measure.	Up to EoS (week 125)
Secondary	Percentage of Participants With All Cause Mortality, Hospitalization for Non-elective Lung Transplant or Hospitalization for Qualifying for Lung Transplant Until EoS	Percentage of participants with all-cause mortality or hospitalization for qualifying for lung transplant were reported for this measure.	Up to EoS (week 125)
Secondary	Percentage of Participants With All-Cause Mortality or Hospitalization That Meets >=10% Absolute Decline in %FVC or Respiratory-Related Hospitalization Until EoS	Percentage of participants with all-cause mortality or respiratory related hospitalization that meets >=10% absolute decline in %FVC or respiratory-related hospitalization were reported for this measure.	Up to EoS (week 125)
Secondary	Percentage of Participants With All-Cause Mortality or Respiratory-Related Hospitalizations Until EoS	Percentage of participants with all-cause mortality or respiratory related hospitalization were reported for this measure.	Up to EoS (week 125)
Secondary	FVC at Week 52	FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.	Week 52
Secondary	Change From Baseline in FVC at Week 52	FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.	Baseline, week 52
Secondary	Percent Change From Baseline in FVC at Week 52	FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.	Baseline, week 52
Secondary	FVC at Week 100	FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.	Week 100
Secondary	Change From Baseline in FVC at Week 100	FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.	Baseline, week 100
Secondary	Percent Change From Baseline in FVC at Week 100	FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.	Baseline, week 100
Secondary	Percentage of Participants With Absolute Categorical Change From Baseline in Percent FVC at Week 52: FVC Change Within =5	FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.	Baseline, week 52
Secondary	Percentage of Participants With Absolute Categorical Change From Baseline in Percent FVC at Week 100: FVC Change Within =5	FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.	Baseline, week 100
Secondary	Percentage of Participants With Absolute Categorical Change From Baseline in Percent FVC at Week 52: FVC Change Within =10	FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.	Baseline, week 52
Secondary	Percentage of Participants With Absolute Categorical Change From Baseline in Percent FVC at Week 100: FVC Change Within =10	FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.	Baseline, week 100
Secondary	Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs	Safety was assessed by adverse events (AEs), which included abnormalities identified during a medical test (e.g. laboratory tests, vital signs, electrocardiogram, etc.) if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study drug or was clinically significant. A Treatment emergent AE (TEAE) was defined as any AE that started or worsened after the first dose of study drug up to 30 days after the last dose of study drug. AEs were considered serious (SAEs) if the AE resulted in death, was life-threatening, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, resulted in congenital anomaly, or birth defect or required inpatient hospitalization or led to prolongation of hospitalization.	Baseline up to EoS (up to Week 125)
Secondary	Changes From Baseline in Leicester Cough Questionnaire (LCQ) Total Score and Individual Domain Score at Week 52 and Week 100	Cough was evaluated using the LCQ. The LCQ is a 19-item questionnaire split into three domains: physical, psychological, and social. Scores were calculated by domain (range from 1 to 7) and then the total score was calculated by adding the individual domain score. Total score ranged from 3 to 21, with higher scores indicated a better health status.	Baseline, week 52, week 100
Secondary	Changes From Baseline in Visual Analogue Score (VAS): Cough at Week 52 and Week 100	Cough was assessed using VAS score, ranged from 0 (no cough) to 100 millimeter (mm) (worst possible cough).	Baseline, week 52, week 100
Secondary	Change From Baseline in Visual Analogue Score (VAS): Urge to Cough at Week 52 and Week 100	Urge to Cough was assessed using VAS score, ranged from 0 (no urge to cough) to 100 mm (highest urge to cough).	Baseline, week 52, week 100
Secondary	Changes From Baseline in EuroQOL 5-Dimensions Questionnaire at Week 52 and Week 100	EuroQol outcome measurements was a printed 20 centimeter (cm) EQ visual analogue scale (EQ VAS) that appears somewhat like a thermometer, on which a score from 0 (worst imaginable health state or death) to 100 (best imaginable health state) was marked by the participant (or, when necessary, their proxy) with the scale in view.	Baseline, week 52, week 100
Secondary	Changes From Baseline in King's Brief Interstitial Lung Disease (K-BILD) at Week 52 and Week 100	The King's Brief Interstitial Lung Disease questionnaire (K-BILD) was specifically developed to analyze the health status of participants with OLD, the questionnaire consists of of 15 items (assessed by participants on scale ranging from 1 to 7, where 1 and 7 represents worst and best health status). Items are compiled into 3 domains: breathlessness and activities (range: 0-21), psychological (range: 0-34), and chest symptoms (range: 0-8). To score the K-BILD, the Likert response scale weightings for individual items are combined and scores are transformed to a range of 0-100 by using logit values (higher scores indicate better health status).	Baseline, week 52, week 100
Secondary	Area Under The Concentration Time Curve of Ziritaxtestat	Area under the concentration time curve of ziritaxtestat was reported	Sparse samples collected on day 1 pre-dose, day 85 post-dose, day 237 post-dose, day 183 pre-dose, day 365 pre-dose
Secondary	Maximum Observed Plasma Concentration (Cmax) of Ziritaxtestat	Maximum Observed Plasma Concentration of Ziritaxtestat was reported.	Sparse samples collected on day 1 pre-dose, day 85 post-dose, day 237 post-dose, day 183 pre-dose, day 365 pre-dose
Secondary	Change From Baseline in Functional Exercise Capacity, Assessed by The 6-Minute Walk Test (6MWT) Distance, at Week 52 and Week 100	The 6MWT depicts the total distance covered by a participant during 6 minutes walking.	Baseline, week 52, week 100
Secondary	Change From Baseline in Diffusing Capacity of Lung for Carbon Monoxide (DLCO) (Corrected for Hemoglobin [Hb]) at Week 52 and Week 100	Change from baseline in diffusing capacity of the lung for carbon monoxide (percent predicted hemoglobin level corrected) was reported for this measure.; mmol/min/kPa: Millimole per minute per kilopascal	Baseline, week 52 and week 100