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

Idiopathic Pulmonary Fibrosis Clinical Trial

— ISABELA1  

Official title:

A Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled Multicenter 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: NCT03711162
• Other study ID #: GLPG1690-CL-303
• Secondary ID: 2018-001405-87
• Status: Terminated
• Phase: Phase 3
• Start date: November 28, 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 your 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 got any side effects while on study drug).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 525
• 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
Australia	Royal Adelaide Hospital	Adelaide
Australia	Flinders Medical Centre	Bedford Park
Australia	Box Hill Hospital	Box Hill
Australia	Corte Royal Prince Alfred Hospital	Camperdown
Australia	Lung Research Queensland	Chermside
Australia	Concord Repatriation General Hospital	Concord
Australia	St Vincent's Hospital Sydney	Darlinghurst
Australia	Austin Health	Heidelberg
Australia	Respiratory Clinical Trials Pty Ltd	Kent Town
Australia	The Alfred Hospital	Melbourne
Belgium	ZNA Middelheim	Antwerp
Belgium	Cliniques Universitaires Saint-Luc	Brussels
Belgium	Hôpital Erasme	Brussels
Belgium	UZ Leuven	Leuven
Belgium	CHU UCL Namur asbl - Site Godinne	Yvoir
Brazil	Irmandade Da Santa Casa de Misericordia de Porto Alegre	Porto Alegre
Brazil	Faculdade de Medicina Do ABC	Santo André
Chile	Hospital Clínico Regional de Concepción Dr Guillermo Grant Benavente	Concepción
Chile	Centro de Investigación Curico	Curicó
Chile	Centro Respiratorio Integral LTDA. (CENRESIN)	Quillota
Chile	Centro de Investigaciones Medicas Respiratorias CIMER	Santiago
Chile	Hospital Dr Sotero Del Rio	Santiago
Chile	Instituto Nacional Torax	Santiago
Chile	Centro de Investigacion del Maule	Talca
Chile	Hospital Carlos Van Buren	Valparaíso
Chile	CINVEC- Estudos Clínicos Quinta Región Limitada	Viña Del Mar
Czechia	Fakultni nemocnice Brno	Brno
Czechia	Fakultni nemocnice Ostrava	Ostrava
Czechia	Nemocnice Na Bulovce	Praha
Czechia	Thomayerova nemocnice	Praha
Denmark	Aarhus Universitetshospital	Aarhus
Denmark	Gentofte Hospital	Hellerup
Denmark	Odense Universitetshospital	Odense
Germany	Zentralklinik Bad Berka GmbH	Bad Berka
Germany	Evangelische Lungenklinik	Berlin
Germany	Fachkrankenhaus Coswig	Coswig
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Thorax Klinik	Heidelberg
Germany	Universitatsklinikum Leipzig	Leipzig
Germany	Klinikum Rosenheim	Rosenheim
Greece	Attikon University General Hospital	Athens
Greece	Sotiria Chest Hospital of Athens	Athens
Greece	University General Hospital of Heraklion	Iraklio
Greece	University General Hospital of Larissa	Larissa
Greece	Georgios Papanikolaou General Hospital of Thessaloniki	Thessaloníki
Japan	Tenryu Hospital	Hamamatsu
Japan	Saiseikai Kumamoto Hospital	Kumamoto
Japan	National Hospital Organization Kinki-Chuo Chest Medical Center	Sakai
Japan	Tosei General Hospital	Seto
Japan	Center Hospital of the National Center for Global Health and Medicine	Tokyo
Japan	National Hospital Organization Kyushu Medical Center	Tokyo
Japan	Kanagawa Cardiovascular and Respiratory Center	Yokohama
Peru	Hospital Chancay y Servicios Basicos de Salud	Chancay
Peru	Hospital Nacional Guillermo Almenara Irigoyen ESSALUD	Lima
Peru	Clinica Internacional - PPDS	Lima Cercado
Peru	Clinica Ricardo Palma - PPDS	San Isidro
Peru	Clinica Providencia (Inverconsult Sociedad Anonima)	San Miguel
Peru	Clinica San Pablo	Santiago De Surco
Spain	Hospital Clinical de Barcelona	Barcelona
Spain	Hospital Universitario de Bellvitge, Hospitalet De Llobregat	Barcelona
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Universitario de La Princesa	Madrid
Spain	Clinica Universidad Navarra	Pamplona
Spain	Hospital Universitario Marques de Valdecilla	Santander
Spain	Consorcio Hospital General Universitario de Valencia	Valencia
Spain	CHUVI - H.U. Alvaro Cunquerio	Vigo	Pontevedra
Taiwan	Kaohsiung Medical University Hospital	Kaohsiung City
Taiwan	Far Eastern Memorial Hospital	New Taipei City
Taiwan	Taipei Medical University Shuang Ho Hospital	New Taipei City
Taiwan	National Taiwan University Hospital	Taipei
Turkey	Süreyyapasa Gögüs Hastaliklari Ve Gögüs Cerrahisi Egitim Ve Arastirma Hastanesi	Istanbul
Turkey	Ege Universitesi Tip Fakultesi Hastanesi Gögus Hastaliklari Anabilim Dali	Izmir
Turkey	Uludag Universitesi Tip Fakultesi Hastanesi Gögüs Hastaliklari Anabilim Dali	Izmir
Turkey	Mersin Üniversitesi Tip Fakültesi Hastanesi Gögüs Hastaliklari Polikinligi	Mersin
United Kingdom	Birmingham Heartlands Hospital	Birmingham
United Kingdom	Southmead Hospital	Bristol
United Kingdom	Papworth Hospital	Cambridge
United Kingdom	Castle Hill Hospital	Cottingham
United Kingdom	Royal Devon and Exeter Hospital NHS Trust	Exeter
United Kingdom	Aintree University Hospital NHS Foundation Trust	Liverpool
United Kingdom	Royal Brompton Hospital	London
United Kingdom	Wythenshawe Hospital - PPDS	Manchester
United Kingdom	The Newcastle Upon Tyne Hospitals NHS Foundation Trust	Newcastle
United Kingdom	Nottingham City Hospital	Nottingham
United Kingdom	Northern General Hospital	Sheffield
United States	University of Colorado	Aurora	Colorado
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	Caritas St. Elizabeth's Medical Center	Boston	Massachusetts
United States	Massachusetts General Hospital, Division of Pulmonary and Critical Care Medicine	Boston	Massachusetts
United States	PAB Clinical Research - ClinEdge - PPDS	Brandon	Florida
United States	University of Virginia	Charlottesville	Virginia
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	UC Health Department of Internal Medicine, Pulmonary, Critical Care & Sleep Medicine	Cincinnati	Ohio
United States	St. Francis Medical Institute - BTC - PPDS	Clearwater	Florida
United States	Cleveland Clinic	Cleveland	Ohio
United States	Pulmonary and Infections Disease Associates	Council Bluffs	Iowa
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Western Connecticut Medical Group	Danbury	Connecticut
United States	Henry Ford Health System	Dearborn	Michigan
United States	National Jewish Health	Denver	Colorado
United States	Western Washington Medical Group	Everett	Washington
United States	North Florida/South Georgia Veterans Health System-NAVREF-PPDS	Gainesville	Florida
United States	University of Florida	Gainesville	Florida
United States	PulmonIx LLC	Greensboro	North Carolina
United States	Penn State Milton S Hershey Medical Center	Hershey	Pennsylvania
United States	Houston Methodist Hospital	Houston	Texas
United States	Atria Clinical Research - BTC - PPDS	Little Rock	Arkansas
United States	David Geffen School of Medicine at UCLA	Los Angeles	California
United States	University of Louisville	Louisville	Kentucky
United States	Advanced Pulmonary Research Institute	Loxahatchee Groves	Florida
United States	University of Wisconsin	Madison	Wisconsin
United States	Metroplex Pulmonary and Sleep Medicine Center	McKinney	Texas
United States	Minnesota Lung Center	Minneapolis	Minnesota
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Tulane Medical Center	New Orleans	Louisiana
United States	Creighton University	Omaha	Nebraska
United States	Respire Research	Palm Springs	California
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Pulmonary Associates	Phoenix	Arizona
United States	The Oregon Clinic	Portland	Oregon
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Mayo Clinic - PPDS	Rochester	Minnesota
United States	University of Rochester Medical Center - PPDS	Rochester	New York
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	University of Utah Medical Care	Salt Lake City	Utah
United States	University of Texas Health Science Center San Antonio	San Antonio	Texas
United States	University of California San Diego	San Diego	California
United States	Mayo Clinic Arizona - PPDS	Scottsdale	Arizona
United States	University of Washington Medical Center	Seattle	Washington
United States	Stanford University Medical Center	Stanford	California
United States	MedStar Georgetown University Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Galapagos NV

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Brazil,  Chile,  Czechia,  Denmark,  Germany,  Greece,  Japan,  Peru,  Spain,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Annual Rate of Decline in 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 Week 52	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 hospitalization were reported in this measure.	Up to EoS (week 121)
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 in 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 121)
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 121)
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 121)
Secondary	Percentage of Participants With Respiratory Related Mortality Until EoS	Percentage of participants with respiratory related mortality until EoS were reported for this study.	Up to EoS (week 121)
Secondary	Percentage of Participants Hospitalized for Non-elective Lung Transplant Until EoS	Percentage of Participants who were hospitalized for Non-elective lung transplant were reported for this measure.	Up to EoS (week 121)
Secondary	Percentage of Participants With Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation Until EoS	Percentage of participants with acute IPF exacerbation until EoS were reported for this measure.	Up to EoS (week 121)
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 121)
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 non-elective lung transplant or hospitalization for qualifying for lung transplant were reported for this measure.	Up to EoS (week 121)
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 121)
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 121)
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 112	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 112
Secondary	Change From Baseline in FVC at Week 112	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 112
Secondary	Percent Change From Baseline in FVC at Week 112	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 112
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 112: 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 112
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 112: 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 112
Secondary	Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs	Safety was assessed by AEs, which included abnormalities identified during a medical test (example, 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 30 days after the last dose (up to week 121)
Secondary	Changes From Baseline Leicester Cough Questionnaire (LCQ) Total Score and Individual Domain Score at Week 52 and Week 100	Cough was evaluated using the LCQ. The LCQ was a 19-item questionnaire split into three domains: physical, psychological, and social. Scores were calculated by domain (range from 1 to 7, higher scores indicated a better health status) 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	Change 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	Change From Baseline in European Quality Of Life (EQ) VAS at Week 52 and Week 100	EuroQol outcome measurements is a printed 20 cm 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	Change From Baseline in King's Brief Interstitial Lung Disease (K-BILD) at Week 52 and Week 100	The K-BILD questionnaire was specifically developed to analyze the health status of participants with ILD. The questionnaire consists of 15 items (assessed by the participants on a scale ranging from 1 to 7, where 1 and 7 represent 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 (AUC) 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 Total Distance Walked in Six-minute Walk Test (6MWT) at Week 52 and Week 100	The 6-MWT depicted the total distance covered by a participant during 6 minutes of 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 DLCO (percent predicted hemoglobin level corrected) was reported for this measure.mmol/min/kPa: Millimole per minute per kilopascal	Baseline, week 52, week 100