Clinical Trials Logo

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
First received
Last updated
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
Health authority
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.

Study Design


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05984992 - The First-in-human Study of SRN-001 in Healthy Participants Phase 1
Active, not recruiting NCT04312594 - Study of Jaktinib Hydrochloride Tablets in Participants With Idiopathic Pulmonary Fibrosis Phase 2
Recruiting NCT03865927 - GKT137831 in IPF Patients With Idiopathic Pulmonary Fibrosis Phase 2
Completed NCT03979430 - Early Detection of Acute Exacerbation in Patients With Idiopathic Lung Fibrosis - a Pilot Study N/A
Enrolling by invitation NCT04905693 - Extension Study of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis Phase 3
Not yet recruiting NCT06241560 - A Study in People With Idiopathic Pulmonary Fibrosis to Test Whether Pirfenidone Influences the Amount of BI 1015550 in the Blood Phase 2
Terminated NCT04419558 - Zephyrus II: Efficacy and Safety Study of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF) Phase 3
Completed NCT03725852 - A Clinical Study to Test How Effective and Safe GLPG1205 is for Participants With Idiopathic Pulmonary Fibrosis (IPF) Phase 2
Terminated NCT03573505 - An Efficacy and Safety Study of BG00011 in Participants With Idiopathic Pulmonary Fibrosis Phase 2
Recruiting NCT04148157 - Quality of Life in IPF - Patient and Physician Perceptions
Completed NCT03222648 - Structured Exercise Training Programme in Idiopathic Pulmonary Fibrosis N/A
Not yet recruiting NCT06422884 - A Phase 2 Trial of ENV-101 in Patients With Lung Fibrosis (WHISTLE-PF Trial) Phase 2
Completed NCT02268981 - Effects of an Oxymizer® During Daytime in Patients With Pulmonary Fibrosis (IPF) N/A
Completed NCT02257177 - RCT (Randomized Control Trial) of TD139 vs Placebo in HV's (Human Volunteers) and IPF Patients Phase 1/Phase 2
Withdrawn NCT01524068 - A MultiCenter Study of Combined PEX, Rituximab, and Steroids in Acute Idiopathic Pulmonary Fibrosis Exacerbations Phase 2
Enrolling by invitation NCT01382368 - Acute Effect of Sildenafil on Exercise Tolerance and Functional Capacity in COPD, IPF and Post Pneumonectomy Patients Phase 4
Completed NCT01199887 - Trial Of IW001 in Patients With Idiopathic Pulmonary Fibrosis Phase 1
Completed NCT01110694 - Prospective Observation of Fibrosis in the Lung Clinical Endpoints Study
Active, not recruiting NCT02951416 - Clinical Course of Interstitial Lung Diseases: European IPF Registry and Biobank
Terminated NCT00981747 - Targeting Vascular Reactivity in Idiopathic Pulmonary Fibrosis Phase 2/Phase 3