Idiopathic Pulmonary FibrosisPhase 3ISABELA2NCT03733444
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
A Phase 3 study testing GLPG1690 in people with Idiopathic Pulmonary Fibrosis, run by Lakefront Biotherapeutics NV at 132 sites in 15 countries.
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). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- GLPG1690
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 781 participants
- Where
- 132 sitesin 15 countries
- Study dates
- 5 Nov 2018to 30 Mar 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
132 sites in 15 countries.
132 sites in 15 countries
United States36 sites
Albany Medical Center
Albany, New York, 12208
Lovelace Scientific Resources Inc
Albuquerque, New Mexico, 87108
University of Michigan Health System (UMHS)
Ann Arbor, Michigan, 48109
Piedmont Healthcare
Atlanta, Georgia, 30309
Emory University
Atlanta, Georgia, 30322
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Brigham and Womens Hospital
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
University of Vermont
Burlington, Vermont, 05401
Medical University of South Carolina - PPDS
Charleston, South Carolina, 29425
Cardio Pulmonary Associates
Chesterfield, Missouri, 63017
University of Chicago Medical Center
Chicago, Illinois, 60637
St. Francis Medical Institute
Clearwater, Florida, 33765
Ohio State University
Columbus, Ohio, 43203
Duke University Medical Center
Durham, North Carolina, 27710
Inova Fairfax Hospital
Falls Church, Virginia, 22042
Spectrum Health Medical Group
Grand Rapids, Michigan, 49546
University of Kansas Medical Center
Kansas City, Kansas, 66160
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03765
Keck School of Medicine of USC
Los Angeles, California, 90033
Cedars Sinai Medical Center
Los Angeles, California, 90048
Loyola University Medical Center
Maywood, Illinois, 60153
University of Miami
Miami, Florida, 33136
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
Columbia University Medical Center
New York, New York, 10032
Renstar Medical Research
Ocala, Florida, 34470
Central Florida Pulmonary Group PA
Orlando, Florida, 32803
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Temple Lung Center
Philadelphia, Pennsylvania, 19140
Arizona Pulmonary Specialists
Phoenix, Arizona, 85012
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
UC Davis Medical Center
Sacramento, California, 95816
University of California, San Francisco Medical Center
San Francisco, California, 94143
Atlantic Respiratory Institute
Summit, New Jersey, 07901
Mercy Health - St. Vincent Medical Center
Toledo, Ohio, 43608
University of Arizona College of Medicine
Tucson, Arizona, 85724
Japan21 sites
Juntendo University Hospital
Bunkyō City, 113-8431
National Hospital Organization Kyushu Medical Center
Fukuoka, 810-8563
Fukuoka University Hospital
Fukuoka, 814-0180
NHO Okinawa Hospital
Ginowan, 901-2214
Tenryu Hospital
Hamamatsu, Shizuoka, 434-8511
Hamamatsu University School of Medicine
Hamamatsu, 431-3192
National Hospital Organization Himeji Medical Center
Himeji, 670-8520
Hiroshima Prefectural Hospital
Hiroshima, 734-8530
Kobe City Medical Center General Hospital
Hyōgo, 650-0047
Saiseikai Kumamoto Hospital
Kumamoto, 861-4101
Nagasaki University Hospital
Nagasaki, 852-8102
Nagoya University Hospital
Nagoya, 466-8560
National Hospital Organization Ibarakihigashi National Hospital
Naka, Ibaraki, 319-1113
Japanese Red Cross Okayama Hospital
Okayama, 700-8607
National Hospital Organization Kinki-Chuo Chest Medical Center
Sakai, 591-8555
Tohoku Medical and Pharmaceutical Hospital
Sendai, 983-8512
Tosei General Hospital
Seto, 489-8642
Tokyo Medical University Hospital
Shinjuku-Ku, 160-0023
Tokushima University Hospital
Tokushima, 770-8503
Center Hospital of the National Center for Global Health and Medicine
Tokyo, 162-8655
Kanagawa Cardiovascular and Respiratory Center
Yokohama, 236-0051
Canada8 sites
South Health Campus
Calgary, T3M 1M4
Hôtel Dieu Du Centre Hospitalier de L'université de Montréal
Montreal, H2L 4M1
McGill University Health Centre Research Institute
Montreal, QC H3S 1Y9
Institut Universitaire de Cardiologie et de Pneumologie
Québec, G1V 4G5
Toronto General Hospital
Toronto, M5G 2N2
Vancouver General Hospital
Vancouver, V5Z 1M9
Pacific Lung Research Center
Vancouver, V6Z 1Y6
Dr Anil Dhar Professional Medicine Corporation
Windsor, N8W1L9
Poland8 sites
Centrum Medycyny Oddechowej Mroz sp. j.
Bialystok, 15-044
Uniwersyteckie Centrum Kliniczne - PPDS
Gdansk, 80-952
PULMAG Arkadiusz Brodowski, Grzegorz Gasior S. C.
Katowice, 40-753
SP ZOZ Szpital Uniwersytecki w Krakowie
Krakow, 31-153
GRAŻYNA JASIENIAK-PINIS ATOPIA Niepubliczny Zakład Opieki Zdrowotnej Poradnie Specjalistyczne
Krakow, 31-159
SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
Lodz, 90-153
ETG Lublin
Lublin, 20-314
ETG Warszawa
Warsaw, 02-777
Germany7 sites
Kliniken der Stadt Koln GmbH
Cologne, 51109
Ruhrlandklinik
Essen, 45239
Praxis Dr. med. Claus Keller
Frankfurt, 60389
Universitätsmedizin Greifswald Klinik und Poliklinik für Innere Medizin B
Greifswald, 17475
Pneumologisches Forschungsinstitut
Großhansdorf, 22927
Lungenfachklinik Immenhausen
Immenhausen, 34376
Krankenhaus Bethanien - Klinik für Pneumologie und Allergologie
Solingen, 42699
Argentina6 sites
Centro Médico Dra de Salvo
Buenos Aires, C1426ABP
Hospital Privado Centro Médico de Córdoba
Córdoba, X5016KEH
CEMER Centro Médico de Enfermedades Respiratorias
Florida, B1602DQD
Hospital Zonal Especializado de Agudos y Crónicos Dr. Antonio A. Cetrangolo
Luján, B6700CNR
Instituto de Investigaciones Clínicas Mar Del Plata
Mar del Plata, B7600FZN
Fundacion Scherbovsky
Mendoza, 5500
Israel6 sites
Barzilai Medical Center
Ashkelon, 78278
Lady Davis Carmel Medical Center
Haifa, 34362
Hadassah University Hospital Ein Kerem
Jerusalem, 91120
Meir Medical Center
Kfar Saba, 44281
Rabin Medical Center - PPDS
Petah Tikva, 49100
Kaplan Medical Center
Rehovot, 7661041
Italy6 sites
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi
Ancona, 60020
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
Catania, Sicily, 95123
Presidio Ospedaliero GB Morgagni L Pierantoni
Forlì, 47121
Ospedale S. Giuseppe Multimedica
Milan, 20123
Università Cattolica Del S Cuore
Roma, 00168
Azienda Ospedaliera Universitaria Senese
Siena, 53100
Netherlands6 sites
VU Medisch Centrum
Amsterdam, 1081 HV
OLVG locatie Oost
Amsterdam, 1091 AC
Martini Ziekenhuis
Groningen, 9700 RM
Zuyderland Medisch Centrum
Heerlen, 6419 PC
St. Antonius Ziekenhuis
Nieuwegein, 3425 CM
Erasmus MC
Rotterdam, 3015 GD
South Africa6 sites
Tygerberg Hospital
Cape Town, 7505
University of Cape Town Lung Institute (UCTLI)
Cape Town, 7700
Dr Ismail Abdullah Private Practice
Cape Town, 7764
Ethekwini Hospital
Durban, 4017
Gateway Private Hospital
Durban, 4091
Milpark Hospital
Johannesburg, 2193
South Korea6 sites
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, Gyeonggi-do, 420-767
Gachon University Gil Medical Center
Incheon, 405760
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
Asan Medical Center - PPDS
Seoul, 05505
Samsung Medical Center
Seoul, 135-170
Soon Chun Hyang University Hospital Seoul
Seoul, 140-743
France4 sites
Hôpital Nord AP-HM
Marseille, 13915
Centre Hospitalier Regional Universitaire Montpellier
Montpellier, 34295
Groupe Hospitalier Bichat Claude Bernard
Paris, 75018
CHU de Reims
Reims, 51092
Hungary4 sites
Semmelweis Egyetem
Budapest, 1125
Veszprem Megyei Tudogyogyintezet
Farkasgyepű, 8582
Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktató Kórház
Miskolc, 3529
Tüdőgyógyintézet Törökbálint
Törökbálint, 2045
Mexico4 sites
Centro de Investigación Medico Biologica y de Terapia Avanzada S.C.
Guadalajara, 44130
Instituto Nacional De Enfermedades (INER)
Mexico City, 14080
Hospital Universitatorio Dr. Jose Eleuterio González
Monterrey, 64460
Unidad de Investigación Clínica En Medicina SC
Monterrey, 64718
New Zealand4 sites
Greenlane Clinical Centre
Auckland, 1051
NZ Respiratory & Sleep Institute
Auckland, 1149
Christchurch Hospital
Christchurch, 8011
Waikato Hospital
Hamilton, 3204
About this study
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
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).
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- GLPG1690, Placebo
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLPG1690Drug
Also called ziritaxestat
GLPG1690, film-coated tablets for oral use.
PlaceboDrug
Matching placebo, film-coated tablets for oral use.
| Study group | Role | What they receive |
|---|---|---|
| GLPG1690, 600 milligrams (mg) | Experimental | Participants received GLPG1690 (ziritaxestat) 600 mg as film-coated tablet orally, once daily (mean treatment duration was 332.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason). Receives: Drug: GLPG1690 |
| GLPG1690, 200 mg | Experimental | Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet orally, once daily (mean treatment duration was 336.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason). Receives: Drug: GLPG1690 |
| Placebo | Experimental | Participants received GLPG1690 (ziritaxestat) matching placebo tablets orally, once daily (mean treatment duration was 346.2 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline up to week 52
Secondary outcomes (34)
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.
Measured: Up to week 52
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.
Measured: Up to EoS (week 125)
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.
Measured: Baseline, week 52
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.
Measured: Baseline up to EoS (week 125)
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.
Measured: Up to EoS (week 125)
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.
Measured: Baseline, week 100
Percentage of Participants With All Cause Hospitalization Until EoS
Percentage of participants with all cause hospitalization was reported for this measure.
Measured: Up to EoS (week 125)
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.
Measured: Up to EoS (week 125)
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.
Measured: Up to EoS (week 125)
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.
Measured: Up to EoS (week 125)
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.
Measured: Up to EoS (week 125)
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.
Measured: Up to EoS (week 125)
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.
Measured: Up to EoS (week 125)
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.
Measured: Up to EoS (week 125)
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.
Measured: Week 52
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.
Measured: Baseline, week 52
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.
Measured: Baseline, week 52
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.
Measured: Week 100
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.
Measured: Baseline, week 100
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.
Measured: Baseline, week 100
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.
Measured: Baseline, week 52
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.
Measured: Baseline, week 100
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.
Measured: Baseline, week 52
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.
Measured: Baseline, week 100
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.
Measured: Baseline up to EoS (up to Week 125)
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.
Measured: Baseline, week 52, week 100
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).
Measured: Baseline, week 52, week 100
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).
Measured: Baseline, week 52, week 100
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.
Measured: Baseline, week 52, week 100
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).
Measured: Baseline, week 52, week 100
Area Under The Concentration Time Curve of Ziritaxtestat
Area under the concentration time curve of ziritaxtestat was reported
Measured: Sparse samples collected on day 1 pre-dose, day 85 post-dose, day 237 post-dose, day 183 pre-dose, day 365 pre-dose
Maximum Observed Plasma Concentration (Cmax) of Ziritaxtestat
Maximum Observed Plasma Concentration of Ziritaxtestat was reported.
Measured: Sparse samples collected on day 1 pre-dose, day 85 post-dose, day 237 post-dose, day 183 pre-dose, day 365 pre-dose
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.
Measured: Baseline, week 52, week 100
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
Measured: Baseline, week 52 and week 100
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start5 Nov 2018
- Primary completion30 Mar 2021
- Study completion30 Mar 2021
Why it stopped: The benefit-risk profile no longer supports continuing the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 781 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lakefront Biotherapeutics NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Galapagos Study Director, Study director, Lakefront Biotherapeutics NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03733444
- Sponsor's protocol ID
- GLPG1690-CL-304
- Other IDs
- 2018-001406-29, 2018
- Acronym
- ISABELA2
- Status last verified
- Jul 2022
- First submitted
- 5 Nov 2018
- Last updated
- 29 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ford P, Kreuter M, Brown KK, Wuyts WA, Wijsenbeek M, Israel-Biet D, Hubbard R, Nathan SD, Nunes H, Penninckx B, Prasad N, Seghers I, Spagnolo P, Verbruggen N, Hirani N, Behr J, Kaner RJ, Maher TM. An adjudication algorithm for respiratory-related hospitalisation in idiopathic pulmonary fibrosis. ERJ Open Res. 2024 Jan 29;10(1):00636-2023. doi: 10.1183/23120541.00636-2023. eCollection 2024 Jan.
PubMed 38288082Maher TM, Ford P, Brown KK, Costabel U, Cottin V, Danoff SK, Groenveld I, Helmer E, Jenkins RG, Milner J, Molenberghs G, Penninckx B, Randall MJ, Van Den Blink B, Fieuw A, Vandenrijn C, Rocak S, Seghers I, Shao L, Taneja A, Jentsch G, Watkins TR, Wuyts WA, Kreuter M, Verbruggen N, Prasad N, Wijsenbeek MS; ISABELA 1 and 2 Investigators. Ziritaxestat, a Novel Autotaxin Inhibitor, and Lung Function in Idiopathic Pulmonary Fibrosis: The ISABELA 1 and 2 Randomized Clinical Trials. JAMA. 2023 May 9;329(18):1567-1578. doi: 10.1001/jama.2023.5355.
PubMed 37159034Deng X, Salgado-Polo F, Shao T, Xiao Z, Van R, Chen J, Rong J, Haider A, Shao Y, Josephson L, Perrakis A, Liang SH. Imaging Autotaxin In Vivo with 18F-Labeled Positron Emission Tomography Ligands. J Med Chem. 2021 Oct 28;64(20):15053-15068. doi: 10.1021/acs.jmedchem.1c00913. Epub 2021 Oct 18.
PubMed 34662125Maher TM, Kreuter M, Lederer DJ, Brown KK, Wuyts W, Verbruggen N, Stutvoet S, Fieuw A, Ford P, Abi-Saab W, Wijsenbeek M. Rationale, design and objectives of two phase III, randomised, placebo-controlled studies of GLPG1690, a novel autotaxin inhibitor, in idiopathic pulmonary fibrosis (ISABELA 1 and 2). BMJ Open Respir Res. 2019 May 21;6(1):e000422. doi: 10.1136/bmjresp-2019-000422. eCollection 2019.
PubMed 31179008
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03733444
- Acronym / sponsor ID
- ISABELA2 / GLPG1690-CL-304
- Conditions
- Idiopathic Pulmonary Fibrosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The benefit-risk profile no longer supports continuing the study
- Enrolment
- 781 participants (actual)
- Lead sponsor
- Lakefront Biotherapeutics NVIndustry (pharma, biotech, devices)
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 7 Nov 2018 (actual)
- Results
- Posted 29 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GLPG1690, 600 milligrams (mg) | Experimental | Drug: GLPG1690Participants received GLPG1690 (ziritaxestat) 600 mg as film-coated tablet orally, once daily (mean treatment duration was 332.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason). |
| GLPG1690, 200 mg | Experimental | Drug: GLPG1690Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet orally, once daily (mean treatment duration was 336.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason). |
| Placebo | Experimental | Drug: PlaceboParticipants received GLPG1690 (ziritaxestat) matching placebo tablets orally, once daily (mean treatment duration was 346.2 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason). |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GLPG1690Also: ziritaxestatGLPG1690, film-coated tablets for oral use. | Drug | GLPG1690, 200 mg, GLPG1690, 600 milligrams (mg) |
| PlaceboMatching placebo, film-coated tablets for oral use. | Drug | Placebo |
Primary outcome
Annual Rate of Decline in Forced Vital Capacity (FVC) up to Week 52
Time frame: Baseline 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.
34 secondary outcomes
Percentage of Participants With Disease Progression Up to 52 Weeks
Time frame: Up to week 52
Percentage of Participants With Respiratory-Related Hospitalization Until End of Study (EoS)
Time frame: Up to EoS (week 125)
Change From Baseline in St.George's Respiratory Questionnaire (SGRQ) Total Score at Week 52
Time frame: Baseline, week 52
Annual Rate of Decline of FVC Until EoS
Time frame: Baseline up to EoS (week 125)
Percentage of Participants With Disease Progression Until EoS
Time frame: Up to EoS (week 125)
Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 100
Time frame: Baseline, week 100
Percentage of Participants With All Cause Hospitalization Until EoS
Time frame: Up to EoS (week 125)
Percentage of Participants With Respiratory Related Mortality Until EoS
Time frame: Up to EoS (week 125)
Percentage of Participants Hospitalized for Non-Elective Lung Transplant Until EoS
Time frame: Up to EoS (week 125)
Percentage of Participants With Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation Until EoS
Time frame: Up to EoS (week 125)
Percentage of Participants With All Cause Mortality or Hospitalization for Non-elective Lung Transplant Until EoS
Time frame: Up to EoS (week 125)
Percentage of Participants With All Cause Mortality, Hospitalization for Non-elective Lung Transplant or Hospitalization for Qualifying for Lung Transplant Until EoS
Time frame: Up to EoS (week 125)
Percentage of Participants With All-Cause Mortality or Hospitalization That Meets >=10% Absolute Decline in %FVC or Respiratory-Related Hospitalization Until EoS
Time frame: Up to EoS (week 125)
Percentage of Participants With All-Cause Mortality or Respiratory-Related Hospitalizations Until EoS
Time frame: Up to EoS (week 125)
FVC at Week 52
Time frame: Week 52
Change From Baseline in FVC at Week 52
Time frame: Baseline, week 52
Percent Change From Baseline in FVC at Week 52
Time frame: Baseline, week 52
FVC at Week 100
Time frame: Week 100
Change From Baseline in FVC at Week 100
Time frame: Baseline, week 100
Percent Change From Baseline in FVC at Week 100
Time frame: Baseline, week 100
Percentage of Participants With Absolute Categorical Change From Baseline in Percent FVC at Week 52: FVC Change Within ≤5
Time frame: Baseline, week 52
Percentage of Participants With Absolute Categorical Change From Baseline in Percent FVC at Week 100: FVC Change Within ≤5
Time frame: Baseline, week 100
Percentage of Participants With Absolute Categorical Change From Baseline in Percent FVC at Week 52: FVC Change Within ≤10
Time frame: Baseline, week 52
Percentage of Participants With Absolute Categorical Change From Baseline in Percent FVC at Week 100: FVC Change Within ≤10
Time frame: Baseline, week 100
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
Time frame: Baseline up to EoS (up to Week 125)
Changes From Baseline in Leicester Cough Questionnaire (LCQ) Total Score and Individual Domain Score at Week 52 and Week 100
Time frame: Baseline, week 52, week 100
Changes From Baseline in Visual Analogue Score (VAS): Cough at Week 52 and Week 100
Time frame: Baseline, week 52, week 100
Change From Baseline in Visual Analogue Score (VAS): Urge to Cough at Week 52 and Week 100
Time frame: Baseline, week 52, week 100
Changes From Baseline in EuroQOL 5-Dimensions Questionnaire at Week 52 and Week 100
Time frame: Baseline, week 52, week 100
Changes From Baseline in King's Brief Interstitial Lung Disease (K-BILD) at Week 52 and Week 100
Time frame: Baseline, week 52, week 100
Area Under The Concentration Time Curve of Ziritaxtestat
Time frame: Sparse samples collected on day 1 pre-dose, day 85 post-dose, day 237 post-dose, day 183 pre-dose, day 365 pre-dose
Maximum Observed Plasma Concentration (Cmax) of Ziritaxtestat
Time frame: Sparse samples collected on day 1 pre-dose, day 85 post-dose, day 237 post-dose, day 183 pre-dose, day 365 pre-dose
Change From Baseline in Functional Exercise Capacity, Assessed by The 6-Minute Walk Test (6MWT) Distance, at Week 52 and Week 100
Time frame: Baseline, week 52, week 100
Change From Baseline in Diffusing Capacity of Lung for Carbon Monoxide (DLCO) (Corrected for Hemoglobin [Hb]) at Week 52 and Week 100
Time frame: Baseline, week 52 and week 100
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38288082Ford P, Kreuter M, Brown KK, Wuyts WA, Wijsenbeek M, Israel-Biet D, Hubbard R, Nathan SD, Nunes H, Penninckx B, Prasad N, Seghers I, Spagnolo P, Verbruggen N, Hirani N, Behr J, Kaner RJ, Maher TM. An adjudication algorithm for respiratory-related hospitalisation in idiopathic pulmonary fibrosis. ERJ Open Res. 2024 Jan 29;10(1):00636-2023. doi: 10.1183/23120541.00636-2023. eCollection 2024 Jan.
- Derived from this study: PubMed 37159034Maher TM, Ford P, Brown KK, Costabel U, Cottin V, Danoff SK, Groenveld I, Helmer E, Jenkins RG, Milner J, Molenberghs G, Penninckx B, Randall MJ, Van Den Blink B, Fieuw A, Vandenrijn C, Rocak S, Seghers I, Shao L, Taneja A, Jentsch G, Watkins TR, Wuyts WA, Kreuter M, Verbruggen N, Prasad N, Wijsenbeek MS; ISABELA 1 and 2 Investigators. Ziritaxestat, a Novel Autotaxin Inhibitor, and Lung Function in Idiopathic Pulmonary Fibrosis: The ISABELA 1 and 2 Randomized Clinical Trials. JAMA. 2023 May 9;329(18):1567-1578. doi: 10.1001/jama.2023.5355.
- Derived from this study: PubMed 34662125Deng X, Salgado-Polo F, Shao T, Xiao Z, Van R, Chen J, Rong J, Haider A, Shao Y, Josephson L, Perrakis A, Liang SH. Imaging Autotaxin In Vivo with 18F-Labeled Positron Emission Tomography Ligands. J Med Chem. 2021 Oct 28;64(20):15053-15068. doi: 10.1021/acs.jmedchem.1c00913. Epub 2021 Oct 18.
- Derived from this study: PubMed 31179008Maher TM, Kreuter M, Lederer DJ, Brown KK, Wuyts W, Verbruggen N, Stutvoet S, Fieuw A, Ford P, Abi-Saab W, Wijsenbeek M. Rationale, design and objectives of two phase III, randomised, placebo-controlled studies of GLPG1690, a novel autotaxin inhibitor, in idiopathic pulmonary fibrosis (ISABELA 1 and 2). BMJ Open Respir Res. 2019 May 21;6(1):e000422. doi: 10.1136/bmjresp-2019-000422. eCollection 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Galapagos Study Director study director
Lakefront Biotherapeutics NV
132 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GLPG1690 in people with Idiopathic Pulmonary Fibrosis, run by Lakefront Biotherapeutics NV at 132 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 132 sites in United States, Japan, Canada, Poland, Germany and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annual Rate of Decline in Forced Vital Capacity (FVC) up to Week 52 (time frame: Baseline up to week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03733444, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2022; AzTrials last refreshed its copy on 30 Oct 2026.