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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-004302-18 | EudraCT Number |
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This is a randomized, double-blind, parallel-group, placebo-controlled, multicenter, exploratory Phase 2 study including participants with Idiopathic Pulmonary Fibrosis (IPF), investigating GLPG1205 in addition to the local standard of care (defined as receiving nintedanib, pirfenidone, or neither nintedanib nor pirfenidone).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLPG1205 100 mg | Experimental | Participants will receive GLPG1205 100 milligrams (mg) (2 capsules x 50 mg), orally once daily for 26 weeks in addition to the local standard of care. Standard of care includes nintedanib, pirfenidone, or neither nintedanib nor pirfenidone. |
|
| Placebo | Placebo Comparator | Participants will receive GLPG1205 matching placebo, orally once daily (as 2 capsules) for 26 weeks in addition to the local standard of care. Standard of care includes nintedanib, pirfenidone, or neither nintedanib nor pirfenidone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLPG1205 | Drug | GLPG1205 will be provided as an oral hard gelatin capsule. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Forced Vital Capacity (FVC) at Week 26 | Forced vital capacity (FVC) (in milliliter [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 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Related to Study Drug, and TEAEs Leading to Study Drug Discontinuation | An adverse event (AE) was any untoward medical occurrence in a participant administered study drug and which did not necessarily have a causal relationship with study drug. A TEAE was any AE with an onset date on or after the start of study drug intake and no later than 30 days after last dose of study drug, or any worsening of any AE on or after the start of study drug intake. A serious AE was defined as an AE that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was medically significant. |
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Inclusion criteria:
Participants who meet all of the following criteria are eligible for the study:
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) guideline. Participants receiving local standard of care for the treatment of IPF, defined as either pirfenidone or nintedanib at a stable dose for at least 8 weeks before screening, and during screening; or neither pirfenidone nor nintedanib (for any reason). A stable dose is defined as the highest tolerated dose. Prednisone at steady dose less than or equal to 10 mg/day or equivalent glucocorticoid dose is allowed (stabilized 4 weeks prior to screening and continued without variation of dose or regimen). Supportive care like supplemental oxygen or pulmonary rehabilitation is allowed.
Meeting all of the following criteria at screening and during the screening period:
In a stable condition and suitable for study participation based on the results of a medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and laboratory evaluation. Stable condition is based on the clinical judgment of the investigator, co-morbidities should be treated according to the local applicable guidelines. Concomitant medication for chronic comorbidities should be stabilized from 4 weeks before screening and during the screening period (stable defined as no clinically relevant change according to the investigator's judgement).
Able to walk at least 150 meters during the 6 Minute Walk Test (6MWT) at screening; without having a contraindication to perform the 6MWT.
This list only describes the key inclusion criteria.
Exclusion criteria:
Participants meeting one or more of the following criteria cannot be selected for this study:
This list only describes the key exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Christian Seemayer, MD | Lakefront Biotherapeutics NV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Specialized Hospital for Active Treatment Pleven | Pleven | 5800 | Bulgaria | |||
| SHATPPD Dr. Dimitar Gramatikov, Ruse Ltd. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Strambu IR, Fagard L, Ford P, Van Der Aa T, De Haas-Amatsaleh A, Santermans E, Seemayer C. (2020). Idiopathic pulmonary fibrosis (IPF): observations from a Phase 2 trial of GLPG1205 (PINTA). Abstract for European Respiratory Society International Congress 7-9 September 2020. | ||
| 36328358 | Derived | Strambu IR, Seemayer CA, Fagard LMA, Ford PA, Van der Aa TAK, de Haas-Amatsaleh AA, Modgill V, Santermans E, Sondag EN, Helmer EG, Maher TM, Costabel U, Cottin V. GLPG1205 for idiopathic pulmonary fibrosis: a phase 2 randomised placebo-controlled trial. Eur Respir J. 2023 Mar 2;61(3):2201794. doi: 10.1183/13993003.01794-2022. Print 2023 Mar. |
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A total of 155 participants were screened, of which 86 participants were considered ineligible. Out of 69 enrolled participants, 1 participant met an exclusion criterion pre-dose and was therefore excluded.
Participants were enrolled at study sites in Bulgaria, Croatia, Finland, France, Oman, Romania, Slovakia, Sweden, and Ukraine. The first participant was screened on 27 Sep 2018. The last study visit occurred on 14 Aug 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | GLPG1205 100 mg | Participants received GLPG1205 100 milligrams (mg) (2 capsules x 50 mg), orally once daily for 26 weeks in addition to the local standard of care. Standard of care included nintedanib, pirfenidone, or neither nintedanib nor pirfenidone. |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 30, 2020 | Jun 24, 2021 |
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| Placebo |
| Drug |
GLPG1205 matching placebo will be provided as an oral hard gelatin capsule. |
|
| First dose date up to 30 days after the last dose of study drug (maximum up to 263 days) |
| Time to Any Major Events Depicted by Cumulative Percentage of Participants With All-cause Deaths, Respiratory-related Deaths, All-cause Hospitalizations, and Respiratory-related Hospitalizations | Treatment effect on time to death (all-cause and respiratory-related)/hospitalization (all-cause and respiratory-related) were assessed using the log-rank test. Kaplan-Meier estimates were derived for the probability of death (all-cause and respiratory-related)/hospitalization (all-cause and respiratory-related). Cumulative percentage of participants with all-cause deaths, respiratory-related deaths, all-cause hospitalizations, and respiratory-related hospitalizations were reported. | Day 1 up to Week 30 |
| Change From Baseline in Total Distance Walked in Six-minute Walk Test (6MWT) at Week 26 | The 6-MWT depicts the total distance covered by a participant during 6 minutes of walking. | Baseline, Week 26 |
| Change From Baseline in St.George's Respiratory Questionnaire (SGRQ) Total Score at Week 26 | The 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 (assessing the frequency and severity of respiratory symptoms), activity (assessing the effects of breathlessness on mobility and physical activity), and impact (assessing the psychosocial impact of the disease). Scores were weighted such that each domain score and the total score ranged from 0 to 100, with higher scores indicating the poorer health-related QOL. | Baseline, Week 26 |
| Change From Baseline in SGRQ Domain Score at Week 26 | The SGRQ is a 50-item paper questionnaire designed to measure and quantify the impact of chronic respiratory disease on health-related QOL and well-being, split into 3 domains: symptoms (assessing the frequency and severity of respiratory symptoms), activity (assessing the effects of breathlessness on mobility and physical activity), and impact (assessing the psychosocial impact of the disease). Scores were weighted such that each domain score ranged from 0 to 100, with higher scores indicating the poorer health-related QOL. | Baseline, Week 26 |
| Percentage of SGRQ Responders | The SGRQ is a 50-item paper questionnaire designed to measure and quantify the impact of chronic respiratory disease on health-related QOL and well-being, split into 3 domains: symptoms (assessing the frequency and severity of respiratory symptoms), activity (assessing the effects of breathlessness on mobility and physical activity), and impact (assessing the psychosocial impact of the disease). Scores were weighted such that each domain score and total score ranged from 0 to 100, with higher scores indicating the poorer health-related QOL. SGRQ responders are those with absolute change from baseline in SGRQ total score less than or equal to -4 percent (%) at least once. | Baseline up to Week 26 |
| Pre-dose Plasma Concentration (Ctrough) of GLPG1205 at Week 26 | GLPG1205 pre-dose plasma concentration (Ctrough) at Week 26 was reported applying the exclusion rules (e.g. dose reduction, discontinuation, samples flagged). | Week 26 (pre-dose) |
| Pre-dose Plasma Concentration (Ctrough) of Nintedanib at Week 20 | Nintedanib pre-dose plasma concentration (Ctrough) at Week 20 was reported applying the exclusion rules (e.g. dose reduction, discontinuation, samples flagged). | Week 20 (pre-dose) |
| Pre-dose Plasma Concentration (Ctrough) of Pirfenidone at Week 20 | Pirfenidone pre-dose plasma concentration (Ctrough) at Week 20 was reported applying the exclusion rules (e.g. dose reduction, discontinuation, samples flagged). | Week 20 (pre-dose) |
| Rousse |
| 7002 |
| Bulgaria |
| Acibadem City Clinic Tokuda Hospital, EAD | Sofia | Bulgaria |
| Klinicki Bolnicki Centar Rijeka - Susak | Rijeka | 51000 | Croatia |
| Klinička Bolnica Dubrava | Zagreb | Croatia |
| Klinički Bolnički Centar Zagreb - Klinika Za Plućne Bolesti Jordanovac | Zagreb | Croatia |
| Helsinki University Hospital Heart and Lung Center | Helsinki | 00290 | Finland |
| Tampere University Hospital | Tampere | 33521 | Finland |
| Hôpital Avicenne | Bobigny | France |
| CHU de Brest - Hôpital Cavale Blanche | Brest | France |
| CHU de Lyon - Hôpital Louis Pradel | Bron | France |
| CHU de Grenoble | La Tronche | France |
| Hôpital Albert Calmette | Lille | 59037 | France |
| CHU de Nice - Hôpital Pasteur | Nice | France |
| Hôpital Européen Georges Pompidou (HEGP) | Paris | France |
| Hôpital Larrey | Toulouse | France |
| CHRU de Tours - Hôpital Bretonneau | Tours | France |
| Hôpitaux Prives de Metz (HPMetz) - Hôpital Robert Schuman | Vantoux | France |
| National Oncology Centre - The Royal Hospital Muscat | Muscat | Oman |
| Institutul de Pneumoftiziologie Marius Nasta | Bucharest | 50159 | Romania |
| Spitalul Clinic De Pneumoftiziologie Leon Daniello Cluj-Napoca | Cluj-Napoca | 400371 | Romania |
| Spitalul Clinic de Pneumoftiziologie Iasi | Iași | 700115 | Romania |
| Clinica Medicala Lavinia Davidescu | Oradea | 410169 | Romania |
| ZAPA JJ s.r.o. | Levice | 934 01 | Slovakia |
| Pľúcna Ambulancia Hrebenár, s.r.o. | Spišská Nová Ves | 05201 | Slovakia |
| National Institute of Tuberculosis, Pulmonary Diseases and Chest Surgery | Vyšné Hágy | 059 84 | Slovakia |
| Universitetssjukhuset i Lund | Lund | 22185 | Sweden |
| Karolinska Universitetssjukhuset | Stockholm | Sweden |
| Akademiska Sjukhuset - Uppsala Centrum for Cystisk Fibros | Uppsala | Sweden |
| Dnipropetrovsk State Medical Academy - Dnipropetrovsk City Clinical Hospital No. 6 | Dnipropetrovsk | 49074 | Ukraine |
| The Ivano-Frankivsk National Medical Univeristy | Ivano-Frankivsk | Ukraine |
| Communal Nonprofit Enterprise City Clinical Hospital | Kharkiv | Ukraine |
| Municipal Institution "Kherson city clinical hospital named after E.E. Karabelesh" | Kherson | Ukraine |
| National Institute of Phthisiology and Pulmonology named after F.G. Yanovskyi of NAMS of Ukraine | Kyiv | 3680 | Ukraine |
| Odessa Regional Hospital | Odesa | Ukraine |
| Vinnitsa Regional Clinical Hospital im. N.I. Pirogov | Vinnytsia | Ukraine |
Participants received GLPG1205 matching placebo, orally once daily (as 2 capsules) for 26 weeks in addition to the local standard of care. Standard of care included nintedanib, pirfenidone, or neither nintedanib nor pirfenidone. |
| COMPLETED |
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| NOT COMPLETED |
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Full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | GLPG1205 100 mg | Participants received GLPG1205 100 mg (2 capsules x 50 mg), orally once daily for 26 weeks in addition to the local standard of care. Standard of care included nintedanib, pirfenidone, or neither nintedanib nor pirfenidone. |
| BG001 | Placebo | Participants received GLPG1205 matching placebo, orally once daily (as 2 capsules) for 26 weeks in addition to the local standard of care. Standard of care included nintedanib, pirfenidone, or neither nintedanib nor pirfenidone. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Forced Vital Capacity (FVC) at Week 26 | Forced vital capacity (FVC) (in milliliter [mL]) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry. | Participants in the full analysis set (FAS) (consisted of all randomized participants who received at least 1 dose of the study drug) with available data were analyzed. | Posted | Mean | Standard Error | mL | Baseline, Week 26 |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Related to Study Drug, and TEAEs Leading to Study Drug Discontinuation | An adverse event (AE) was any untoward medical occurrence in a participant administered study drug and which did not necessarily have a causal relationship with study drug. A TEAE was any AE with an onset date on or after the start of study drug intake and no later than 30 days after last dose of study drug, or any worsening of any AE on or after the start of study drug intake. A serious AE was defined as an AE that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was medically significant. | Participants in the FAS population were analyzed. | Posted | Number | participants | First dose date up to 30 days after the last dose of study drug (maximum up to 263 days) |
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| Secondary | Time to Any Major Events Depicted by Cumulative Percentage of Participants With All-cause Deaths, Respiratory-related Deaths, All-cause Hospitalizations, and Respiratory-related Hospitalizations | Treatment effect on time to death (all-cause and respiratory-related)/hospitalization (all-cause and respiratory-related) were assessed using the log-rank test. Kaplan-Meier estimates were derived for the probability of death (all-cause and respiratory-related)/hospitalization (all-cause and respiratory-related). Cumulative percentage of participants with all-cause deaths, respiratory-related deaths, all-cause hospitalizations, and respiratory-related hospitalizations were reported. | Participants in the FAS population were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 1 up to Week 30 |
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| Secondary | Change From Baseline in Total Distance Walked in Six-minute Walk Test (6MWT) at Week 26 | The 6-MWT depicts the total distance covered by a participant during 6 minutes of walking. | Participants in the FAS population with available data were analyzed. | Posted | Mean | Standard Error | meters | Baseline, Week 26 |
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| Secondary | Change From Baseline in St.George's Respiratory Questionnaire (SGRQ) Total Score at Week 26 | The 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 (assessing the frequency and severity of respiratory symptoms), activity (assessing the effects of breathlessness on mobility and physical activity), and impact (assessing the psychosocial impact of the disease). Scores were weighted such that each domain score and the total score ranged from 0 to 100, with higher scores indicating the poorer health-related QOL. | Participants in the FAS population with available data were analyzed. | Posted | Mean | Standard Error | units on a scale | Baseline, Week 26 |
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| Secondary | Change From Baseline in SGRQ Domain Score at Week 26 | The SGRQ is a 50-item paper questionnaire designed to measure and quantify the impact of chronic respiratory disease on health-related QOL and well-being, split into 3 domains: symptoms (assessing the frequency and severity of respiratory symptoms), activity (assessing the effects of breathlessness on mobility and physical activity), and impact (assessing the psychosocial impact of the disease). Scores were weighted such that each domain score ranged from 0 to 100, with higher scores indicating the poorer health-related QOL. | Participants in the FAS population with available data were analyzed. | Posted | Mean | Standard Error | units on a scale | Baseline, Week 26 |
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| Secondary | Percentage of SGRQ Responders | The SGRQ is a 50-item paper questionnaire designed to measure and quantify the impact of chronic respiratory disease on health-related QOL and well-being, split into 3 domains: symptoms (assessing the frequency and severity of respiratory symptoms), activity (assessing the effects of breathlessness on mobility and physical activity), and impact (assessing the psychosocial impact of the disease). Scores were weighted such that each domain score and total score ranged from 0 to 100, with higher scores indicating the poorer health-related QOL. SGRQ responders are those with absolute change from baseline in SGRQ total score less than or equal to -4 percent (%) at least once. | Participants in the FAS population with available data were analyzed. | Posted | Number | percentage of participants | Baseline up to Week 26 |
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| Secondary | Pre-dose Plasma Concentration (Ctrough) of GLPG1205 at Week 26 | GLPG1205 pre-dose plasma concentration (Ctrough) at Week 26 was reported applying the exclusion rules (e.g. dose reduction, discontinuation, samples flagged). | Participants in the pharmacokinetic (PK) analysis set (a subset of the FAS, including all participants who had available and evaluable plasma concentration data, excluding all protocol deviations or AEs that may have had an impact on the PK analysis) with available data were analyzed. | Posted | Mean | Standard Deviation | nanograms per milliliter (ng/mL) | Week 26 (pre-dose) |
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| Secondary | Pre-dose Plasma Concentration (Ctrough) of Nintedanib at Week 20 | Nintedanib pre-dose plasma concentration (Ctrough) at Week 20 was reported applying the exclusion rules (e.g. dose reduction, discontinuation, samples flagged). | Participants in the PK analysis set with available data were analyzed. | Posted | Mean | Standard Deviation | ng/mL | Week 20 (pre-dose) |
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| Secondary | Pre-dose Plasma Concentration (Ctrough) of Pirfenidone at Week 20 | Pirfenidone pre-dose plasma concentration (Ctrough) at Week 20 was reported applying the exclusion rules (e.g. dose reduction, discontinuation, samples flagged). | Participants in the PK analysis set with available data were analyzed. | Posted | Mean | Standard Deviation | ng/mL | Week 20 (pre-dose) |
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First dose date up to 30 days after the last dose of study drug (maximum up to 263 days)
Full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GLPG1205 100 mg | Participants received GLPG1205 100 mg (2 capsules x 50 mg), orally once daily for 26 weeks in addition to the local standard of care. Standard of care included nintedanib, pirfenidone, or neither nintedanib nor pirfenidone. | 1 | 45 | 9 | 45 | 36 | 45 |
| EG001 | Placebo | Participants received GLPG1205 matching placebo, orally once daily (as 2 capsules) for 26 weeks in addition to the local standard of care. Standard of care included nintedanib, pirfenidone, or neither nintedanib nor pirfenidone. | 0 | 23 | 1 | 23 | 18 | 23 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
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| Gastrointestinal viral infection | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
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| Post procedural infection | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Normocytic anaemia | Blood and lymphatic system disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 23.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Chronic gastritis | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Mucous stools | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Diarrhoea infectious | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Erythema migrans | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Gastrointestinal viral infection | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Gingival abscess | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Kidney infection | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Oral fungal infection | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Tracheitis | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Burning sensation | Nervous system disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Dyskinesia | Nervous system disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Parkinson's disease | Nervous system disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Hunger | General disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Thirst | General disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Brain natriuretic peptide increased | Investigations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Neutrophil count increased | Investigations | MedDRA Version 23.0 | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Appetite disorder | Metabolism and nutrition disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Papule | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Neutrophilia | Blood and lymphatic system disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Immune thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Normocytic anaemia | Blood and lymphatic system disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Hepatic mass | Hepatobiliary disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Hepatic steatosis | Hepatobiliary disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Systematic Assessment |
| |
| Polyuria | Renal and urinary disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Renal pain | Renal and urinary disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Panophthalmitis | Eye disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Tooth extraction | Surgical and medical procedures | MedDRA Version 23.0 | Systematic Assessment |
|
The study was not powered to detect statistical significance and was limited by its small sample size, high variability of the primary endpoint (FVC), and a high rate of early treatment discontinuations.
The sponsor must review and approve any results of the study or abstracts for professional meetings prepared by the investigator(s). Published data must not compromise the objectives of the study. Data from individual study centers in multicenter studies must not be published separately.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Galapagos Medical Information | Galapagos NV | +32 15 342 900 | medicalinfo@glpg.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 4, 2020 | Jun 24, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000722907 | GLPG1205 |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Change at Week 26 |
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