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| Name | Class |
|---|---|
| Cystic Fibrosis Foundation | OTHER |
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This is a Phase 2 multicenter, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of lenabasum for the treatment of cystic fibrosis in patients 12 years of age or older. Approximately 415 subjects will be enrolled in this study at about 100 sites in North America, and Europe. The planned duration of treatment with study drug is 28 weeks.
Study drug will be lenabasum 20 mg BID, lenabasum 5 mg BID, and placebo in a 2:1:2 ratio.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lenabasum 20 mg BID | Experimental |
| |
| Lenabasum 5 mg BID | Experimental |
| |
| Placebo BID | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lenabasum 20 mg | Drug | Subjects will receive lenabasum 20 mg twice daily. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary Exacerbation (PEx) Rate Over 28 Weeks | Rate of PEx using the primary PEx definition with lenabasum 20 mg BID compared to placebo, during the treatment period. An primary PEx is defined on the physician's decision to treat with oral, intraveneous or inhaled antibiotics in the presence 4/12 Fuch's criteria (Change in sputum, new/increased hemoptysis, increased cough, increased dyspnea, malaise, fatigue/lethargy, Temperature greater than 38C, weight loss, sinus pain, change in sinus discharge, change in exam of chest, decrease in FEV1 of more than 10%, radiographic change). This excludes prophylactic antibiotics. A new PEx is a one that occurs at 28 days after the previous PEx. | 28 weeks (Baseline Day 0 to Week 28) |
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary Exacerbation (PEx) Rate | Event rate of PEx using the secondary PEx definition with lenabasum 20 mg BID compared to placebo. The secondary definition of a PEx is based on the physician's diagnosis of pulmonary exacerbation and commencement of new oral, intravenous, or inhaled antibiotics. A new PEx is defined one that starts 28 or more days after the previous confirmed PEx. The PEx rate is calculated as the number of PEx/28 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Severe or unstable CF at screening or Visit 1.
Any of the following values for laboratory tests at screening:
Any medical condition or concurrent medical therapies at screening or Visit 1 that may put the subject at greater safety risk, influence response to study drug or interfere with study assessments.
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| Name | Affiliation | Role |
|---|---|---|
| James Chmiel, MD | Indiana University School of Medicine/Riley Physicians Pulmonary | Principal Investigator |
| J. Stuart Elborn, MD | National Heart and Lung Institute, Imperial College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Children's Hospital | Phoenix | Arizona | 85016 | United States | ||
| University of Arkansas for Medical Sciences |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lenabasum 20 mg BID | Lenabasum 20 mg: Subjects will receive lenabasum 20 mg twice daily. |
| FG001 | Lenabasum 5 mg BID | Lenabasum 5 mg: Subjects will receive lenabasum 5 mg twice daily. |
| 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 | Nov 5, 2019 | Apr 5, 2022 |
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Multicenter, double-blind, randomized, placebo-controlled, parallel group study.
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| Lenabasum 5 mg |
| Drug |
Subjects will receive lenabasum 5 mg twice daily. |
|
| Placebo | Other | Subjects will receive placebo twice daily. |
|
| 28 weeks (Baseline Day 0 to Week 28) |
| Time to First New Pulmonary Exacerbation (PEx) | Time to first new PEx using the primary PEx definition with lenabasum 20 mg BID compared to placebo. An primary PEx is defined on the physician's decision to treat with oral, intraveneous or inhaled antibiotics in the presence 4/12 Fuch's criteria (Change in sputum, new/increased hemoptysis, increased cough, increased dyspnea, malaise, fatigue/lethargy, Temperature greater than 38C, weight loss, sinus pain, change in sinus discharge, change in exam of chest, decrease in FEV1 of more than 10%, radiographic change). This excludes prophylactic antibiotics. A new PEx is a one that occurs at 28 days after the previous PEx. The rate is calculate over a 28 week period from visit 1 to week 28 visit | 28 weeks (Baseline Day 0 to Week 28) |
| Pulmonary Exacerbation (PEx) | Time to first PEx using the secondary PEx definition with lenabasum 20 mg BID compared to placebo. The secondary definition of a PEx is based on the physician's diagnosis of pulmonary exacerbation and commencement of new oral, intravenous, or inhaled antibiotics. A new PEx is defined one that starts 28 or more days after the previous confirmed PEx. | 28 weeks (Baseline Day 0 to Week 28) |
| CFQ-R Respiratory Symptom Domain | Cystic Fibrosis Questionnaire - Revised measures change from baseline in CFQ-R respiratory symptom domain with lenabasum compared to placebo. Subjects >/= 14 years of age. 5 distinct 4-point Likert scales (e.g., always/often/ sometime/never) Scores for each HRQoL domain; after recoding, each item is summed to generate a domain score and standardized. Scores range from 0 to 100, with higher scores indicating better health. | 28 weeks (Change from Baseline Day 0 to Week 28) |
| FEV1 % Predicted | Change from baseline to week 28 in Forced Expiratory Volume in 1 second (FEV1) expressed as a percentage of a normal range. A lower percentage FEV1 is indicative of decrease in lung functionality. The changes observed from baseline to week 28 for lenabasum will be compared with those observed for placebo treated participants. | 28 weeks (Change from Baseline Day 0 to Week 28) |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Miller Children's Hospital | Long Beach | California | 90806 | United States |
| National Jewish Health | Denver | Colorado | 80206 | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| Central Florida Pulmonary Group, PA | Orlando | Florida | 32803 | United States |
| USF Center for Advance Lung Disease | Tampa | Florida | 33606 | United States |
| Emory Children's Center | Atlanta | Georgia | 30322 | United States |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States |
| The Cystic Fibrosis Institute | Glenview | Illinois | 60025 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21205 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| Dartmouth-Hitchcock Medical Center (main location) | Lebanon | New Hampshire | 03756 | United States |
| Dartmouth-Hitchcock Manchester (satellite site) | Manchester | New Hampshire | 03104 | United States |
| Atlantic Health Children's Hospital | Morristown | New Jersey | 07960 | United States |
| Rutgers Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08901 | United States |
| New York Medical College | Hawthorne | New York | 10532 | United States |
| North Shore LIJ Health System | New Hyde Park | New York | 11040 | United States |
| Mount Sinai Beth Israel | New York | New York | 10003 | United States |
| Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Milton S. Hershey Medical Center / Penn State College of Medicine | Hershey | Pennsylvania | 17033 | United States |
| Drexel University College of Medicine | Philadelphia | Pennsylvania | 19102 | United States |
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15224 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Sanford Children's Specialty Clinic | Sioux Falls | South Dakota | 57105 | United States |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Cook Children's Medical Center | Fort Worth | Texas | 76104 | United States |
| Texas Children's Hospital | Houston | Texas | 77030 | United States |
| The University of Texas Health Science Center at Tyler | Tyler | Texas | 75708 | United States |
| University of Utah | Salt Lake City | Utah | 84132 | United States |
| University Hospital and UW Health Clinics | Madison | Wisconsin | 53792 | United States |
| Cystic Fibrosis Centre Innsbruck Medical University of Innsbruck, Dept. for Child and Adolescent Health, University Clinic for Paediatrics, Cardiology, Pneumology, Allergology, Cystic Fibrosis | Innsbruck | Austria |
| Medical University of Vienna | Vienna | Austria |
| Universitair Ziekenhuis Brussel | Brussels | Belgium |
| Medical Center Prolet EOOD | Rousse | Bulgaria |
| UMHAT Alexandrovska | Sofia | Bulgaria |
| MHAT Sveta Marina EAD | Varna | Bulgaria |
| Centre hospitalier de l'Université de Montréal (CHUM) | Montreal | Canada |
| St. Michael's Hospital | Toronto | Canada |
| The Hospital for Sick Children | Toronto | Canada |
| St. Paul's Hospital | Vancouver | Canada |
| Motol University Hospital | Prague | Czechia |
| Centre de Référence de la Mucoviscidose | Bron | France |
| Service de Pneumologie, Allergologie, Mucoviscidose; Hôpital Femme-Mère-Enfant | Bron | France |
| Service de Pediatrie Medico-Chirurgicale et Genetique | Dijon | France |
| CHRU de Montpellier | Montpellier | France |
| CRCM Enfant de Nancy | Nancy | France |
| CHU de Nice | Nice | France |
| Centre de Recherche en Explorations Fonctionnelles (CREF) | Paris | France |
| CRCM Hôpital Necker | Paris | France |
| Foundation ILDYS | Roscoff | France |
| Nouvel Hopital Civil Strasbourg | Strasbourg | France |
| Charité Universitätsmedzin | Berlin | Germany |
| Catholic Hospital Bochum - St. Josef-Hospital | Bochum | Germany |
| University Hospital Essen | Essen | Germany |
| University Medicine Essen Ruhrlandklinik | Essen | Germany |
| Goethe University Children´s Hospital | Frankfurt | Germany |
| Hannover Medical School | Hanover | Germany |
| University Hospital Jena | Jena | Germany |
| Klinikum der Ludwig Maximilian Universität München | München | Germany |
| General Hospital of Thessaloniki Ippokratio | Thessaloniki | Greece |
| National Koranyi Institute of Pulmonology, Department of Cystic Fibrosis | Budapest | Hungary |
| University of Debrecen - Kenezy Gyula University Hospital | Debrecen | Hungary |
| Bács-Kiskun County Hospital, Teaching Hospital of the University of Szeged | Kecskemét | Hungary |
| Moritz Kaposi General Hospital, Mosdós, Department of Pediatric Pulmonary Rehabilitation | Mosdós | Hungary |
| Pediatric Pulmonology, Törökbálint, Hungary | Törökbálint | Hungary |
| Centro Regionale Toscano di Riferimento per la Fibrosi Cistica | Florence | Italy |
| U.O.S.D. - Centro fibrosi cistica | Genova | Italy |
| Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Milan | Italy |
| Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico | Milan | Italy |
| Azienda Ospedaliera Universitaria Verona | Verona | Italy |
| Radbound UMC | Nijmegen | Netherlands |
| Instytut Matki I Dziecka, Centrum Leczenia Mukowiscydozy - Oddzial Chorob Pluc | Dziekanów Leśny | 05-092 | Poland |
| Oddzial Pediatrii z Pododdzialem Leczenia Mukowiscydozy | Gdansk | Poland |
| Instytut Gruzlicy I Chorob Pluc Oddzial Terenowy im Jana I Ireny Rudnikow | Rabka-Zdrój | 34-700 | Poland |
| Institute for Mother and Child, Department of CF for Children's and Youth | Rzeszów | Poland |
| Hospital de Santa Maria | Lisbon | Portugal |
| Medial Center for Ambulatory Diagnosis and Treatment | Brasov | Romania |
| Scientfic Research Institute of Pulmonology | Moscow | Russia |
| Diagnostic Children Hospital, Department of Pediatrics and Adolescent Medicine, Department of Pediatric Pulmonary, Allergology and Endocrinology | Mytishchi | Russia |
| Children's City Hospital of Saint Olga | Saint Petersburg | Russia |
| First St. Petersburg State Pavlov Medical University | Saint Petersburg | Russia |
| Clinical for Pulmonary Diseases, Clinical Center of Serbia | Belgrade | Serbia |
| Institute for Pulmonary Disease of Vojvodina | Kamenitz | Serbia |
| Institute for Child and Youth Health Care of Vojvodina | Novi Sad | Serbia |
| Children's faculty hospital with polyclinic Banska Bystrica | Banská Bystrica | Slovakia |
| Children's Faculty Hospital Kosice | Košice | Slovakia |
| Unidad de Fibrosis Quistica Adultos | Barcelona | Spain |
| Unidad de Fibrosis Quistica Pediatria | Barcelona | Spain |
| Unidad de Fibrosis Quistica y Transplante Pulmonar | Valencia | Spain |
| Skane University Hospital | Lund | Sweden |
| Karolinska University Hospital | Stockholm | Sweden |
| Liverpool Heart and Chest Hospital | Liverpool | Merseyside | United Kingdom |
| Belfast City Hospital | Belfast | Northern Ireland | United Kingdom |
| Birmingham Women's and Children's NHS Foundation Trust | Birmingham | United Kingdom |
| University Hospitals Birmingham NHS Foundation Trust | Birmingham | United Kingdom |
| Royal Papworth Hospital NHS Foundation Trust | Cambridge | United Kingdom |
| Cardiff and Vale University Health Board | Llandough | United Kingdom |
| Barts Health NHS Trust | London | United Kingdom |
| Royal Brompton & Harefield NHS Foundation Trust | London | United Kingdom |
| Wolfson Cystic Fibrosis Centre City Hospital Campus | Nottingham | United Kingdom |
| University Hospital Southampton NHS Foundation Trust | Southampton | United Kingdom |
| FG002 | Placebo | subjects received placebo BID |
| COMPLETED |
|
| NOT COMPLETED |
|
|
modified intent to treat population
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Lenabasum 20 mg BID | Lenabasum 20 mg: Subjects will receive lenabasum 20 mg twice daily. |
| BG001 | Lenabasum 5 mg BID | Lenabasum 5 mg: Subjects will receive lenabasum 5 mg twice daily. |
| BG002 | Placebo | subjects received placebo BID |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| FEV1 (L) | Mean | Standard Deviation | liters |
| |||||||||||||||
| Number of Acute Pulmonary Exacerbations in Past Year | Count of Participants | Participants |
| ||||||||||||||||
| CFTR Genotype | Count of Participants | Participants |
| ||||||||||||||||
| Weight | Mean | Standard Deviation | kg |
|
| 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 | Pulmonary Exacerbation (PEx) Rate Over 28 Weeks | Rate of PEx using the primary PEx definition with lenabasum 20 mg BID compared to placebo, during the treatment period. An primary PEx is defined on the physician's decision to treat with oral, intraveneous or inhaled antibiotics in the presence 4/12 Fuch's criteria (Change in sputum, new/increased hemoptysis, increased cough, increased dyspnea, malaise, fatigue/lethargy, Temperature greater than 38C, weight loss, sinus pain, change in sinus discharge, change in exam of chest, decrease in FEV1 of more than 10%, radiographic change). This excludes prophylactic antibiotics. A new PEx is a one that occurs at 28 days after the previous PEx. | modified intent to treat population | Posted | Number | events per participant/28 weeks | 28 weeks (Baseline Day 0 to Week 28) |
|
|
| ||||||||||||||||||||||||||||||||
| Secondary | Pulmonary Exacerbation (PEx) Rate | Event rate of PEx using the secondary PEx definition with lenabasum 20 mg BID compared to placebo. The secondary definition of a PEx is based on the physician's diagnosis of pulmonary exacerbation and commencement of new oral, intravenous, or inhaled antibiotics. A new PEx is defined one that starts 28 or more days after the previous confirmed PEx. The PEx rate is calculated as the number of PEx/28 weeks | modified intent to treat population | Posted | Number | events per participant/28 weeks | 28 weeks (Baseline Day 0 to Week 28) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Time to First New Pulmonary Exacerbation (PEx) | Time to first new PEx using the primary PEx definition with lenabasum 20 mg BID compared to placebo. An primary PEx is defined on the physician's decision to treat with oral, intraveneous or inhaled antibiotics in the presence 4/12 Fuch's criteria (Change in sputum, new/increased hemoptysis, increased cough, increased dyspnea, malaise, fatigue/lethargy, Temperature greater than 38C, weight loss, sinus pain, change in sinus discharge, change in exam of chest, decrease in FEV1 of more than 10%, radiographic change). This excludes prophylactic antibiotics. A new PEx is a one that occurs at 28 days after the previous PEx. The rate is calculate over a 28 week period from visit 1 to week 28 visit | modified intent to treat population | Posted | Median | Inter-Quartile Range | days | 28 weeks (Baseline Day 0 to Week 28) |
| |||||||||||||||||||||||||||||||||
| Secondary | Pulmonary Exacerbation (PEx) | Time to first PEx using the secondary PEx definition with lenabasum 20 mg BID compared to placebo. The secondary definition of a PEx is based on the physician's diagnosis of pulmonary exacerbation and commencement of new oral, intravenous, or inhaled antibiotics. A new PEx is defined one that starts 28 or more days after the previous confirmed PEx. | modified intent to treat population | Posted | Median | Inter-Quartile Range | days | 28 weeks (Baseline Day 0 to Week 28) |
|
| ||||||||||||||||||||||||||||||||
| Secondary | CFQ-R Respiratory Symptom Domain | Cystic Fibrosis Questionnaire - Revised measures change from baseline in CFQ-R respiratory symptom domain with lenabasum compared to placebo. Subjects >/= 14 years of age. 5 distinct 4-point Likert scales (e.g., always/often/ sometime/never) Scores for each HRQoL domain; after recoding, each item is summed to generate a domain score and standardized. Scores range from 0 to 100, with higher scores indicating better health. | modified intent to treat population | Posted | Least Squares Mean | Standard Error | scores on a scale | 28 weeks (Change from Baseline Day 0 to Week 28) |
|
| ||||||||||||||||||||||||||||||||
| Secondary | FEV1 % Predicted | Change from baseline to week 28 in Forced Expiratory Volume in 1 second (FEV1) expressed as a percentage of a normal range. A lower percentage FEV1 is indicative of decrease in lung functionality. The changes observed from baseline to week 28 for lenabasum will be compared with those observed for placebo treated participants. | modified intent to treat population | Posted | Least Squares Mean | Standard Error | percentage of Predicted FEV1 | 28 weeks (Change from Baseline Day 0 to Week 28) |
|
|
28 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lenabasum 20 mg BID | Lenabasum 20 mg: Subjects will receive lenabasum 20 mg twice daily. | 0 | 165 | 50 | 165 | 151 | 165 |
| EG001 | Lenabasum 5 mg BID | Lenabasum 5 mg: Subjects will receive lenabasum 5 mg twice daily. | 0 | 89 | 25 | 89 | 80 | 89 |
| EG002 | Placebo | subjects received placebo BID | 0 | 171 | 50 | 171 | 151 | 171 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Tachcardia | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Non-compaction cardiomyopathy | Congenital, familial and genetic disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Distal intestinal obstruction syndrome | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Biliary colic | Hepatobiliary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Fungal disease carrier | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Forced expiratory volume decreased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Human rhinovirus test positive | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pulmonary function test positive | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cystitis haemorrhagic | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Testicular torsion | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Infective pulmonary exacerbation of cystic fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal disorders | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| General disorders and administration site conditions | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Immune system disorders | Immune system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Infections and infestations | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Investigations | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Musculoskeletal and connective tissues | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Nervous system | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Psychiatric | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Renal and urinary | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Respiratory, thoracic and mediastinal | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Skin and subcutaneous | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Clinical Operations | Corbus Pharmaceuticals, Inc. | 6179630100 | info@corbuspharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 21, 2020 | Apr 5, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C471849 | lenabasum |
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 |
|
| two |
|
| three |
|
| four |
|
| five |
|
| six or more |
|
| F508del/other |
|
| Other/other or unknown |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Participants |
|
|
|