CompletedNCT03451045Updated Jan 18, 2023Results posted

Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis

A Phase 2 interventional study of Lenabasum 20 mg and Lenabasum 5 mg in Cystic Fibrosis, sponsored by Corbus Pharmaceuticals Inc.. Completed at 105 sites in 21 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2023-01-18.

Sponsored by Corbus Pharmaceuticals Inc. · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 447
Allocation: Randomized
Ages: 12 Years and older
Sex: All

Study summary

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.

Conditions studied

Cystic Fibrosis

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Keywords

Pulmonary exacerbation, lenabasum, JBT-101

Who can participate

Ages eligible: 12 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

≥ 12 years of age at the time Informed Consent/ Assent is signed.
Weight ≥ 40 kg.
FEV1 ≥ 40% predicted and \< 100% predicted in the last 12 months.
Physician-initiated treatment with an IV antibiotic 2 or 3 times in the last 12 months for a new PEx or physician-initiated treatment with an IV antibiotic 1 time in the last 12 months plus physician-initiated treatment with oral antibiotic(s) 1 or more times in the past 12 months for a new PEX.

Exclusion criteria

Exclusion Criteria:

Severe or unstable CF at screening or Visit 1.
Any of the following values for laboratory tests at screening:
1. A positive pregnancy test.
2. Hemoglobin \< 10 g/dL in males and \< 9 g/dL in females.
3. Neutrophils \< 1.0 x 10\^9 /L.
4. Platelets \< 75 x 10\^9/L.
5. Creatinine clearance \< 50 mL/min according to Modification of Diet in Renal Disease (MDRD) Study equation.
6. Serum transaminases > 2.5 x upper limit of normal.
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.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 447 participants (actual)

Study arms

Experimental
Lenabasum 20 mg BID
Drug: Lenabasum 20 mg
Experimental
Lenabasum 5 mg BID
Drug: Lenabasum 5 mg
Placebo comparator
Placebo BID
Other: Placebo

Interventions

DrugLenabasum 20 mg
Subjects will receive lenabasum 20 mg twice daily.
DrugLenabasum 5 mg
Subjects will receive lenabasum 5 mg twice daily.
OtherPlacebo
Subjects will receive placebo twice daily.

What researchers measure

Primary outcomes

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.
Time frame: 28 weeks (Baseline Day 0 to Week 28)

Secondary outcomes

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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 28 weeks (Change from Baseline Day 0 to Week 28)

Results

Posted Jan 18, 2023

Participant flow

Participant flow — Overall Study
Milestone	Lenabasum 20 mg BID	Lenabasum 5 mg BID	Placebo
Started	175	91	181
Completed	148	85	154
Not completed	27	6	27
Withdrew: Lack of efficacy	3	2	2
Withdrew: Physician decision	1	1	1
Withdrew: Withdrawal by subject	4	0	5
Withdrew: Pregnancy	0	0	2
Withdrew: Adverse event	7	1	3
Withdrew: Non-compliance with study	2	0	1
Withdrew: Any other reason	10	2	13

Outcome measures

PrimaryPulmonary 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.

Time frame:: 28 weeks (Baseline Day 0 to Week 28)
Reported as:: Number · events per participant/28 weeks

Pulmonary Exacerbation (PEx) Rate Over 28 Weeks
events per participant/28 weeks	Lenabasum 20 mg BID	Lenabasum 5 mg BID	Placebo BID
Pulmonary Exacerbation (PEx) Rate Over 28 Weeks	0.911	0.749	0.842

SecondaryPulmonary 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

Time frame:: 28 weeks (Baseline Day 0 to Week 28)
Reported as:: Number · events per participant/28 weeks

Pulmonary Exacerbation (PEx) Rate
events per participant/28 weeks	Lenabasum 20 mg BID	Lenabasum 5 mg BID	Placebo
Pulmonary Exacerbation (PEx) Rate	1.08	0.91	1.03

SecondaryTime 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

Time frame:: 28 weeks (Baseline Day 0 to Week 28)
Reported as:: Median · days

Time to First New Pulmonary Exacerbation (PEx)
days	Lenabasum 20 mg BID	Lenabasum 5 mg BID	Placebo
Time to First New Pulmonary Exacerbation (PEx)	162 (59 to 183)	148 (58 to 183)	143 (58 to 183)

SecondaryPulmonary 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.

Time frame:: 28 weeks (Baseline Day 0 to Week 28)
Reported as:: Median · days

Pulmonary Exacerbation (PEx)
days	Lenabasum 20 mg BID	Lenabasum 5 mg BID	Placebo
Pulmonary Exacerbation (PEx)	116 (38 to 183)	113 (54 to 183)	120 (49 to 183)

SecondaryCFQ-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.

Time frame:: 28 weeks (Change from Baseline Day 0 to Week 28)
Reported as:: Least squares mean · scores on a scale

CFQ-R Respiratory Symptom Domain
scores on a scale	Lenabasum 20 mg BID	Lenabasum 5 mg BID	Placebo
CFQ-R Respiratory Symptom Domain	1.16 ± 1.41	-2.92 ± 1.88	-0.96 ± 1.41

SecondaryFEV1 % 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.

Time frame:: 28 weeks (Change from Baseline Day 0 to Week 28)
Reported as:: Least squares mean · percentage of Predicted FEV1

FEV1 % Predicted
percentage of Predicted FEV1	Lenabasum 20 mg BID	Lenabasum 5 mg BID	Placebo
FEV1 % Predicted	0.014 ± 0.025	-0.005 ± 0.033	-0.012 ± 0.025

Adverse events

Collected over 28 weeks. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Lenabasum 20 mg BID	0/165 (0%)	50/165 (30.3%)	151/165 (91.5%)
Lenabasum 5 mg BID	0/89 (0%)	25/89 (28.1%)	80/89 (89.9%)
Placebo	0/171 (0%)	50/171 (29.2%)	151/171 (88.3%)

Most frequent serious events

Showing 10 of 33

Most frequent serious events
Event	Lenabasum 20 mg BID	Lenabasum 5 mg BID	Placebo
Infective pulmonary exacerbation of cystic fibrosisRespiratory, thoracic and mediastinal disorders	42/165	22/89	41/171
Distal intestinal obstruction syndromeGastrointestinal disorders	3/165	1/89	3/171
HaemoptysisRespiratory, thoracic and mediastinal disorders	3/165	1/89	1/171
InfluenzaInfections and infestations	0/165	0/89	2/171
Forced expiratory volume decreasedInvestigations	1/165	0/89	2/171
DehydrationMetabolism and nutrition disorders	0/165	1/89	0/171
HeadacheNervous system disorders	0/165	1/89	0/171
Renal colicRenal and urinary disorders	0/165	1/89	0/171
UreterolithiasisRenal and urinary disorders	0/165	1/89	0/171
TachcardiaCardiac disorders	1/165	0/89	0/171

Most frequent other events

Showing 10 of 11

Most frequent other events
Event	Lenabasum 20 mg BID	Lenabasum 5 mg BID	Placebo
Respiratory, thoracic and mediastinalRespiratory, thoracic and mediastinal disorders	120/165	65/89	122/171
Infections and infestationsInfections and infestations	75/165	36/89	72/171
Gastrointestinal disordersGastrointestinal disorders	45/165	23/89	43/171
Nervous systemNervous system disorders	41/165	18/89	28/171
General disorders and administration site conditionsGeneral disorders	39/165	22/89	33/171
InvestigationsInvestigations	35/165	22/89	30/171
Musculoskeletal and connective tissuesMusculoskeletal and connective tissue disorders	17/165	14/89	18/171
PsychiatricPsychiatric disorders	11/165	10/89	11/171
Skin and subcutaneousSkin and subcutaneous tissue disorders	12/165	5/89	17/171
Renal and urinaryRenal and urinary disorders	1/165	5/89	8/171

Baseline characteristics

modified intent to treat population

Age, Continuous
Age, Continuous(years)	Lenabasum 20 mg BID	Lenabasum 5 mg BID	Placebo	Total
Mean	26.2 ± 9.08	28.9 ± 11.24	26.6 ± 10.81	26.9 ± 10.5

Sex: Female, Male
Sex: Female, Male(Participants)	Lenabasum 20 mg BID	Lenabasum 5 mg BID	Placebo	Total
Female	91	44	93	228
Male	74	45	78	197

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Lenabasum 20 mg BID	Lenabasum 5 mg BID	Placebo	Total
Hispanic or Latino	5	3	5	13
Not Hispanic or Latino	155	84	164	403
Unknown or Not Reported	5	2	2	9

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Lenabasum 20 mg BID	Lenabasum 5 mg BID	Placebo	Total
American Indian or Alaska Native	0	0	0	0
Asian	1	0	1	2
Native Hawaiian or Other Pacific Islander	0	0	0	0
Black or African American	0	2	3	5
White	161	86	163	410
More than one race	1	0	1	2
Unknown or Not Reported	2	1	3	6

Body Mass Index
Body Mass Index(kg/m^2)	Lenabasum 20 mg BID	Lenabasum 5 mg BID	Placebo	Total
Mean	21.07 ± 3.179	22.26 ± 4.164	21.52 ± 3.931	21.50 ± 3.728

FEV1 (L)
FEV1 (L)(liters)	Lenabasum 20 mg BID	Lenabasum 5 mg BID	Placebo	Total
Mean	2.10 ± 0.73	2.20 ± 0.77	2.17 ± 0.75	2.15 ± 0.76

Number of Acute Pulmonary Exacerbations in Past Year
Number of Acute Pulmonary Exacerbations in Past Year(Participants)	Lenabasum 20 mg BID	Lenabasum 5 mg BID	Placebo	Total
one	1	0	1	2
two	75	43	76	194
three	63	30	69	162
four	20	11	13	44
five	6	4	10	20
six or more	0	1	2	3

CFTR Genotype
CFTR Genotype(Participants)	Lenabasum 20 mg BID	Lenabasum 5 mg BID	Placebo	Total
F508del/F508del	83	34	74	191
F508del/other	56	38	70	164
Other/other or unknown	26	17	27	70

1 further baseline measures are reported on the registry.

Study locations

105 sites

Phoenix Children's Hospital
Phoenix, Arizona 85016, United States
University of Arkansas for Medical Sciences
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
Ruse, Bulgaria
UMHAT Alexandrovska
Sofia, Bulgaria
MHAT Sveta Marina EAD
Varna, Bulgaria
Centre hospitalier de l'Université de Montréal (CHUM)
Montréal, Canada
St. Michael's Hospital
Toronto, Canada
The Hospital for Sick Children
Toronto, Canada
St. Paul's Hospital
Vancouver, Canada
Motol University Hospital
Praha, 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
Thessaloníki, 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
Torokbalint, Hungary
Centro Regionale Toscano di Riferimento per la Fibrosi Cistica
Firenze, Italy
U.O.S.D. - Centro fibrosi cistica
Genova, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milano, Italy
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Milano, Italy
Azienda Ospedaliera Universitaria Verona
Verona, Italy
Radbound UMC
Nijmegen, Netherlands
Instytut Matki I Dziecka, Centrum Leczenia Mukowiscydozy - Oddzial Chorob Pluc
Dziekanow Lesny, 05-092, Poland
Oddzial Pediatrii z Pododdzialem Leczenia Mukowiscydozy
Gdańsk, 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
Lisboa, Portugal
Medial Center for Ambulatory Diagnosis and Treatment
Braşov, Romania
Scientfic Research Institute of Pulmonology
Moscow, Russian Federation
Diagnostic Children Hospital, Department of Pediatrics and Adolescent Medicine, Department of Pediatric Pulmonary, Allergology and Endocrinology
Mytishchi, Russian Federation
Children's City Hospital of Saint Olga
Saint Petersburg, Russian Federation
First St. Petersburg State Pavlov Medical University
St. Petersburg, Russian Federation
Clinical for Pulmonary Diseases, Clinical Center of Serbia
Belgrade, Serbia
Institute for Child and Youth Health Care of Vojvodina
Novi Sad, Serbia
Institute for Pulmonary Disease of Vojvodina
Sremska Kamenica, 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

Showing the first 100 of 105 sites across 21 countries.

References and documents

Study documents

Study protocol · Nov 5, 2019
Statistical analysis plan · Sep 21, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

Registry details

Key details

Study ID: NCT03451045
Lead sponsor: Corbus Pharmaceuticals Inc.
Collaborators: Cystic Fibrosis Foundation
Responsible party: Sponsor
First posted: Mar 1, 2018
Start date: Dec 22, 2017
Primary completion: Jun 17, 2020
Completion: Jun 17, 2020
Results posted: Jan 18, 2023
Last update: Jan 18, 2023

Study contacts

James Chmiel, MD

principal investigator · Indiana University School of Medicine/Riley Physicians Pulmonary

J. Stuart Elborn, MD

principal investigator · National Heart and Lung Institute, Imperial College

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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