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JNJ 49095397

Phase 2

Chronic Obstructive Pulmonary Disease | Small molecule | Other |Johnson & Johnson|Last Updated: Aug 21, 2019

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment211
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01867762An Effectiveness and Safety Study of Inhaled JNJ 49095397 (RV568) in Patients With Moderate to Severe Chronic Obstructive Pulmonary DiseasePHASE2 COMPLETED 211 — — Sep 9, 2013Sep 1, 2014Aug 21, 201947 United States, Belgium +9
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Study Endpoints
Primary Endpoints
Change From Baseline in Prebronchodilator (preBD, before taking an inhaled bronchodilator) Percent-predicted Forced Expiratory Volume in one Second (FEV1) at Week 12
Baseline (Week 0) to Week 12

FEV1 is the amount of air that can be exhaled in one second. FEV1 will be measured by spirometry. A positive change from baseline in FEV1 indicates improvement in lung function.

Secondary Endpoints
Change From Baseline in Postbronchodilator (postBD, after taking an inhaled bronchodilator) FEV1 at Week 12
Baseline (Week 0) to Week 12
Change From Baseline in Weekly Average Number of Occasions in a day that Rescue Medication is Used at Week 12
Baseline (Week 0) to Week 12
Change From Baseline in EXAcerbations of Chronic Pulmonary Disease Tool-Respiratory Symptoms (E-RS) at Week 12
Baseline (Week 0) to Week 12
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
JNJ 49095397EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
JNJ 49095397DRUGJNJ 49095397 400 microgram will be inhaled by participants once daily by using a dry powder inhaler for 12 weeks.
PlaceboDRUGPlacebo will be inhaled by participants once daily by using a dry powder inhaler for 12 weeks.
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Eligibility Criteria
Age Range40 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites47

Inclusion Criteria: * Men and women of non-child-bearing potential, Global Initiative for Chronic Obstructive Lung Disease (GOLD 2 or 3), forced expiratory volume in one second (FEV1) greater than or equal to 40 less than 80 percent predicted, FEV1/ forced vital capacity (FVC) ratio less than 0.7 *...

Countries:United StatesBelgiumCanadaCzechiaGermanyHungaryNetherlandsPolandRomaniaRussiaUnited Kingdom
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