Recent Updates
Recently added Catalysts

JNJ 40929837

Phase 2

Asthma | Small molecule | Respiratory |Johnson & Johnson|Last Updated: Dec 21, 2015

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment22
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01241422A Study to Evaluate the Effectiveness of JNJ 40929837 for the Treatment of Asthma Using a Bronchial Allergen Challenge ModelPHASE2 COMPLETED 22Nov 1, 2010Jun 1, 2011Dec 21, 20152 Germany, United Kingdom
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Change in forced expiratory volume in 1 second (FEV1) during the late response to allergen
3 to 10 hours after allergen exposure on Day 6 of each treatment period
Secondary Endpoints
Change in FEV1 during the early response to allergen
0-2 hours after allergen exposure on Day 6 of each treatment period
Area under the FEV1/time curve during the early response to allergen
Between 0 and 2 hours post allergen challenge on Day 6
Area under the FEV1/time curve during the late response to allergen
Between 3 and 10 hours post allergen challenge on Day 6
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Treatment A: JNJ 40929837EXPERIMENTAL -
Treatment B: PlaceboPLACEBO_COMPARATOR -
Treatment C: MontelukastOTHER -
Interventions
NameTypeDescription
JNJ 40929837DRUGOn Day 1: participants will receive 2 tablets of 50 mg JNJ 40929837 in the morning and 1 placebo capsule in the evening; from Days 2 to 6: they will receive 1 tablet of 50 mg JNJ 40929837 in the morning and 1 JNJ 40929837 50 mg tablet + 1 placebo capsule in the evening; and on Day 7: 1 tablet of 50 mg JNJ 40929837 in the morning.
PlaceboDRUGOn Day 1: participants will receive 2 placebo tablets in the morning and 1 placebo capsule in the evening; from Days 2 to 6: they will receive 1 placebo tablet in the morning and 1 placebo tablet + 1 placebo capsule in the evening; and on Day 7: 1 placebo tablet in the morning.
MontelukastDRUGOn Day 1: participants will receive 2 placebo tablets in the morning and 1 montelukast capsule in the evening; from Days 2 to 6: they will receive 1 placebo tablet in the morning and 1 montelukast capsule + 1 placebo tablet in the evening; and on Day 7: 1 placebo tablet in the morning.
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: - Generally healthy - Have mild atopic asthma requiring no other treatment besides occasional short-acting beta-2-agonists - Have allergen-induced early asthmatic response of at least a 20 percent reduction in forced expiratory volume in 1 second (FEV1) and late asthmatic respons...

Countries:GermanyUnited Kingdom
Unlock Eligibility Criteria