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JNJ-63623872

Phase 2

Influenza A Virus | Small molecule | Infectious Disease |Johnson & Johnson|Last Updated: Mar 27, 2020

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-BlindCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment102
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02532283A Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of JNJ-63623872 in Combination With Oseltamivir in Adult, and Elderly Hospitalized Participants With Influenza A InfectionPHASE2 COMPLETED 102 — — Dec 11, 2015Mar 15, 2017Mar 27, 202068 United States, Australia +13
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Study Endpoints
Primary Endpoints
Maximum Observed Plasma Concentration (Cmax) of Pimodivir
Pre-dose, 1, 2, 4, 6, 8, 10 and 12 hours post-dose on Day 3

Cmax is the maximum observed plasma concentration. As per planned analysis, results are presented by age groups (65 to less than or equal to \[\<=\] 85 years and 18 to \<=64 years).

Minimum Observed Plasma Concentration (Cmin) of Pimodivir
Pre-dose, 1, 2, 4, 6, 8, 10 and 12 hours post-dose on Day 3

Cmin is the minimum observed plasma concentration. As per planned analysis, results are presented by age groups (65 to \<= 85 years and 18 to \<=64 years).

Area Under the Plasma Concentration-time Curve From Time of Administration to 12 Hours After Dosing (AUC [0-12]) of Pimodivir
Pre-dose, 1, 2, 4, 6, 8, 10 and 12 hours post-dose on Day 3

AUC (0-12) is the area under the plasma concentration-time curve from time zero to 12 hours after dosing of pimodivir. As per planned analysis, results are presented by age groups (65 to \<= 85 years and 18 to \<=64 years).

Secondary Endpoints
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious AEs (TESAEs)
Up to 28 Days
Time to Influenza A Viral Negativity
Up to 14 Days
Influenza Viral Load Over Time
Baseline, Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
JNJ-63623872 plus OseltamivirEXPERIMENTALParticipants will be administered JNJ-63623872 600 milligram (mg) tablets and oseltamivir 75 mg capsules orally twice daily for 7 days.
Placebo plus OseltamivirEXPERIMENTALParticipants will be administered placebo tablets and oseltamivir 75 mg capsules orally twice daily for 7 days.
Interventions
NameTypeDescription
JNJ-63623872DRUGParticipants will be administered JNJ-63623872 600 milligram (mg) tablets orally twice daily for 7 days.
PlaceboDRUGParticipants will be administered placebo tablets orally twice daily for 7 days.
OseltamivirDRUGParticipants will be administered oseltamivir 75 mg capsules orally twice daily for 7 days.
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Eligibility Criteria
Age Range18 Years — 85 Years
SexALL
Healthy VolunteersNo
Study Sites68

Inclusion Criteria: * Participant requires hospitalization to treat influenza infection and/or to treat complications of influenza infection * Participant tested positive for influenza A infection within 1 day of signing of the informed consent form (ICF)/assent form using a polymerase chain reacti...

Countries:United StatesAustraliaBelgiumBrazilCanadaFranceGermanyHong KongMalaysiaNetherlandsNew ZealandSingaporeSpainSwedenTurkey (Türkiye)
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