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5-mg Desloratadine

Phase 3

Allergic Rhinitis | Small molecule | Other |Organon & Co.|Last Updated: May 20, 2024

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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment716
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00405964Study for the Treatment of Persistent Allergic Rhinitis With Desloratadine (Study P04684)PHASE3 COMPLETED 716Sep 1, 2006Apr 1, 2008May 20, 2024 -
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Study Endpoints
Primary Endpoints
Change From Baseline in Participant's AM/PM PRIOR Total 5 Symptom Score (T5SS) Over Days 1 to 29 of Treatment
Baseline and Days 1-29

AM/PM PRIOR (the participant's status over previous 12 hours) T5SS from the participant's daily diary averaged over treatment Days 1 to 29. AM/PM is the average of separate morning (AM) and evening (PM) evaluations. Scores were defined for T5SS as 0: no symptoms to 15: all severe symptoms. A two-way analysis of variance (ANOVA) model with treatment and site effects was used to examine the treatment difference.

Secondary Endpoints
Change From Baseline in the Total Rhinoconjunctivitis Quality of Life Questionnaire-Standarized Version (RQLQ-S) After 29 Days of Treatment
Baseline and Day 29
Change From Baseline in Participant's AM/PM PRIOR T5SS Over Days 1 to 85 of Treatment
Baseline and Days 1-85
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
5-mg Desloratadine tabletEXPERIMENTAL -
Placebo tabletPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
5-mg DesloratadineDRUG5-mg Desloratadine tablet, once daily for 12 weeks
Placebo tabletDRUGPlacebo tablet, once daily for 12 weeks
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Eligibility Criteria
Age Range12 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * For this study, the diagnosis of persistent allergic rhinitis (PER) is not based solely on the current episode of allergic rhinitis (AR). Subjects must have at least a 2 year history of AR consistent with PER (defined as symptoms of allergic rhinitis present more than four day...

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Competitive Landscape -Allergic Rhinitis 4 trials