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FEX60/PE10

Phase 3

Rhinitis Allergic | Small molecule | Respiratory |Sanofi|Last Updated: Nov 30, 2015

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment105

FDA Designations

No designations recorded

Clinical trial landscape

FEX60/PE10 · 1 trial · 1 indication

Phase 3 1
NCT02401191A Study Assessing the Safety and Effectiveness of FEX60/PE10 Fixed Combination Tablet in Patients With Allergic RhinitisRhinitis Allergic
COMPLETED105 Analytics
PHASE3COMPLETED
A Study Assessing the Safety and Effectiveness of FEX60/PE10 Fixed Combination Tablet in Patients With Allergic Rhinitis
Rhinitis Allergic
NCT02401191105
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Study Endpoints

Primary Endpoints

Number of adverse events (Solicited AE reporting)
From intake of FEX60/PE10 up to approximately 2 weeks
Changes from baseline in the nasal congestion score based on the patient's symptom diary
After 2 weeks treatment

Secondary Endpoints

Change from baseline in the total score of 3 nasal symptoms (sneezing, rhinorrhea, and nasal congestion)
After 2 weeks treatment
Change in the total score of 3 nasal symptoms on a daily basis
After 2 weeks treatment
Change in the total score of 3 nasal symptoms during daytime
After 2 weeks treatment
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
FEX60/PE10EXPERIMENTALInternal use of FEX60/PE10 combination tablet will be administered twice daily (1 tablet per intake) for 2 weeks

Interventions

NameTypeDescription
FEX60/PE10DRUGPharmaceutical form:tablet Route of administration: oral
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Eligibility Criteria

Age Range15 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion criteria: * Outpatients with a history of seasonal or perennial allergic rhinitis for at least 1 year confirmed by positive skin prick test to out or indoor allergens (wheal ≥3mm compared to control \[diluent\]) or positive specific IgE Antibody test (ie, radioallergosorbent test \[RAST\]...

Countries:Japan
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Frequently asked questions about FEX60/PE10

What is FEX60/PE10 used for?

FEX60/PE10 is an investigational fixed combination tablet being studied for the treatment of allergic rhinitis. It is a small molecule developed by Sanofi. The drug is currently in Phase 3 clinical development, though the specific trial evaluating it has been completed.

Who makes FEX60/PE10?

FEX60/PE10 is developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker SNY. The drug is being investigated as a treatment for allergic rhinitis and is currently in Phase 3 clinical development.

What phase is FEX60/PE10 in?

FEX60/PE10 is in Phase 3 clinical development. The drug is being studied for allergic rhinitis, and the Phase 3 trial has been completed. FEX60/PE10 remains investigational and has not been approved by regulatory authorities.

What clinical trials is FEX60/PE10 in?

FEX60/PE10 has been evaluated in a Phase 3 clinical trial registered as NCT02401191. This study assessed the safety and effectiveness of the FEX60/PE10 fixed combination tablet in patients with allergic rhinitis. The trial enrolled 105 participants in Japan and has been completed.

Is FEX60/PE10 the same as FEX60/PE10?

FEX60/PE10 is the name of the fixed combination tablet being developed by Sanofi for allergic rhinitis. The drug is also referred to by its clinical trial identifier, NCT02401191, in research contexts. No other alternative names have been established for this investigational product.