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FEX60/PE10

Phase 3

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

FEX60/PE10 development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Mar 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

FEX60/PE10 clinical trials

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 AllergicUnlock trial analytics

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.