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Bilastine

Phase 2

Seasonal Allergic Rhinitis | Small molecule | Ophthalmology |Merck & Company, Inc.|Last Updated: Feb 15, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment805

FDA Designations

No designations recorded

Clinical trial landscape

Bilastine · 1 trial · 4 indications

Phase 2 1
NCT00574379Efficacy, Safety and PK of Once or Twice Daily Bilastine (10 or 20 mg) Compared With Placebo in the Symptomatic Treatment of SARSeasonal Allergic Rhinitis
COMPLETED805 Analytics
PHASE2COMPLETED
Efficacy, Safety and PK of Once or Twice Daily Bilastine (10 or 20 mg) Compared With Placebo in the Symptomatic Treatment of SAR
Seasonal Allergic RhinitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in nasal symptom scores
14 days

Secondary Endpoints

Change in ocular symptom scores and quality of life scores; standard safety assessments
14 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALBilastine 20mg once per day
2EXPERIMENTALBilastine 20mg twice per day
3EXPERIMENTALBilastine 10mg once per day
4EXPERIMENTALBilastine 10mg twice per day
5PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
BilastineDRUGBilastine 10 or 20mg, once or twice daily for 14 days. Tablets
PlaceboDRUGPlacebo tablets twice daily for 14 days
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Eligibility Criteria

Age Range12 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: * clinical history of Seasonal Allergic Rhinoconjunctivitis with seasonal onset and offset of nasal allergy symptoms * documentation of a positive skin test within one year of screening to Mountain Cedar allergen Exclusion Criteria: * significant medical condition * significan...

Countries:United States
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Frequently asked questions about Bilastine

What is Bilastine used for?

Bilastine is an investigational small molecule being studied for the symptomatic treatment of seasonal allergic rhinitis, also known as hay fever. It is being evaluated in the therapeutic area of ophthalmology. The drug is currently in Phase 2 clinical development and is not approved by the FDA.

Who makes Bilastine?

Bilastine is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's efficacy and safety for the treatment of seasonal allergic rhinitis.

What phase is Bilastine in?

Bilastine is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 2 trial has been completed, and the drug is not currently in any active clinical trials.

What clinical trials is Bilastine in?

Bilastine has one completed clinical trial registered under NCT00574379. This Phase 2 study evaluated the efficacy, safety, and pharmacokinetics of once or twice daily Bilastine (10 or 20 mg) compared with placebo in the symptomatic treatment of seasonal allergic rhinitis. The trial enrolled 805 participants in the United States.

Is Bilastine the same as any other drug?

Bilastine is a distinct investigational drug being developed by Merck & Company, Inc. No alternative names for Bilastine have been reported in the clinical trial data. It is being studied specifically for seasonal allergic rhinitis and associated conditions such as allergic conjunctivitis.