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R940343

Phase 2

Asthma | Small molecule | Respiratory |Rigel Pharmaceuticals, Inc.|Trials Updated: Sep 29, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment301

FDA Designations

No designations recorded

R940343 clinical trials

R940343 · 1 trial · 1 indication

Phase 2 1
NCT01591044A Safety and Efficacy Study of Inhaled R940343 in Patients With Mild to Moderate AsthmaAsthma
COMPLETED301 Analytics
PHASE2COMPLETED
A Safety and Efficacy Study of Inhaled R940343 in Patients With Mild to Moderate Asthma
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in FEV1
Baseline and Week 8

Change from baseline in pre-BD FEV1 (% predicted) at Week 8.

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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
R940343 2mg, 2 puffs bidACTIVE_COMPARATORR343 2mg, 2 puffs bid
PlaceboPLACEBO_COMPARATOR -
R940343 1mg, 1 puff bidACTIVE_COMPARATORR343 1mg, 1 puff bid

Interventions

NameTypeDescription
PlaceboDRUG1 puff bid or 2 puffs bid
R940343 1mgDRUGR343 1mg, 1 puff bid
R940343 2mgDRUGR343 2mg, 2 puffs bid
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites59

Inclusion Criteria: * Clinical history of asthma * Ability to perform spirometry Exclusion Criteria: * Chronic obstructive pulmonary disease or bronchiectasis * Upper or lower respiratory infection

Countries:United StatesCanada
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Frequently asked questions about R940343

What is R940343?

R940343 is an inhaled small molecule developed by Rigel Pharmaceuticals, Inc. (ticker RIGL) as a potential treatment for asthma. It has been studied in a Phase 2 clinical trial in patients with mild to moderate asthma. R940343 is an investigational drug and is not approved for any indication.

What is R940343 used for?

R940343 was studied for the treatment of mild to moderate asthma. The Phase 2 trial enrolled 301 patients aged 18 years and older in the United States and Canada. R940343 remains investigational and is not approved for the treatment of asthma or any other condition.

Who makes R940343?

R940343 is developed by Rigel Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker symbol RIGL. Rigel is the sponsor of the clinical program evaluating inhaled R940343 in patients with mild to moderate asthma.

What phase is R940343 in?

R940343 has completed a Phase 2 clinical trial in patients with mild to moderate asthma. The trial was randomized, double blind, and placebo controlled, and enrolled 301 patients. R940343 is an investigational drug and has not been approved by the FDA.

What clinical trials is R940343 in?

R940343 has been evaluated in one completed Phase 2 trial, NCT01591044, titled A Safety and Efficacy Study of Inhaled R940343 in Patients With Mild to Moderate Asthma. The randomized, double blind, placebo controlled study enrolled 301 patients in the United States and Canada.