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R940343

Phase 2

Asthma | Small molecule | Respiratory |Rigel Pharmaceuticals, Inc.|Last 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

Clinical trial landscape

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 used for in asthma?

R940343 is an investigational small molecule being studied for the treatment of mild to moderate asthma. It is administered via inhalation. The drug is currently in Phase 2 clinical development and is not approved by regulatory authorities.

Who makes R940343?

R940343 is being developed by Rigel Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol RIGL. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug.

What phase is R940343 in?

R940343 is in Phase 2 clinical development. It has completed one Phase 2 trial, which was a randomized, double-blind, placebo-controlled study. The drug remains investigational and has not received regulatory approval for any use.

What clinical trials is R940343 in?

R940343 has been studied in one completed Phase 2 clinical trial, identified as NCT01591044. This trial was a safety and efficacy study of inhaled R940343 in patients with mild to moderate asthma, enrolling 301 participants in the United States and Canada.

Is R940343 the same as any other drug?

R940343 is the primary name for this investigational drug. No alternative names have been reported in clinical trial records. It is a small molecule developed by Rigel Pharmaceuticals for the treatment of asthma.