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AVE2635A

Phase 2

Asthma | Small molecule | Respiratory |Sanofi|Last Updated: Apr 8, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment1,145

FDA Designations

No designations recorded

Clinical trial landscape

AVE2635A · 1 trial · 1 indication

Phase 2 1
NCT00174746Dose Response Study of Inhaled Ciclesonide (Glucocorticosteroid) to Patients With Persistent AsthmaAsthma
COMPLETED1,145 Analytics
PHASE2COMPLETED
Dose Response Study of Inhaled Ciclesonide (Glucocorticosteroid) to Patients With Persistent Asthma
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

Primary endpoint will be the change from baseline to week 6 in FEV1

Secondary Endpoints

PK parameters measured after 4 weeks of treatment. Change from baseline in serum cortisol pre-and post ACTH stimulation, AM and PM peak expiratory flow rates, AM and PM asthma symptoms, and albuterol use after 6 weeks of treatment.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
AVE2635ADRUG -
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Eligibility Criteria

Age Range12 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Males or females 12 years or older; History of persistent bronchial asthma for at least 6 months; Documented use of an inhaled steroid for at least 1 month before screening; At screening, FEV1 40% or more of predicted normal and at randomization, FEV1 between 40 and 80% predic...

Countries:United States
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Frequently asked questions about AVE2635A

What is AVE2635A used for in asthma?

AVE2635A is an investigational small molecule being studied for the treatment of asthma. It is currently in Phase 2 clinical development. The drug is being evaluated in patients with persistent asthma to assess its efficacy and safety. AVE2635A is not yet approved and remains under clinical investigation.

What does AVE2635A target?

The specific molecular target of AVE2635A has not been disclosed in available information. The drug is being studied for its potential role in treating asthma, but its mechanism of action is not publicly detailed. Further research and clinical data may clarify how AVE2635A works.

Who makes AVE2635A?

AVE2635A is being developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is conducting clinical trials to evaluate the drug's safety and efficacy in patients with asthma. The drug is currently in Phase 2 development.

What phase is AVE2635A in?

AVE2635A is currently in Phase 2 clinical development for the treatment of asthma. It is an investigational drug and has not received regulatory approval. The Phase 2 trial has been completed, and the drug is not yet available for commercial use.

What clinical trials is AVE2635A in?

AVE2635A has one completed clinical trial registered under NCT00174746, titled 'Dose Response Study of Inhaled Ciclesonide (Glucocorticosteroid) to Patients With Persistent Asthma.' This Phase 2 study enrolled 1,145 participants with asthma in the United States. The trial was randomized, double-blind, and uncontrolled.

Is AVE2635A the same as ciclesonide?

AVE2635A is associated with a clinical trial that studied inhaled ciclesonide, a glucocorticosteroid, in patients with persistent asthma. However, AVE2635A is the investigational drug name used in the trial. The relationship between AVE2635A and ciclesonide is not explicitly clarified in available data.