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Ciclesonide

Phase 3

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials3
Total Enrollment1,614
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00174720Efficacy of Ciclesonide vs Placebo Administered as Once Daily or Twice Daily in Patients Not Treated With Inhaled Corticosteroid.PHASE3 COMPLETED 708Sep 1, 2005Feb 1, 2007Apr 8, 200911 United States, Brazil +9
NCT00174733Efficacy of Ciclesonide Versus Placebo Administered Either as Once Daily or Twice Daily in Patients Treated Previously With an Inhaled CorticosteroidPHASE3 COMPLETED 456Jul 1, 2005Feb 1, 2006Apr 8, 20091 United States
NCT00270348Effects of Ciclesonide MDI 50mg/Day and 200mg/Day (Ex-Valve) Once-Daily on Growth in Children With Mild Persistent AsthmaPHASE3 COMPLETED 450Dec 1, 2000Sep 1, 2004Dec 28, 2005 -
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Study Endpoints
Primary Endpoints
Change from baseline to Week 16 in FEV1
Change from baseline to Week 12 in FEV1
Subject's height measured w. standard stadiometry techniques. 4 acceptable serial measurements taken at each visit on same equipment by a qualified technician.Median of 4 measurements used the subject's stadiometer height data
Secondary Endpoints
Symptom scores, rescue albuterol use and morning peak flow measurements
Blinded assessment of bone age according to Greulich and Pyle radiographic atlas with wrist X-rays. Subjects monitored for AEs and any events occurring during study. Pulmonary function tests performed to measure FEV1 in liters and % of predicted FEV1
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
Ciclesonide (XRP1526)DRUG -
ciclesonideDRUG -
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Eligibility Criteria
Age Range12 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: * Males or females 12 years or older * History of persistent bronchial asthma for at least 6 months * Documented use of bronchodilators (short acting only) only or methylxanthines for at least 1 month before screening * At screening, FEV1 60 to 90% of predicted. Reversibility of...

Countries:United StatesBrazilChileCosta RicaEstoniaIsraelLatviaMexicoPolandPuerto RicoRussia
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