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Ciclesonide

Phase 3

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 Trials3
Total Enrollment1,614

FDA Designations

No designations recorded

Clinical trial landscape

Ciclesonide · 4 trials · 3 indications

Phase 3 4
NCT00174720Efficacy of Ciclesonide vs Placebo Administered as Once Daily or Twice Daily in Patients Not Treated With Inhaled Corticosteroid.Asthma
COMPLETED708 Analytics
NCT00174733Efficacy of Ciclesonide Versus Placebo Administered Either as Once Daily or Twice Daily in Patients Treated Previously With an Inhaled CorticosteroidAsthma
COMPLETED456 Analytics
NCT00254956Effects Of Ciclesonide And Beclomethasone On Lens Opacification In Adult Subjects With Moderate To Severe Persistent AsthmaRespiratory Tract Diseases
COMPLETED1,568 Analytics
NCT00270348Effects of Ciclesonide MDI 50mg/Day and 200mg/Day (Ex-Valve) Once-Daily on Growth in Children With Mild Persistent AsthmaAsthma
COMPLETED450 Analytics
PHASE3COMPLETED
Efficacy of Ciclesonide vs Placebo Administered as Once Daily or Twice Daily in Patients Not Treated With Inhaled Corticosteroid.
Asthma
NCT00174720708
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PHASE3COMPLETED
Efficacy of Ciclesonide Versus Placebo Administered Either as Once Daily or Twice Daily in Patients Treated Previously With an Inhaled Corticosteroid
Asthma
NCT00174733456
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PHASE3COMPLETED
Effects Of Ciclesonide And Beclomethasone On Lens Opacification In Adult Subjects With Moderate To Severe Persistent Asthma
Respiratory Tract Diseases
NCT002549561,568
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PHASE3COMPLETED
Effects of Ciclesonide MDI 50mg/Day and 200mg/Day (Ex-Valve) Once-Daily on Growth in Children With Mild Persistent Asthma
Asthma
NCT00270348450
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Study Endpoints

Primary Endpoints

Change from baseline to Week 16 in FEV1
Change from baseline to Week 12 in FEV1
The primary endpoint is the occurrence of a Class I lens event for nuclear (NO), cortical (C), or posterior subcapsular (P) lens opacification within 12 months.
A Class I lens event is defined as any of the following events in either eye:
- 1.Increase from baseline in LOCS III grade of ≥ 0.5 (NO), ≥ 0.8 (C), or ≥ 0.5 (P)
- 2.Cataract surgery
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
- 1.Change from baseline to Month 12 in LOCS III grade for (a) nuclear opalescence, (b) cortical opacity, and (c) posterior subcapsular opacity.
- 2.Occurrence within 12 months in either eye of a Class II lens event: Increase from baseline in LOCS III grade of ≥ 0.9 (NO), ≥ 1.5 (C), or ≥ 0.9 (P), or cataract surgery.
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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 to 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 RicoRussiaFrance
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Competitive Landscape -Asthma 76 trials

CompanyTickerTrialsLead PhaseDrugs
Teva Pharmaceutical Industries Limited Sponsored ADRTEVA4PHASE3Fp/ABS, ABS
Novartis AG Sponsored ADRNVS5PHASE3QVM149, Salmeterol Xinafoate/ Fluticasone Propionate
GSK plc Sponsored ADRGSK5PHASE3FF/UMEC/VI
Sanofi SA Sponsored ADRSNY7PHASE3Dupilumab
AstraZeneca PLCAZN27PHASE3Benralizumab
Generate Biomedicines, Inc.GENB3PHASE3GB-0895
Eli Lilly and CompanyLLY1PHASE2Brenipatide
Incyte CorporationINCY1PHASE2povorcitinib, ICS-LABA
Pfizer Inc.PFE1PHASE2PF-07275315
Kymera Therapeutics, Inc.KYMR1PHASE2KT-621
Arrowhead Pharmaceuticals, Inc.ARWR1PHASE2ARO-RAGE
Upstream Bio, Inc.UPB1PHASE2Verekitug
Sunshine Biopharma IncorporatedSBFM2PHASE3610
Amgen Inc.AMGN1PHASE1AMG 691
Apogee Therapeutics, Inc.APGE1PHASE1APG777
Celldex Therapeutics, Inc.CLDX1PHASE1CDX-622
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Frequently asked questions about Ciclesonide

What is Ciclesonide used for?

Ciclesonide is an investigational small molecule being developed by Sanofi for the treatment of asthma and respiratory tract diseases. It is a corticosteroid administered via inhalation. The drug is currently in Phase 3 clinical development, with completed trials evaluating its efficacy and safety in patients with asthma.

Who makes Ciclesonide?

Ciclesonide is being developed by Sanofi, a multinational pharmaceutical company traded on the stock exchange under the ticker symbol SNY. The drug is a small molecule in the respiratory therapeutic area, intended for the treatment of asthma and respiratory tract diseases.

What phase is Ciclesonide in?

Ciclesonide is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Multiple Phase 3 trials have been completed, studying the drug's efficacy and safety in patients with asthma and respiratory conditions.

What clinical trials is Ciclesonide in?

Ciclesonide has been studied in several completed Phase 3 clinical trials, including NCT00174720, NCT00174733, NCT00254956, and NCT00270348. These trials evaluated the drug's efficacy compared to placebo, its effects on lens opacification, and its impact on growth in children with asthma.

Is Ciclesonide the same as Alvesco?

Ciclesonide is the generic name for the medication marketed under the brand name Alvesco. It is an inhaled corticosteroid used for the maintenance treatment of asthma. The drug is being developed by Sanofi and has undergone Phase 3 clinical trials for asthma and respiratory tract diseases.