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Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma

Phase 2
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 and week 12: pre-dose, 2 and 4 hours post-dose; weeks 2, 4 and 8: pre-dose and 4 hours post-dose; weeks 14, 16, 20 and 24: pre-dose

Summary

This trial is testing an inhaled medication called CSJ117 at different doses to help adults with uncontrolled asthma breathe better. The study aims to see if this new treatment can improve lung function and reduce asthma symptoms.

Eligible Conditions
  • Asthma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 and week 12: pre-dose, 2 and 4 hours post-dose; weeks 2, 4 and 8: pre-dose and 4 hours post-dose; weeks 14, 16, 20 and 24: pre-dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 and week 12: pre-dose, 2 and 4 hours post-dose; weeks 2, 4 and 8: pre-dose and 4 hours post-dose; weeks 14, 16, 20 and 24: pre-dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Average Change From Baseline in Pre-dose FEV1 at Week 8 and Week 12
Secondary study objectives
Average Change From Baseline in ACQ-5 Score at Week 8 and Week 12
Average Change From Baseline in AQLQ+12 Score at Week 8 and Week 12
Average Change From Baseline in FeNO at Week 8 and Week 12
+8 more

Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: CSJ117 8mgExperimental Treatment2 Interventions
CSJ117 8 mg inhaled once daily
Group II: CSJ117 4mgExperimental Treatment2 Interventions
CSJ117 4 mg inhaled once daily
Group III: CSJ117 2mgExperimental Treatment2 Interventions
CSJ117 2 mg inhaled once daily
Group IV: CSJ117 1mgExperimental Treatment2 Interventions
CSJ117 1 mg inhaled once daily
Group V: CSJ117 0.5mgExperimental Treatment2 Interventions
CSJ117 0.5 mg inhaled once daily
Group VI: PlaceboPlacebo Group2 Interventions
Placebo inhaled once daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
CSJ117
2021
Completed Phase 2
~70

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,916 Previous Clinical Trials
4,253,550 Total Patients Enrolled
79 Trials studying Asthma
45,687 Patients Enrolled for Asthma
~64 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
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