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Monoclonal Antibodies

CSJ117 for 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 participants entering directly after completion of study treatment of core study: weeks 2, 4, 8, 12, 14, 16, 20, 24, 26, 28 and 36; participants entering directly after completion of the core study follow-up period: weeks 2, 4, 8, 12, 14, 16 and 24.
Awards & highlights

Summary

This trial tests the safety and effectiveness of an inhaled medication called CSJ117 in adult asthma patients who are already on strong asthma treatments. The study will see how well the body handles the drug and if it causes any immune reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~participants entering directly after completion of study treatment of core study: weeks 2, 4, 8, 12, 14, 16, 20, 24, 26, 28 and 36; participants entering directly after completion of the core study follow-up period: weeks 2, 4, 8, 12, 14, 16 and 24.
This trial's timeline: 3 weeks for screening, Varies for treatment, and participants entering directly after completion of study treatment of core study: weeks 2, 4, 8, 12, 14, 16, 20, 24, 26, 28 and 36; participants entering directly after completion of the core study follow-up period: weeks 2, 4, 8, 12, 14, 16 and 24. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of treatment emergent adverse events (AEs) and serious adverse events (SAEs)
Number of treatment emergent participant deaths and participant hospitalizations
Secondary study objectives
CSJ117 serum concentration
Change from baseline in Anti-drug immune response
Change from baseline in Fractional exhaled Nitric Oxide (FeNO) levels
+2 more

Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: 24-week CSJ117Experimental Treatment1 Intervention
Participants who will enter the extension study after the last treatment visit (week 12) of the core study and will be treated once daily for 24 weeks with the same dose of CSJ117 they received in the core study. CSJ117 (0.5 mg, 1 mg, 2 mg, 4 mg and 8 mg) inhaled once daily for 24 weeks.
Group II: 12-week wash out + 12-week CSJ117Experimental Treatment1 Intervention
Participants who will enter the extension study after the last treatment visit (week 12) of the core study and will be treated with Placebo inhaled once daily for 12 weeks "washout period" and then they will be treated once daily for 12 weeks with the same dose of CSJ117 they received in the core study. CSJ117 (0.5 mg, 1 mg, 2 mg, 4 mg and 8 mg) inhaled once daily for 12 weeks.
Group III: 12-week CSJ117Experimental Treatment1 Intervention
Participants who will enter the extension study after the last follow-up visit (week 24) of the core study will be treated with once daily for 12 weeks with the same dose of CSJ117 they received in the core study. CSJ117 (0.5 mg, 1 mg, 2 mg, 4 mg and 8 mg) inhaled once daily for 24 weeks.
Group IV: 24-week PlaceboPlacebo Group2 Interventions
Participants who will enter the extension study after the last treatment visit (week 12) of the core study and will be treated with Placebo inhaled once daily for 24 weeks
Group V: 12-week wash out + 12-week PlaceboPlacebo Group1 Intervention
Participants who will enter the extension study after the last treatment visit (week 12) of the core study and will be treated with Placebo inhaled once daily for 12 weeks "washout period" and Placebo inhaled once daily for 12 weeks
Group VI: 12-week PlaceboPlacebo Group1 Intervention
Participants who will enter the extension study after the last follow-up visit (week 24) of the core study will be treated with Placebo inhaled once daily for 12 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CSJ117
2021
Completed Phase 2
~70

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,889 Previous Clinical Trials
4,201,868 Total Patients Enrolled
79 Trials studying Asthma
45,886 Patients Enrolled for Asthma
~34 spots leftby Sep 2025
Unbiased ResultsWe believe in providing patients with all the options.
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