Study of Safety of CSJ117 in Participants With Moderate to Severe Uncontrolled Asthma

• Status: Recruiting
• Trial end date: 2023-06-05
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to provide safety and tolerability, pharmacokinetics and immunogenicity data for multiple CSJ117 doses inhaled once daily compared with placebo, in adult asthma participants treated with medium or high dose ICS plus LABA alone or with additional asthma controllers (additional controllers allowed: LTRA, LAMA, Theophylline and its derivatives), who have completed the prior phase llb study CCSJ117A12201C (NCT04410523).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

Inclusion Criteria:

• All participants must have been treated with a fixed dose combination of fluticasone propionate/salmeterol in one of two doses in stable dose alone or with additional controllers at label approved dosage (allowed only: LTRA, LAMA, Theophylline or its derivatives).

• Participants completing the Treatment period and Follow-up period of study CSJ117A12201C and continuing with study CCSJ117A12201E1 must have completed the Treatment period of CSJ117A12201C (i.e. did not discontinue blinded study treatment prematurely) and Follow-up period of study CSJ117A12201C.

Exclusion Criteria:

• Participants who were enrolled into prior study CSJ117A12201C and developed a significant and/or permanent health condition during the prior study.

• Participants who experienced a serious and drug-related AE in the prior study CSJ117A12201C.

• Participants receiving any prohibited medications.

• Participants with a history or current diagnosis of ECG abnormalities.

• Pregnant or nursing (lactating) women.