Study of safety of CSJ117 in participants with moderate to severe uncontrolled asthma

A 24-week, multicenter, randomized, double-blind, parallel-arm, placebo-controlled extension study to assess the safety of CSJ117, when added to existing standard of care asthma therapy in patients >=18 years of age who completed study CCSJ117A12201C

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031210301

Enrollment

Registered

2021-09-09

Start date

2021-09-08

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Interventions

CSJ117 or placebo administered once daily

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Participants completing the Treatment period of prior study and continuing with this study must have completed the Treatment period of prior study. 2. Participants completing the Treatment period and Follow-up period of prior study and continuing with this study must have completed the Treatment period of prior study and Follow-up period of the core study.

Exclusion criteria

Exclusion criteria: 1. Participants prematurely discontinued irrespective of the reason from the prior study. 2. Participants who were enrolled into prior study and developed a significant and/or permanent health condition during the prior study that would have excluded them from participation in that study.

Design outcomes

Primary

Measure	Time frame
Number of treatment emergent adverse events (AEs) and serious adverse events (SAEs)	—

Countries

Argentina, Belgium, Bulgaria, Canada, Czech Republic, France, Germany, Guatemala, Hungary, Italy, Japan, Korea, Latvia, Philippines, Poland, Russia, Slovakia, United states

Contacts

Public ContactHideki Maruyama

Novartis Pharma. K.K.

rinshoshiken.toroku@novartis.com+81-120-003-293

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026