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NCT04946318 · ClinicalTrials.gov registry record · Phase 2
Study of Safety of CSJ117 in Participants With Moderate to Severe Uncontrolled Asthma
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 136
- Enrollment target
NCT04946318: Clinical Trial Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT04946318 is a Phase 2 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 136 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04946318, a Phase 2 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 136 participants
- Enrollment target
Study 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).
Primary Outcome
Number of treatment emergent AEs, AEs leading to study treatment discontinuation, SAEs and SAEs leading to study treatment discontinuation. Treatment emergent AEs and SAEs will be counted from first day of treatment of the core study (CCSJ117A12201C) and until 30 days after last day of treatment in the extension study. For participants who will enter the extension study after the last follow-up visit (week 24) of the core study, AEs (if any) occurring from week 4 to week 12 of the drug free fol
Interventions
- DRUG Placebo
- DRUG CSJ117
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 136 participants |
| Start Date | 2021-09-08 |
| Est. Completion | 2022-09-08 |
| Phase | Phase 2 |
Why NCT04946318 stopped before completion
NCT04946318 is an interventional study that assigns participants to a tested intervention. The registered 136 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04946318 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04946318 about?
NCT04946318 is a clinical study titled "Study of Safety of CSJ117 in Participants With Moderate to Severe Uncontrolled Asthma". 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 (addit...
What is the current status of trial NCT04946318?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 136 participants. The study started on 2021-09-08. Estimated completion is 2022-09-08.
What interventions are being tested in trial NCT04946318?
The interventions under investigation include: Placebo (DRUG), CSJ117 (DRUG).
Who is sponsoring clinical trial NCT04946318?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04946318's enrollment target sits among peer trials
136 527th of 2000 higher than 1,469 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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