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NCT04410523 · ClinicalTrials.gov registry record · Phase 2
Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 335
- Enrollment target
NCT04410523: Clinical Trial Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT04410523 is a Phase 2 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 335 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (152% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04410523, a Phase 2 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 335 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the efficacy and safety of multiple CSJ117 doses (0.5; 1; 2; 4 and 8 mg) inhaled once daily compared with placebo, when added to standard-of-care (SoC) asthma therapy in adult patients with uncontrolled asthma with respect to change from baseline in FEV1 at the end of 12 weeks of treatment.
Primary Outcome
FEV1 (forced expiratory volume in one second) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. Pre-dose FEV1 is defined as average of the two FEV1 measurements taken at approximately 45 minutes and 15 minutes prior to dosing. The baseline pre-dose FEV1 value is defined as the average of the values taken approximately 2 hours 45 minutes and 2 hours 15 minutes prior to the first dose of double-blind
Interventions
- DRUG Placebo
- DRUG CSJ117
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 335 participants |
| Start Date | 2020-09-09 |
| Est. Completion | 2022-09-06 |
| Phase | Phase 2 |
Why NCT04410523 stopped before completion
NCT04410523 is an interventional study that assigns participants to a tested intervention. The registered 335 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (152% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04410523 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04410523 about?
NCT04410523 is a clinical study titled "Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma". The purpose of this study is to determine the efficacy and safety of multiple CSJ117 doses (0.5; 1; 2; 4 and 8 mg) inhaled once daily compared with placebo, when added to standard-of-care (SoC) asthma therapy in adult patients with uncontrolled asthma with respect to change from baseline in FEV1 at ...
What is the current status of trial NCT04410523?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 335 participants. The study started on 2020-09-09. Estimated completion is 2022-09-06.
What interventions are being tested in trial NCT04410523?
The interventions under investigation include: Placebo (DRUG), CSJ117 (DRUG).
Who is sponsoring clinical trial NCT04410523?
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 NCT04410523's enrollment target sits among peer trials
335 142nd of 2000 higher than 1,858 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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