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NCT05251259 · ClinicalTrials.gov registry record · Phase 2
Study to Assess the Efficacy and Safety of Atuliflapon in Moderate-to-Severe Uncontrolled Asthma
A Phase 2 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 2
- Development phase
- 670
- Enrollment target
NCT05251259: Completed Phase 2 study, sponsored by AstraZeneca.
NCT05251259 is a Phase 2 study that has completed, run by AstraZeneca. The registered enrollment target is 670 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (404% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05251259, a Phase 2 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 670 participants
- Enrollment target
Study Summary
This is a randomised, placebo-controlled, double-blind study to assess the efficacy and safety of Atuliflapon administered once daily over a 12-week treatment period to adult participants with moderate to severe uncontrolled asthma.
Primary Outcome
The clinical efficacy of Atuliflapon Dose A will be assessed by calculating a Hazard Ratio between the treatment arms, Atuliflapon Dose A vs. placebo, in a selected population (based on biomarker level). CompEx Asthma, a novel composite endpoint for exacerbations, captures asthma-worsening episodes based on a combination of diary events (worsening in daily peak expiratory flow (PEF), asthma symptoms and reliever medication use) plus severe asthma exacerbation events.
Interventions
- DRUG Placebo
- DRUG Atuliflapon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 670 participants |
| Start Date | 2022-01-27 |
| Est. Completion | 2026-01-07 |
| Phase | Phase 2 |
What the finished NCT05251259 record still lists
NCT05251259 is an interventional study that assigns participants to a tested intervention. The registered 670 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 (404% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05251259 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05251259 about?
NCT05251259 is a clinical study titled "Study to Assess the Efficacy and Safety of Atuliflapon in Moderate-to-Severe Uncontrolled Asthma". This is a randomised, placebo-controlled, double-blind study to assess the efficacy and safety of Atuliflapon administered once daily over a 12-week treatment period to adult participants with moderate to severe uncontrolled asthma.
What is the current status of trial NCT05251259?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 670 participants. The study started on 2022-01-27. Estimated completion is 2026-01-07.
What interventions are being tested in trial NCT05251259?
The interventions under investigation include: Placebo (DRUG), Atuliflapon (DRUG).
Who is sponsoring clinical trial NCT05251259?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05251259's enrollment target sits among peer trials
670 48th of 2000 higher than 1,953 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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