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NCT04570657 · ClinicalTrials.gov registry record · Phase 2
Study to Assess the Efficacy and Safety of MEDI3506 in Adults With Uncontrolled Moderate-to-severe Asthma
A Phase 2 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 2
- Development phase
- 250
- Enrollment target
NCT04570657: Completed Phase 2 study, sponsored by AstraZeneca.
NCT04570657 is a Phase 2 study that has completed, run by AstraZeneca. The registered enrollment target is 250 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04570657, a Phase 2 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 250 participants
- Enrollment target
Study Summary
Study D9181C00001 is a Phase II, randomised, double-blind, placebo-controlled, parallel group, proof of concept study to evaluate the efficacy, safety, pharmacokinetics (PK) and immunogenicity of MEDI3506 in adult participants with uncontrolled moderate to severe asthma on standard of care (SOC). Up to approximately 80 sites globally will participate in this study. Approximately 228 participants will be randomized to 3 treatment groups in a 1:1:1 ratio to receive MEDI3506 dose 1, MEDI3506 dose 2, or placebo.
Primary Outcome
In-clinic spirometry measurements were taken prior to the administration of bronchodilators. Baseline was the last measurement prior to first injection of investigational product (IP). The least squares (LS) means, LS mean differences and 80% confidence intervals (CIs), and one-sided p-value results were based on a mixed model repeated measures (MMRM). The model included fixed effects for baseline, background medication, geographic region, baseline inhaled corticosteroids (ICS) total daily dose
Interventions
- DRUG Placebo
- BIOLOGICAL MEDI3506
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2020-09-17 |
| Est. Completion | 2023-02-06 |
| Phase | Phase 2 |
What the finished NCT04570657 record still lists
NCT04570657 is an interventional study that assigns participants to a tested intervention. The registered 250 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 (88% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04570657 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04570657 about?
NCT04570657 is a clinical study titled "Study to Assess the Efficacy and Safety of MEDI3506 in Adults With Uncontrolled Moderate-to-severe Asthma". Study D9181C00001 is a Phase II, randomised, double-blind, placebo-controlled, parallel group, proof of concept study to evaluate the efficacy, safety, pharmacokinetics (PK) and immunogenicity of MEDI3506 in adult participants with uncontrolled moderate to severe asthma on standard of care (SOC). Up...
What is the current status of trial NCT04570657?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 250 participants. The study started on 2020-09-17. Estimated completion is 2023-02-06.
What interventions are being tested in trial NCT04570657?
The interventions under investigation include: Placebo (DRUG), MEDI3506 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04570657?
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 NCT04570657's enrollment target sits among peer trials
250 222nd of 2000 higher than 1,768 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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