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NCT03706079 · ClinicalTrials.gov registry record · Phase 3
Extension Study to Evaluate the Safety and Tolerability of Tezepelumab in Adults and Adolescents With Severe, Uncontrolled Asthma
A Phase 3 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 951
- Enrollment target
NCT03706079: Completed Phase 3 study, sponsored by AstraZeneca.
NCT03706079 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 951 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (23% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03706079, a Phase 3 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 951 participants
- Enrollment target
Study Summary
Subjects who completed either D5180C00007 or D5180C00009 will be offered the opportunity to consent for the Multicentre, Double-blind, Randomized, Placebo Controlled, Parallel Group, Phase 3, Safety Extension Study to Evaluate the Safety and Tolerability of Tezepelumab in Adults and Adolescents with Severe Uncontrolled Asthma. The study consists of a treatment phase, followed by a follow-up phase where subjects will not receive IP. The length of the follow up phase is determined by which study the subject had previously completed.
Primary Outcome
Includes adverse events with an onset date between the date of first dose of IP in the predecessor and minimum (date of last dose of IP + 33 days, date of death, date of study withdrawal, day prior to start of another biologic). The analysis is based on the Safety Analysis Set. Exposure adjusted rates are defined as number of subjects with AEs divided by total time at risk across all subjects, multiplied by 100
Interventions
- OTHER Placebo
- BIOLOGICAL Tezepelumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 951 participants |
| Start Date | 2019-01-07 |
| Est. Completion | 2022-05-18 |
| Phase | Phase 3 |
What the finished NCT03706079 record still lists
NCT03706079 is an interventional study that assigns participants to a tested intervention. The registered 951 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (23% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03706079 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03706079 about?
NCT03706079 is a clinical study titled "Extension Study to Evaluate the Safety and Tolerability of Tezepelumab in Adults and Adolescents With Severe, Uncontrolled Asthma". Subjects who completed either D5180C00007 or D5180C00009 will be offered the opportunity to consent for the Multicentre, Double-blind, Randomized, Placebo Controlled, Parallel Group, Phase 3, Safety Extension Study to Evaluate the Safety and Tolerability of Tezepelumab in Adults and Adolescents with...
What is the current status of trial NCT03706079?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 951 participants. The study started on 2019-01-07. Estimated completion is 2022-05-18.
What interventions are being tested in trial NCT03706079?
The interventions under investigation include: Placebo (OTHER), Tezepelumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03706079?
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 NCT03706079's enrollment target sits among peer trials
951 333rd of 2000 higher than 1,668 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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