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NCT05158387 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Tozorakimab in Symptomatic Chronic Obstructive Pulmonary Disease With a History of Exacerbations.
A Phase 3 study of Chronic Obstructive Pulmonary Disease (COPD), sponsored by AstraZeneca.
- Active
- Registry status
- Phase 3
- Development phase
- 1,172
- Enrollment target
- 20
- Study locations
NCT05158387: Active Phase 3 study of Chronic Obstructive Pulmonary Disease (COPD), sponsored by AstraZeneca.
NCT05158387 is a Phase 3 study of Chronic Obstructive Pulmonary Disease (COPD) that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 1,172 participants, above the 619-participant average among 36 other Chronic Obstructive Pulmonary Disease (COPD) trials with a reported enrollment target (89% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05158387, a Phase 3 study of Chronic Obstructive Pulmonary Disease (COPD), is active but no longer recruiting, sponsored by AstraZeneca.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,172 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this Phase III study is to evaluate the efficacy and safety of tozorakimab Dose 1 and Dose 2 administered subcutaneously (SC) in adult participants with symptomatic COPD and history of ≥ 2 moderate or ≥ 1 severe exacerbation of COPD in the previous 12 months. Participants should be receiving optimised treatment with maintenance inhaled therapy (ICS/LABA/LAMA triple therapy, or dual therapy if triple is not considered appropriate) in stable doses throughout at least 3 months prior to enrolment.
Primary Outcome
The primary endpoint will be assessed first in the primary population (former smokers with symptomatic COPD and a history of exacerbations, on optimised treatment with maintenance inhaled therapy \[triple therapy, or dual therapy if triple is not considered appropriate\]) and then assessed in the overall population of participants.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Tozorakimab
Study Locations (20)
Florida
- Research Site - Bay Pines
- Research Site - Cape Coral
- Research Site - Pensacola
- Research Site - Tampa
- Research Site - Winter Park
California
- Research Site - Lincoln
- Research Site - Newport Beach
- Research Site - Northridge
Michigan
- Research Site - Ann Arbor
- Research Site - Farmington Hills
- Research Site - Grand Rapids
Alabama
- Research Site - Sheffield
Colorado
- Research Site - Colorado Springs
Delaware
- Research Site - Newark
Georgia
- Research Site - Macon
Indiana
- Research Site - Greenwood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,172 participants |
| Start Date | 2022-02-07 |
| Est. Completion | 2026-03-23 |
| Phase | Phase 3 |
What the registry record for NCT05158387 still lists
NCT05158387 is an interventional study that assigns participants to a tested intervention. Its 1,172 participants enrollment target places it among the larger protocols in the corpus, above the 619-participant average among 36 other Chronic Obstructive Pulmonary Disease (COPD) trials with a reported enrollment target (89% higher).
The record links to 1 condition, with Chronic Obstructive Pulmonary Disease (COPD) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05158387 names 20 study sites across 12 states, led by Florida, California, Michigan.
Frequently Asked Questions
What is clinical trial NCT05158387 about?
NCT05158387 is a clinical study titled "Efficacy and Safety of Tozorakimab in Symptomatic Chronic Obstructive Pulmonary Disease With a History of Exacerbations.". The purpose of this Phase III study is to evaluate the efficacy and safety of tozorakimab Dose 1 and Dose 2 administered subcutaneously (SC) in adult participants with symptomatic COPD and history of ≥ 2 moderate or ≥ 1 severe exacerbation of COPD in the previous 12 months. Participants should be re...
What is the current status of trial NCT05158387?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,172 participants. The study started on 2022-02-07. Estimated completion is 2026-03-23.
What conditions does trial NCT05158387 study?
This clinical trial studies the following conditions: Chronic Obstructive Pulmonary Disease (COPD).
What interventions are being tested in trial NCT05158387?
The interventions under investigation include: Placebo (DRUG), Tozorakimab (DRUG).
Who is sponsoring clinical trial NCT05158387?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05158387 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Delaware, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Obstructive Pulmonary Disease (COPD)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05158387's enrollment target sits among peer trials
1,172 6th of 36 higher than 31 of 36 other Chronic Obstructive Pulmonary Disease (COPD) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Obstructive Pulmonary Disease (COPD) 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
-
Multi-Center Clean Air Randomized Controlled Trial in COPD
RECRUITING · Phase 3
-
A Study to Evaluate Astegolimab in Participants With Chronic Obstructive Pulmonary Disease
RECRUITING · Phase 3
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A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00007)
RECRUITING · Phase 3
-
A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00006)
RECRUITING · Phase 3
-
Efficacy and Safety of Tozorakimab in Symptomatic Chronic Obstructive Pulmonary Disease With a History of Exacerbations
ACTIVE NOT RECRUITING · Phase 3
-
Long-term Efficacy and Safety of Tozorakimab in Participants With Chronic Obstructive Pulmonary Disease With a History of Exacerbations (PROSPERO).
ACTIVE NOT RECRUITING · Phase 3
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