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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 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.

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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.

Conditions Studied

Chronic Obstructive Pulmonary Disease (COPD)

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

FieldValue
Enrollment Target 1,172 participants
Start Date 2022-02-07
Est. Completion 2026-03-23
Phase Phase 3

Sponsor

AstraZeneca

1,285 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05158387

The ClinicalTrials.gov registry entry for NCT05158387 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 1,172 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 619-participant average among 36 other Chronic Obstructive Pulmonary Disease (COPD) trials with a reported enrollment target (89% higher). The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.