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NCT06040086 · 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
1,454
Enrollment target
20
Study locations

NCT06040086: Active Phase 3 study of Chronic Obstructive Pulmonary Disease (COPD), sponsored by AstraZeneca.

NCT06040086 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 1,454 participants, above the 611-participant average among 36 other Chronic Obstructive Pulmonary Disease (COPD) trials with a reported enrollment target (138% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06040086, 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
1,454 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this Phase III study is to evaluate the efficacy and safety of tozorakimab administered subcutaneously (SC) in adult participants with symptomatic COPD with a history of ≥ 2 moderate or ≥ 1 severe exacerbations of COPD in the 12 months prior to enrolment. Participants should be receiving optimised treatment with inhaled maintenance therapy (ICS/LABA/LAMA triple therapy, or dual therapy if triple is not considered appropriate) throughout at least the last 3 months prior to enrolment.

Primary Outcome

The primary endpoint will be assessed in the primary population (former smokers with symptomatic COPD and a history of exacerbations, on optimised treatment with maintenance inhaled therapy \[triple therapy, or dual therapy if triple is not considered appropriate\]).

Interventions

  • DRUG Placebo
  • DRUG Tozorakimab

Study Locations (20)

Florida

  • Research Site - Boynton Beach
  • Research Site - Cape Coral
  • Research Site - Lakeland
  • Research Site - Lakeland
  • Research Site - Naples
  • Research Site - Ocala
  • Research Site - Ormond Beach

California

  • Research Site - Los Angeles
  • Research Site - Newport Beach
  • Research Site - San Francisco
  • Research Site - Westminster

Alabama

  • Research Site - Birmingham
  • Research Site - Decatur
  • Research Site - Sheffield

Arizona

  • Research Site - Phoenix
  • Research Site - Tucson
  • Research Site - Yuma

Colorado

  • Research Site - Aurora
  • Research Site - Boulder

District of Columbia

  • Research Site - Washington D.C.

Trial Details

FieldValue
Enrollment Target 1,454 participants
Start Date 2023-09-22
Est. Completion 2026-05-22
Phase Phase 3
AstraZeneca

1,285 total trials

What the registry record for NCT06040086 still lists

NCT06040086 is an interventional study that assigns participants to a tested intervention. Its 1,454 participants enrollment target places it among the larger protocols in the corpus, above the 611-participant average among 36 other Chronic Obstructive Pulmonary Disease (COPD) trials with a reported enrollment target (138% 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.

NCT06040086 names 20 study sites across 6 states, led by Florida, California, Alabama.

Frequently Asked Questions

What is clinical trial NCT06040086 about?

NCT06040086 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 administered subcutaneously (SC) in adult participants with symptomatic COPD with a history of ≥ 2 moderate or ≥ 1 severe exacerbations of COPD in the 12 months prior to enrolment. Participants should be receiv...

What is the current status of trial NCT06040086?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,454 participants. The study started on 2023-09-22. Estimated completion is 2026-05-22.

What conditions does trial NCT06040086 study?

This clinical trial studies the following conditions: Chronic Obstructive Pulmonary Disease (COPD).

What interventions are being tested in trial NCT06040086?

The interventions under investigation include: Placebo (DRUG), Tozorakimab (DRUG).

Who is sponsoring clinical trial NCT06040086?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06040086 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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 NCT06040086's enrollment target sits among peer trials

1,454 4th of 36 higher than 33 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

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Source: ClinicalTrials.gov NCT06040086, the US trial registry maintained by the National Library of Medicine. NCT06040086 (large enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.