Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING Phase 3

Efficacy and Safety of Tozorakimab in Symptomatic Chronic Obstructive Pulmonary Disease With a History of Exacerbations.

NCT05158387 · View on ClinicalTrials.gov ↗

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.

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

1,053 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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,172 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,053 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05158387 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Florida, California, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05158387?

The interventions under investigation include: Placebo (DRUG), Tozorakimab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05158387?

This trial is sponsored by AstraZeneca, which has 1,053 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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