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

NCT05158387 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1172

Last updated 2026-04-16

No results posted yet for this 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

  • Chronic Obstructive Pulmonary Disease (COPD)

Interventions

DRUG

Tozorakimab

Administered subcutaneously tozorakimab Dose 1 and placebo through Week 52.

DRUG

Tozorakimab

Administered subcutaneously tozorakimab Dose 2 through Week 52.

DRUG

Placebo

Placebo administered subcutaneously, equivalent volume to tozorakimab through week 52.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-07
Primary Completion
2026-01-19
Completion
2026-03-22
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Brazil
  • Chile
  • China
  • Colombia
  • France
  • Germany
  • Greece
  • Israel
  • Italy
  • Peru
  • Philippines
  • Poland
  • Puerto Rico
  • Romania
  • Russia
  • Taiwan
  • Thailand
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05158387 on ClinicalTrials.gov