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Taking peoplePhase 2

Tests tozorakimab for uncontrolled asthma in adults using inhaled steroids

Tests tozorakimab injections against placebo in adults with uncontrolled asthma.

Key facts

Who runs it
AstraZeneca
Where
Catania, Foggia, Genoa, and Rome, ItalySee the 4 sitesAlso in 20 other countries, 190 sites
Registry title
Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids
Status
Recruiting
Phase
Phase 2
People taking part
540 people, planned
Started
26 Mar 2025
Expected to end
28 Feb 2028
Type of study
Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Tozorakimab
  • Placebo
Record updated
30 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18-75 whose asthma is not well controlled while on medium or high dose inhaled steroids with a LABA.

Age
18 to 75 years
Sex
All sexes
Disease stage
Asthma diagnosed by a doctor for at least 12 months and not well controlled (ACQ-6 score ≥ 1.5). Lung function (pre-bronchodilator FEV1) must be ≥ 40% to ≤ 90% of predicted normal.
Earlier treatment
Must be treated with medium or high dose ICS (inhaled corticosteroid) together with LABA.
Biomarker or test result
Asthma attacks (exacerbations) in the last 12 months: ≥ 2 severe ones, OR 1 severe one plus eosinophils ≥ 150 cells/µl or FeNo ≥ 25 ppb.

Main reasons for not taking part

  • Antibiotics for a respiratory infection in the 4 weeks before Visit 1
  • Clinically significant lung disease other than asthma
  • Current smokers, or former smokers with >10 pack-years
  • Active tuberculosis, hepatitis or HIV, or current cancer or immune complex disease
  • Unstable heart or circulation disorders, significant aortic stenosis or pulmonary arterial hypertension

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • Provision of signed and dated written informed consent prior to any study-specific procedures
  • Adults aged 18-75, inclusive when signing the informed consent
  • Documented physician-diagnosis of asthma for at least 12 months
  • Treated with medium or high dose ICS in combination with LABA
  • Demonstration of uncontrolled asthma through ACQ-6 score ≥ 1.5
  • Pre-bronchodilator FEV1 ≥ 40% to ≤ 90% of predicted normal
  • Documented exacerbation history in the last 12 months and biomarker requirements of:; ≥ 2 severe exacerbations OR; 1 severe exacerbation and:; (i) Eosinophils ≥ 150 cells/µl or (ii) FeNo ≥ 25 ppb
  • Participants need to demonstrate a ≥70% compliance for Asthma Daily Diary
  • Women of Child Bearing Potential (WOCBP) must have a negative pregnancy test
  • Contraceptive use by males and females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies

Who cannot take part

  • Completed treatment for respiratory infection with antibiotics in the 4 weeks prior to Visit 1
  • Clinically significant pulmonary disease other than asthma
  • Clinically significant aortic stenosis or pulmonary arterial hypertension
  • Active tuberculosis, hepatitis, HIV, or current diagnosis of cancer or immune complex disease
  • Unstable cardiovascular disorders
  • Current smokers, former smokers with >10 pack-years history

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

Where in Italy

Also in 20 other countries, 190 sites

  • Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di CataniaCatania, ItalyNo longer taking part
  • Azienda Ospedaliero Universitaria Ospedali RiunitiFoggia, ItalyNo longer taking part
  • IRCCS Ospedale Policlinico San MartinoGenoa, ItalyNo longer taking part
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyNo longer taking part

About the trial

What the trial wants to find out

This is a dose-range finding, double-blind, placebo-controlled, phase IIb study designed to assess efficacy and safety of tozorakimab administered subcutaneously in adult participants with uncontrolled asthma receiving medium-to-high dose inhaled corticosteroids.

The 3 groups in the trial

  • Tozorakimab Dose 1Treatment being tested

    Dosing subcutaneously tozorakimab Dose 1

    Treatment: Tozorakimab

  • Tozorakimab Dose 2Treatment being tested

    Dosing subcutaneously tozorakimab Dose 2 and placebo

    Treatment: Tozorakimab

  • PlaceboPlacebo, for comparison

    Dosing subcutaneously with equivalent volume to tozorakimab

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Phase IIb, Multicentre, Double-blind, Placebo-controlled Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adult Participants With Uncontrolled Asthma on Medium-to High Dose Inhaled Corticosteroids
Plain-language title
Tests tozorakimab for uncontrolled asthma in adults using inhaled steroidsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06932263, who can take part
Record updated
30 October 2026