NCT06932263ClinicalTrials.gov

Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids

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

RecruitingTaking participants now, according to the registry record.

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In brief

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.

Phase 2540 participants sought221 sites21 countries

Registered in 1 registry

ClinicalTrials.govNCT06932263Open this record at ClinicalTrials.govSynced 2 months ago

One study can be registered in several registries. We show it once and link every record we hold.

Trial information is shown as published by the registry, in its original language.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Not stated: Registered after enrolment began (about 22 days after the recorded start)First posted 2025-04-17; recorded start 2025-03-26
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Present: Participants are randomly assignedAllocation is recorded as randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Present: Uses blinding (masking)A masking level is recorded in the record
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 1019 other studies in this databaseCounted from the lead sponsor named in the record (AstraZeneca)
Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database

The record lists 1 condition.
Lead sponsor type recorded as: industry.
Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourDEFINITIVE

A definitive-grade design for a phase 2 study, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation20/20
Participants are randomly allocated between arms
Blinding20/20
Quadruple-blind
Control arm13/15
Placebo / sham control arm
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type3/10
Surrogate or intermediate endpoint (conservative default)
Multi-centre8/8
Multi-centre: 221 sites
Data monitoring committee7/7
A data monitoring committee is in place
Prospective registration3/5
Registered within 30 days of the study start
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleMEDIUM

A medium-sized study, international in scope: 540 participants (target), run at 221 sites, across 21 countries.

How this score is built

Enrolment27/40
540 participants (target)
Site count25/25
221 sites
Country count15/15
21 countries
Planned duration8/10
Planned over about 36 months
Sponsor scale10/10
AstraZeneca has led 991 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Summary

Conditions

Asthma

Eligibility

Eligibility
Sex	All
Ages	18 Years – 75 Years
Healthy volunteers	No

Eligibility as written in the registry

Inclusion Criteria: 1. Provision of signed and dated written informed consent prior to any study-specific procedures. 2. Adults aged 18-75, inclusive when signing the informed consent. 3. Documented physician-diagnosis of asthma for at least 12 months. 4. Treated with medium or high dose ICS in combination with LABA. 5. Demonstration of uncontrolled asthma through ACQ-6 score ≥ 1.5 . 6. Pre-bronchodilator FEV1 ≥ 40% to ≤ 90% of predicted normal. 7. Documented exacerbation history in the last 12 months and biomarker requirements of: 1. 2 severe exacerbations OR 2. 1 severe exacerbation and: (i) Eosinophils ≥ 150 cells/µl or (ii) FeNo ≥ 25 ppb 8. Participants need to demonstrate a ≥70% compliance for Asthma Daily Diary. 9. Women of Child Bearing Potential (WOCBP) must have a negative pregnancy test. 10. Contraceptive use by males and females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Exclusion Criteria: 1. Completed treatment for respiratory infection with antibiotics in the 4 weeks prior to Visit 1. 2. Clinically significant pulmonary disease other than asthma . 3. Current smokers, former smokers with \>10 pack-years history. 4. Clinically significant aortic stenosis or pulmonary arterial hypertension. 5. Active tuberculosis, hepatitis, HIV, or current diagnosis of cancer or immune complex disease. 6. Unstable cardiovascular disorders.

Eligibility in plain statements

This record's criteria have not been broken into separate statements yet. The registry text above is complete and is the authoritative version.

Study design

Study design
Study type	Interventional
Phase	Phase 2
Allocation	Randomised
Intervention model	PARALLEL
Primary purpose	TREATMENT
Masking	QUADRUPLE (4)
Enrolment	540 participants sought

Sponsor and collaborators

AstraZeneca Sponsor

Arms and interventions

Tozorakimab Dose 1EXPERIMENTAL
Dosing subcutaneously tozorakimab Dose 1
Tozorakimab Dose 2EXPERIMENTAL
Dosing subcutaneously tozorakimab Dose 2 and placebo
PlaceboPLACEBO_COMPARATOR
Dosing subcutaneously with equivalent volume to tozorakimab

Interventions

Drug Placebo
Placebo will be administered subcutaneously.
Drug Tozorakimab
The drug will be administered subcutaneously.

Outcome measures

Primary outcome
Annualised rate of severe asthma exacerbations
The rate ratio of severe asthma exacerbations will be assessed in the participants with uncontrolled moderate-to-severe asthma and ≥ 1 severe exacerbation within 12 months prior to screening.
Time frame Over 26 to 52 weeks
Secondary outcome
Annualised rate of severe asthma exacerbations
The rate ratio of severe asthma exacerbations will be assessed in the participants with uncontrolled moderate-to-severe asthma and baseline eosinophils \< 300 cells/µL and history of ≥2 severe exacerbations within 12 months prior to screening.
Time frame Over 26 to 52 weeks
Secondary outcome
Time to first severe asthma exacerbation
To evaluate the effect of two dose levels of tozorakimab compared to placebo on time to first severe asthma exacerbations.
Time frame Over 26 to 52 weeks
Secondary outcome
Change from baseline in pre-bronchodilator forced expiratory volume in 1 second (FEV1)
Difference in mean change from baseline between tozorakimab and placebo.
Time frame Over weeks 20 to 26
Secondary outcome
Change from baseline in post-bronchodilator FEV1
Difference in mean change from baseline between tozorakimab and placebo.
Time frame At week 26
Secondary outcome
Change from baseline in the Asthma Control Questionnaire 6 (ACQ-6)
Difference in mean change from baseline between tozorakimab and placebo. The ACQ-6 has 6 questions (regarding asthma symptoms and rescue bronchodilator use). Answering the questions results in a score out of 6. A Score of 0 indicates complete control and 6 reflects severely uncontrolled disease.
Time frame At week 26
Secondary outcome
Change from baseline in the Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ12+)
Difference in mean change from baseline between tozorakimab and placebo. The AQLQ12+ includes 32 questions grouped into four domains: symptoms; activity limitations; emotional function; and, environmental stimuli. Each question is scored on a seven-point Likert scale, which ranges from 7 (no impairment) to 1 (severe impairment). The overall score is calculated as the mean of all questions, and the four domain scores are the means of the scores for the questions in the respective domains.
Time frame At week 26
Secondary outcome
Trough serum concentrations of tozorakimab
Pharmacokinetics: concentrations of tozorakimab in trough serum.
Time frame Over 52 weeks
Secondary outcome
Anti-drug antibody incidence
Immunogenicity: Number of Participants With Positive Antibodies to tozorakimab
Time frame Over 52 weeks

Dates

Dates
Start date	March 26, 2025 (actual)
Primary completion	June 7, 2027 (estimated)
Completion	February 28, 2028 (estimated)
First posted	April 17, 2025 (actual)
Last updated	July 20, 2026
Results posted	Not stated in the registry record
Status last verified	July 2026

Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.

Locations

150 sites are recruiting

Argentina

Argentina
Facility	City	Status
Research Site	CABA	Recruiting
Research Site	Ciudad de Buenos Aires	Withdrawn
Research Site	Ciudad de Buenos Aires	Recruiting
Research Site	La Plata	Recruiting
Research Site	Mendoza	Recruiting
Research Site	Rosario	Recruiting
Research Site	San Miguel de Tucumán	Recruiting

Brazil

Brazil
Facility	City	Status
Research Site	Caxias do Sul	Withdrawn
Research Site	Criciúma	Recruiting
Research Site	Porto Alegre	Recruiting
Research Site	Porto Alegre	Recruiting
Research Site	Salvador	Withdrawn
Research Site	Santo André	Withdrawn
Research Site	Sorocaba	Recruiting
Research Site	São José do Rio Preto	Recruiting
Research Site	São Paulo	Recruiting
Research Site	São Paulo	Recruiting

Chile

Chile
Facility	City	Status
Research Site	Curicó	Active, not recruiting
Research Site	Quillota	Active, not recruiting
Research Site	Santiago	Active, not recruiting
Research Site	Santiago	Active, not recruiting
Research Site	Santiago	Active, not recruiting
Research Site	Temuco	Active, not recruiting
Research Site	Viña del Mar	Active, not recruiting

China

China
Facility	City	Status
Research Site	Baotou	Recruiting
Research Site	Changchun	Recruiting
Research Site	Chengdu	Recruiting
Research Site	Chongqing	Recruiting
Research Site	Guangzhou	Recruiting
Research Site	Haikou	Recruiting
Research Site	Hefei	Recruiting
Research Site	Hohhot	Recruiting
Research Site	Huizhou	Recruiting
Research Site	Qingdao	Recruiting
Research Site	Shanghai	Recruiting
Research Site	Shanghai	Recruiting
Research Site	Shanghai	Recruiting
Research Site	Shenzhen	Recruiting
Research Site	Wenzhou	Recruiting
Research Site	Xuzhou	Recruiting

France

France
Facility	City	Status
Research Site	Brest	Recruiting
Research Site	Créteil	Recruiting
Research Site	Lyon	Recruiting
Research Site	Marseille	Recruiting
Research Site	Pessac	Recruiting
Research Site	Strasbourg	Recruiting
Research Site	Suresnes	Recruiting

Greece

Greece
Facility	City	Status
Research Site	Athens	Recruiting
Research Site	Athens	Recruiting
Research Site	Ioannina	Withdrawn

171 further sites are listed in the registry record.

Study documents

No documents are linked in this registry record.

Changes over time

No changes have been recorded since we first ingested this record.

A change is recorded each time the sponsor updates the registry record. Status, dates, enrolment and sites appear here as they move.

Registry: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT06932263

Categories

Registered in 1 registry

Interested in this study?

How this study is set up

Summary

Conditions

Eligibility

Eligibility as written in the registry

Eligibility in plain statements

Study design

Sponsor and collaborators

Arms and interventions

Interventions

Outcome measures

Dates

Locations

Argentina

Brazil

Chile

China

France

Greece

Study documents

Changes over time