> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/dose-range-finding-study-to-assess-efficacy-and-safety-of-bca6b71f-5bbc-44e0-b6e4-252cc8f2afd6 > Record changed: 2026-10-13 # Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids NCT06932263 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932263) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932263) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932263) Participants 540 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932263) Lead sponsor AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932263) Start date 2025-03-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932263) Number of sites 221 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932263) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932263) **Acronym** Umbriel Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932263) **Short title** Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932263) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932263) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932263) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932263) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932263) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932263) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932263) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932263) ## Dates **Completion date** 2028-02-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932263) **First posted** 2025-04-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932263) **Registry last updated** 2026-07-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932263) **Primary completion date** 2027-06-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932263) **Start date** 2025-03-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932263) ## Size and sites **Participants** 540 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932263) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932263) **Planned participants** 540 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932263) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932263) **Number of sites** 221 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932263) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932263) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932263) **Lead sponsor** AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932263) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932263) ## Identifiers **Registry ID** NCT06932263 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932263) **ClinicalTrials.gov ID** NCT06932263 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932263) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932263) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932263) ## Outcomes ### Primary outcomes 1. Annualised rate of severe asthma exacerbations Timeframe: Over 26 to 52 weeks 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. ### Secondary outcomes 1. Annualised rate of severe asthma exacerbations Timeframe: Over 26 to 52 weeks 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. 2. Time to first severe asthma exacerbation Timeframe: Over 26 to 52 weeks To evaluate the effect of two dose levels of tozorakimab compared to placebo on time to first severe asthma exacerbations. 3. Change from baseline in pre-bronchodilator forced expiratory volume in 1 second (FEV1) Timeframe: Over weeks 20 to 26 Difference in mean change from baseline between tozorakimab and placebo. 4. Change from baseline in post-bronchodilator FEV1 Timeframe: At week 26 Difference in mean change from baseline between tozorakimab and placebo. 5. Change from baseline in the Asthma Control Questionnaire 6 (ACQ-6) Timeframe: At week 26 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. 6. Change from baseline in the Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ12+) Timeframe: At week 26 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. 7. Trough serum concentrations of tozorakimab Timeframe: Over 52 weeks Pharmacokinetics: concentrations of tozorakimab in trough serum. 8. Anti-drug antibody incidence Timeframe: Over 52 weeks Immunogenicity: Number of Participants With Positive Antibodies to tozorakimab Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932263) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932263) ## Sites - Research SiteBakersfield, United StatesRecruiting - Research SiteHuntington Beach, United StatesWithdrawn - Research SiteLa Mesa, United StatesTerminated - Research SiteLoma Linda, United StatesWithdrawn - Research SiteLong Beach, United StatesWithdrawn - Research SiteNewport Beach, United StatesRecruiting - Research SiteSan Jose, United StatesRecruiting - Research SiteWilmington, United StatesTerminated - Research SiteCutler Bay, United StatesSuspended - Research SiteHialeah, United StatesSuspended - Research SiteLeesburg, United StatesWithdrawn - Research SiteMiami, United StatesSuspended - Research SiteMiami, United StatesSuspended - Research SiteMiami Lakes, United StatesSuspended - Research SiteOrlando, United StatesSuspended - Research SitePalmetto Bay, United StatesSuspended - Research SiteTampa, United StatesSuspended - Research SiteWinter Park, United StatesSuspended - Research SiteBoise, United StatesWithdrawn - Research SiteNoblesville, United StatesRecruiting - Research SiteWest Des Moines, United StatesTerminated - Research SiteHutchinson, United StatesNot yet recruiting - Research SiteKansas City, United StatesWithdrawn - Research SiteLouisville, United StatesRecruiting - Research SiteWhite Marsh, United StatesWithdrawn And 196 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932263) ## References ### Other registry identifiers - 2024-519116-14-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932263) ## Related records ### Drugs (1) - [Tozorakimab](https://trialight.com/data/asset/tozorakimab-2f585124-3232-4184-a7a4-ad2b7db2f5dd.md) ### Lead sponsors (1) - [AstraZeneca](https://trialight.com/data/company/astrazeneca-347ee8c0-c709-4614-b67b-0061b353dff7.md) ### Conditions (1) - [Asthma](https://trialight.com/data/condition/asthma-247437fb-0e60-5885-8a3a-ce40099cea88.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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