AstraZeneca Initiates Phase IIb Trial of Tozorakimab for Adults with Asthma Inadequately Controlled on Medium-to-High-Dose Inhaled Corticosteroids

Data from the Drug Clinical Trial Registration and Information Disclosure Platform shows that a multicenter, double-blind, placebo-controlled, dose-ranging, Phase IIb study (UMBRIEL) evaluating the efficacy and safety of Tozorakimab in adult asthma subjects with poorly controlled symptoms despite treatment with medium- to high-dose inhaled corticosteroids has been initiated by AstraZeneca AB, AstraZeneca Global R&D (China) Co., Ltd., and Patheon Manufacturing Services LLC. The clinical trial registration number is CTR20253511, and the initial information disclosure date was September 9, 2025.

The drug formulation has not been disclosed yet. The primary objective of this trial is to evaluate the effect of two dose levels of Tozorakimab compared with placebo on the annual rate of severe asthma exacerbations. Secondary objectives include evaluating the effect of two dose levels of Tozorakimab on the annual rate of severe asthma exacerbations in specific asthma subjects, the time to the first severe asthma exacerbation, the impact on lung function, the influence on asthma symptoms and asthma control, as well as assessing the PK and immunogenicity of Tozorakimab. The safety objective is to evaluate the safety and tolerability of Tozorakimab.

Tozorakimab is a biologic product indicated for adult asthma that is not well controlled with medium to high doses of inhaled corticosteroids. Asthma is a chronic airway inflammatory disease with symptoms such as wheezing, shortness of breath, chest tightness, or coughing, often occurring or worsening at night and in the early morning. Diagnosis relies on symptoms, pulmonary function tests, etc., and treatment requires long-term standardized medication.

The primary endpoint of this trial is the annual rate of severe asthma exacerbations within 52 weeks; secondary endpoints include the annual rate of severe asthma exacerbations within 52 weeks, the estimated time to the first severe asthma exacerbation within 52 weeks, changes in lung function-related parameters from baseline during weeks 20-52, changes in asthma-related scores from baseline at week 26, serum trough concentrations of Tozorakimab and anti-drug antibody-related indicators during the 52-week treatment period, and the safety and tolerability assessment of Tozorakimab at week 62.

Currently, the trial status is ongoing (recruiting), with a target enrollment of 60 participants in China and 540 participants internationally.

Risk Warning: The market involves risks, and investments should be made with caution. This article is automatically published by an AI large model based on a third-party database. Any information appearing in this article (including but not limited to individual stocks, comments, forecasts, charts, indicators, theories, or any form of expression, etc.) is for reference only and does not constitute personal investment advice. Due to issues such as the quality of the third-party database, we are unable to verify or confirm the authenticity and completeness of the data. Therefore, the content of this article may contain inaccuracies, incompleteness, or misleading information, and specific details should be based on company announcements. If you have any questions, please contact biz@staff.sina.com.cn.

Editorial Responsibility: Xiaolang Express