SHR-1905 for adults with severe uncontrolled asthma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 interventional trial compares SHR-1905 injections with placebo in adults who remain uncontrolled on medium-to-high dose inhaled corticosteroids plus another controller. Eligible participants must have physician-diagnosed asthma for at least 12 months, pre-bronchodilator FEV1 below 80% predicted, an ACQ-6 score ≥ 1.5, and a recent history of at least two exacerbations. The study will monitor efficacy and safety over the treatment period using standard asthma outcomes such as exacerbation rates, lung function, and symptom control. Safety monitoring will include adverse event reporting and clinical assessments at the study site.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥ 18.
2. Documented physician-diagnosed asthma for at least 12 months.
3. Participants who have received asthma controller medication with medium or high dose ICS for at least 6 months.
4. Documented treatment with a total daily dose of either medium or high dose ICS (Refer to Guidelines for the prevention and management of bronchial asthma (2024 edition)) for at least 3 months.
5. At least one additional maintenance asthma controller medication is required according to standard practice of care and must be documented for at least 3 months.
6. Pre-BD FEV1 \< 80% predicted normal.
7. Objective evidence of asthma as documented.
8. Documented history of at least 2 asthma exacerbation events within 12 months, and at least one of the exacerbations should occur during the treatment of medium-to-high dose ICS.
9. ACQ-6 score ≥ 1.5 at screening and on day of baseline.
10. ePRO adherence ≥ 70% in the 7 days prior to randomization.

Exclusion Criteria:

1. Clinically significant pulmonary disease other than asthma.
2. History of cancer.
3. History of a clinically significant infection.
4. Current smokers or participants with smoking history ≥ 10 pack-yrs.
5. History of chronic alcohol or drug abuse within 12 months.
6. Hepatitis B, C or HIV.
7. Pregnant or breastfeeding.
8. History of anaphylaxis following any biologic therapy.
9. participant randomized in the current study or previous SHR-1905 studies.

Where it's running

• The First Affiliated Hospital of Guangzhou Medical University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Zhou Li
• Email: zhou.li.zl69@hengrui.com
• Phone: +86-020-62726806

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.