SHR-1905 for adults with severe uncontrolled asthma

A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel Group Phase Ⅲ Study to Evaluate the Efficacy and Safety of SHR-1905 in Subjects With Severe Uncontrolled Asthma

This Phase 3 trial will test whether SHR-1905 injections help adults with severe uncontrolled asthma have fewer flare-ups and better symptom control.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 408 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd (Industry-sponsored)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT07098403 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18 years) with physician-diagnosed asthma for ≥12 months who remain uncontrolled despite medium-to-high dose inhaled corticosteroids plus at least one additional controller, with pre-bronchodilator FEV1 <80%, ACQ-6 ≥1.5, and at least two exacerbations in the prior year are the intended participants.

Not a fit: People with well-controlled asthma, those on low-dose ICS only, those with other significant respiratory diseases, or those unable to meet adherence and site-visit requirements are unlikely to match the trial criteria or receive benefit.

Why it matters

Potential benefit: If successful, SHR-1905 could reduce exacerbations and improve lung function and daily symptom control for adults with severe uncontrolled asthma.

How similar studies have performed: Other biologic therapies for severe asthma have shown reduced exacerbations and improved control in Phase 3 trials, so the general biologic approach has precedent although SHR-1905 itself is a novel agent under testing.

Eligibility criteria

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 this trial is running

Guangzhou, Guangdong

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

Study contacts

• Study coordinator: Zhou Li

Conditions Asthma