610 for severe asthma in adults

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of 610 in Chinese Adult Subjects With Severe Eosinophilic Asthma

This trial will test whether 610 is safe and helps control severe asthma in Chinese adults.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 480 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06323213 on ClinicalTrials.gov

What this trial studies

This Phase 3 interventional study sponsored by Sunshine Guojian tests 610 versus placebo in adults with severe asthma over a total participation time of about 66 weeks, including 6 weeks screening, 52 weeks treatment, and 8 weeks follow-up. Eligible participants are adults 18 to 75 with a physician diagnosis of asthma for at least one year who require inhaled corticosteroids plus at least one other controller medication. Participants will be assigned to receive either 610 or placebo and monitored for safety and clinical outcomes throughout the treatment period at the study site. The trial is conducted at Shanghai General Hospital and focuses on collecting long-term efficacy and safety data in a Chinese adult population.

Who should consider this trial

Good fit: Chinese adults aged 18–75 with physician-diagnosed severe asthma for at least one year who are taking inhaled corticosteroids plus another controller medication are the intended participants.

Not a fit: Patients with other significant lung diseases, recent severe asthma exacerbation, other eosinophilic diseases, uncontrolled serious medical conditions (including severe cardiovascular disease), or active Hepatitis B, Hepatitis C, or HIV infection are unlikely to qualify or benefit from participation.

Why it matters

Potential benefit: If successful, 610 could become a new treatment option that reduces exacerbations and improves control for adults with severe asthma.

How similar studies have performed: Other targeted biologic therapies for severe asthma have shown benefit in reducing exacerbations and improving control, but the effectiveness of 610 specifically must be confirmed in this Phase 3 trial.

Eligibility criteria

Inclusion Criteria:

1. Able to give written informed consent prior to participation in the study.
2. Male or female adults ages 18 to 75 years old when signing the informed consent.
3. Documented diagnosis of asthma for at least one year prior to screening.
4. History of physician-diagnosed asthma requiring treatment with ICS and at least one other control medication for at least 6 months prior to screening.

Exclusion Criteria:

1. Presence of a known pre-existing, clinically important lung condition other than asthma.
2. Severe asthma exacerbation within 4 weeks prior to randomization.
3. Subjects with any eosinophilic diseases other than asthma.
4. Known, pre-existing severe or clinically significant cardiovascular disease.
5. known, pre-existing other concurrent clinically significant medical conditions that are uncontrolled with standard treatment.
6. Subjects who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.
7. Subjects with allergy/intolerance to a monoclonal antibody.

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai General Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Principal investigator: Min Zhang — Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Study coordinator: Qinghong Zhou, MD

Conditions Asthma