610 for severe asthma in adults

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 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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: zhouqinghong@3sbio.com
• Phone: +86 18911301578

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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.