611 for moderate-to-severe COPD in Chinese 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, randomized, placebo-controlled trial tested the efficacy and safety of 611 over a 52-week treatment period with an additional 8-week follow-up, for a maximum participation duration of 66 weeks including screening. Participants were adults 40–85 years old with documented moderate-to-severe COPD, a ≥10 pack-year smoking history, and a history of ≥2 moderate or ≥1 severe exacerbations in the prior year. Enrolled patients remained on stable background inhaled therapy (ICS+LABA+LAMA) for at least 1 month prior to randomization, with LABA+LAMA allowed if ICS was contraindicated. The trial was conducted at multiple hospital sites in China and compared 611 against placebo for safety and clinical outcomes related to exacerbations and COPD control.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Able to understand and follow the protocol requirements, and give written informed consent prior to participation voluntarily in the study.
2. Male or female adults ages 40 to 85 years old when signing the informed consent.
3. Current or former smokers with a smoking history of ≥10 pack-years.
4. Documented diagnosis of COPD for at least 12 months prior to enrolment
5. Moderate-to-severe COPD.
6. Documented history of ≥ 2 moderate or ≥ 1 severe COPD exacerbations within 12 months prior to enrolment.
7. Background triple therapy (ICS + LABA + LAMA) for 3 months prior to randomization with a stable dose of medication for ≥ 1 month prior to randomization; Double therapy (LABA + LAMA) allowed if ICS is contraindicated.
8. Female subjects of reproductive age (and their male partners) and male subjects (and their female partners) must use highly effective contraception throughout the study period and for at least 3 months after the last dose. The subjects had no plans to pregnancy, donate sperm or donate egg during the whole study period and for at least 3 months after the last dose.

Exclusion Criteria:

1. Presence of a known pre-existing, clinically important lung condition other than COPD.
2. A current diagnosis of asthma or history of asthma according to the Global Initiative for Asthma (GINA) guidelines or other accepted guidelines.
3. Diagnosis of α-1 anti-trypsin deficiency.
4. Presence of an active autoimmune disease.
5. Subjects who have any malignant tumors within 5 years prior to enrollment.
6. Known, pre-existing other concurrent clinically significant medical conditions that are uncontrolled.
7. Diagnosed active parasitic infection, suspected or high risk of parasitic infection.
8. Subjects who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.
9. Known with allergic or intolerant to any biological product.
10. Any reason which, in the opinion of investigator, would prevent the subject from participating in the study.

Where it's running

• Shenzhen People's Hospital
  Shenzhen, Guangdong, China Recruiting
• Jiangsu Province Hospital
  Nanjing, Jiangsu, China Recruiting
• China-Japan Friendship Hospital
  Beijing, Beijing Municipality, China Not yet recruiting
• ZheJiang Provincial People's Hospital
  Hangzhou, Zhejiang, China Not yet recruiting

Study contacts

• Study coordinator: Qinghong Zhou, Master
• 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.