611 for moderate-to-severe COPD in Chinese adults

A Multi-Centered, Randomized, Double-Blinded, Placebo-Controlled Phase III Clinical Trial, to Evaluate the Efficacy and Safety of 611 in Chinese Adults With Moderate to Severe Chronic Obstructive Pulmonary Disease

This will test whether 611 reduces flare-ups and is safe for Chinese adults aged 40–85 with moderate to severe COPD who have had recent exacerbations.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 594 (estimated)
• Ages: 40 Years to 85 Years
• Sex: All
• Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. (Industry-sponsored)
• Locations: 4 sites (Beijing, Beijing Municipality and 3 other locations)
• Trial ID: NCT07039669 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults 40–85 in China with documented moderate-to-severe COPD, a ≥10 pack-year smoking history, and ≥2 moderate or ≥1 severe exacerbation in the past year who are on stable triple inhaled therapy (or LABA+LAMA if ICS is contraindicated) are ideal candidates.

Not a fit: Patients with mild COPD, no recent exacerbations, those outside the 40–85 age range, not on the required background inhaled therapy, or unable to attend Chinese study sites are unlikely to receive benefit from this trial.

Why it matters

Potential benefit: If successful, 611 could reduce COPD exacerbations and improve symptom control and quality of life for patients already on inhaled combination therapy.

How similar studies have performed: There is limited public Phase 3 data specifically for 611, while other pharmacologic approaches to reduce COPD exacerbations have produced mixed but sometimes meaningful results.

Eligibility criteria

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 this trial is running

Beijing, Beijing Municipality and 3 other locations

• China-Japan Friendship Hospital — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• Shenzhen People's Hospital — Shenzhen, Guangdong, China (Recruiting)
• Jiangsu Province Hospital — Nanjing, Jiangsu, China (Recruiting)
• ZheJiang Provincial People's Hospital — Hangzhou, Zhejiang, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Qinghong Zhou, Master

Conditions Pulmonary Disease, Chronic Obstructive