New COPD drug 611 shows promise in early trial
NCT ID NCT06099652
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This Phase 2 trial tested an experimental drug called 611 in 142 Chinese adults with moderate-to-severe COPD. Participants received either 611 or a placebo as a shot under the skin every two weeks. The study measured changes in lung function and symptom scores over 16 weeks to see if 611 could help control the disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 611 (an experimental drug given as a shot under the skin)
- What this could lead to
- If it works, 611 could become a new treatment option to help control COPD and improve breathing and daily life.
- What could go wrong
- This is an early Phase 2 trial with only 142 people, so results may not apply to everyone. The drug may not work better than placebo, and side effects are still being studied.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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142 people
The number who actually took part.
- Started
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Dec 2023
- Finished
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Jun 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Subject must be able to understand and comply with the requirements of the study. and must participate voluntarily and sign the written informed consent. 2. Male or female adults ages 40 to 85 years old when signing the informed consent. 3. BMI≥16 kg/m2. 4. Documented diagnosis of COPD for at least one year prior to enrolment. 5. Post-bronchodilator FEV1/FVC \< 0.70 and post-bronchodilator FEV1 % predicted \>30% and ≤70%. 6. Current or former smokers with a smoking history of ≥10 pack-years or environmental exposure to biofuel fumes ≥10 years 7. Documented history of ≥ 2 moderate or ≥ 1 severe COPD exacerbations within 12 months prior to enrolment. 8. 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. 9. Patients with blood eosinophils ≥200 cells/microliter at screening. 10. 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. Significant pulmonary disease other than COPD (e.g., active tuberculosis,lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung disease, etc) 2. Diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts. 3. A current diagnosis of asthma or history of asthma according to the Global Initiative for Asthma (GINA) guidelines or other accepted guidelines. 4. Diagnosis of α-1 anti-trypsin deficiency. 5. Cor pulmonale, evidence of right cardiac failure 6. Any history of vernal keratoconjunctivitis (VKC) and atopic keratoconjunctivitis (AKC). 7. A participant with a history of clinically significant renal, hepatic, cardiovascular, metabolic, neurologic, hematologic, ophthalmologic, respiratory, gastrointestinal, cerebrovascular or other significant medical illness or disorder which, in the judgment of the Investigator, could interfere with the study or require treatment that might interfere with the study. 8. Patients who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening. 9. Hypercapnia requiring Bi-level ventilation. 10. AECOPD as defined in inclusion criteria within 4 weeks prior to screening or randomization. 11. History of, or planned pneumonectomy or lung volume reduction surgery. 12. Treatment with oxygen of more than 12 hours per day. 13. Known with allergic or intolerant to mometasone furoate spray or 611/placebo. 14. Any reason which, in the opinion of investigator, would prevent the subject from participating in the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029, China
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Shenzhen People's Hospital
Shenzhen, Guangdong, 518020, China
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Zhongshan Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality, 200032, China
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