New drug 611 aims to cut COPD attacks in chinese patients
NCT ID NCT07039669
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This Phase 3 trial tests whether the experimental drug 611 can reduce moderate to severe COPD flare-ups in Chinese adults aged 40-85 with moderate to severe COPD. About 594 participants will receive either 611 or a placebo injection every two weeks. The study measures how often flare-ups occur and changes in lung function over 24 weeks.
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 subcutaneous injection)
- What this could lead to
- If successful, 611 could become a new treatment option to reduce the number of COPD flare-ups and help people breathe better.
- What could go wrong
- This is a Phase 3 trial, but it's still experimental. It may not work better than placebo, and side effects are possible. Results may only apply to Chinese adults.
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
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
About 594 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jul 2025
- Expected to finish
-
Nov 2028
An estimate. End dates often move.
- Lead sponsor
-
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
-
40 to 85 years
- Sex
-
Anyone
- Healthy volunteers
-
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. 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Pulmonary disease, chronic obstructive (COPD) are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
4 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
China-Japan Friendship Hospital
NOT_YET_RECRUITINGBeijing, Beijing Municipality, 100029, China
-
Jiangsu Province Hospital
RECRUITINGNanjing, Jiangsu, 212028, China
-
Shenzhen People's Hospital
RECRUITINGShenzhen, Guangdong, 518020, China
-
ZheJiang Provincial People's Hospital
NOT_YET_RECRUITINGHangzhou, Zhejiang, 310014, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Smart sensors aim to predict dangerous COPD attacks before they happen
- Smart breathing machines at home could cut hospital visits for COPD patients
- Can 'Box Breathing' help COPD patients catch their breath?
- New oxygen gadget boosts exercise in COPD patients
- Real-World COPD study tracks benefits of switching to triple inhaler
- Swedish Mega-Study scans 1,400 for clues to heart, lung, and liver disease