Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New COPD drug 611 shows promise in early trial

NCT ID NCT06099652

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

142 people

The number who actually took part.

Started

Dec 2023

Finished

Jun 2025

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

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.

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 are added.

Vår säkerhetsrekommendation!

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.

Contacts and locations

Locations

  • China-Japan Friendship Hospital

    Beijing, Beijing Municipality, 100029, China

  • Shenzhen People's Hospital

    Shenzhen, Guangdong, 518020, China

  • Zhongshan Hospital affiliated to Fudan University

    Shanghai, Shanghai Municipality, 200032, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.