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New treatment option for Pulmonary Disease, Chronic Obstructive (COPD)
Official title Evaluation of 611 in Chinese Adults Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
ClinicalTrials.gov ID: NCT07039669
What this study is testing
What is 611?
611 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for pulmonary disease, chronic obstructive (copd).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The objective of the study was to evaluate the efficacy and safety of 611 in Chinese adults with moderate to severe COPD.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 85
You may be able to join if
- Able to understand and follow the protocol requirements, and give written informed consent prior to participation voluntarily in the study.
- Male or female adults ages 40 to 85 years old when signing the informed consent.
- Current or former smokers with a smoking history of ≥10 pack-years.
- Documented diagnosis of COPD for at least 12 months prior to enrolment
- Moderate-to-severe COPD.
You likely can't join if
- Presence of a known pre-existing, clinically important lung condition other than COPD.
- A current diagnosis of asthma or history of asthma according to the Global Initiative for Asthma (GINA) guidelines or other accepted guidelines.
- Diagnosis of α-1 anti-trypsin deficiency.
- Presence of an active autoimmune disease.
- people who have any malignant tumors within 5 years prior to enrollment.
- Known, pre-existing other concurrent clinically significant medical conditions that are uncontrolled.
See the full eligibility criteria
- Able to understand and follow the protocol requirements, and give written informed consent prior to participation voluntarily in the study.
- Male or female adults ages 40 to 85 years old when signing the informed consent.
- Current or former smokers with a smoking history of ≥10 pack-years.
- Documented diagnosis of COPD for at least 12 months prior to enrolment
- Moderate-to-severe COPD.
- Documented history of ≥ 2 moderate or ≥ 1 severe COPD exacerbations within 12 months prior to enrolment.
- 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.
- Female people of reproductive age (and their male partners) and male people (and their female partners) must use highly effective contraception throughout the study period and for at least 3 months after the last dose...
- Presence of a known pre-existing, clinically important lung condition other than COPD.
- A current diagnosis of asthma or history of asthma according to the Global Initiative for Asthma (GINA) guidelines or other accepted guidelines.
- Diagnosis of α-1 anti-trypsin deficiency.
- Presence of an active autoimmune disease.
- people who have any malignant tumors within 5 years prior to enrollment.
- Known, pre-existing other concurrent clinically significant medical conditions that are uncontrolled.
- Diagnosed active parasitic infection, suspected or high risk of parasitic infection.
- people who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.
- Known with allergic or intolerant to any biological product.
- Any reason which, in the opinion of investigator, would prevent the subject from participating in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Shenzhen, Guangdong, China
- Nanjing, Jiangsu, China
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Shenzhen, Guangdong, China; Nanjing, Jiangsu, China; Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.