Recruiting NCT07039669
Evaluation of 611 in Chinese Adults Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 611, Placebo.
- Who it may be relevant to
- Registry conditions: Pulmonary Disease, Chronic Obstructive (COPD). Basic parameters: 40 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
The objective of the study was to evaluate the efficacy and safety of 611 in Chinese adults with moderate to severe COPD.
Detailed description
The maximum study duration was 66 weeks per participants, including a screening period of up to 6 weeks, a 52-week randomized treatment period, and a 8-week follow-up period.
Interventions
- Drug 611
611 subcutaneous (SC) injection - Drug Placebo
placebo Q2W, subcutaneous (SC) injection
Primary outcome measures
- Annualized rate of moderate or severe COPD Exacerbations [Time frame: Baseline to Week 52]
Secondary outcome measures (12)
- Change from baseline in pre-bronchodilator FEV1 at Week 24 [Time frame: Baseline, Week 24]
- Time to first Moderate or severe COPD exacerbation [Time frame: Baseline to Week 52]
- Annualized rate of severe COPD Exacerbations [Time frame: Baseline to Week 52]
- Change from baseline in pre-bronchodilator FEV1 [Time frame: Baseline to Week 52]
- Change from baseline in SGRQ scores [Time frame: Baseline to Week 52]
- Percentage of participants with a decrease in SGRQ total score of ≥ 4 points from baseline [Time frame: Baseline to Week 16]
- Change from baseline in post-bronchodilator FEV1 [Time frame: Baseline to Week 52]
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) [Time frame: Up to 60 Weeks]
- 611 Concentration in Serum [Time frame: Baseline to Week 60]
- Percentage of Participants With Anti-drug Antibodies and Neutralizing Antibodies [Time frame: Baseline to Week 60]
- Change in serum concentrations of Pulmonary and activation-regulated chemokine (PARC) [Time frame: Baseline to Week 60]
- Change in serum concentrations of IgE [Time frame: Baseline to Week 60]
Eligibility criteria
Inclusion 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 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
- 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.
- Subjects 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.
- Subjects 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 4 centers
- China-Japan Friendship Hospital — Beijing
- Shenzhen People's Hospital — Shenzhen
- Jiangsu Province Hospital — Nanjing
- ZheJiang Provincial People's Hospital — Hangzhou
Identifiers
NCT: NCT07039669 · SSGJ-611-COPD-III-01