Thinking of joining a study?

Register your interest

Become a volunteer?

NCT07039669 | RECRUITING | Pulmonary Disease, Chronic Obstructive (COPD)

Evaluation of 611 in Chinese Adults Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
Sponsor:

sunshine GU Okey pharmaceutical (Shanghai) co., Ltd.

Brief Summary:

The objective of the study was to evaluate the efficacy and safety of 611 in Chinese adults with moderate to severe COPD.

Condition or disease

Pulmonary Disease, Chronic Obstructive (COPD)

Intervention/treatment

611

Placebo

Phase

PHASE3

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 594 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2025-07-16
Estimated Primary Completion Date : 2028-09
Estimated Study Completion Date : 2028-11

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 40 Years to 85 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
Evaluation of 611 in Chinese Adults Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

Location Details

NCT07039669

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

NOT YET RECRUITING

China, Beijing Municipality

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China, 100029

RECRUITING

China, Guangdong

Shenzhen People's Hospital

Shenzhen, Guangdong, China, 518020

RECRUITING

China, Jiangsu

Jiangsu Province Hospital

Nanjing, Jiangsu, China, 212028

NOT YET RECRUITING

China, Zhejiang

ZheJiang Provincial People's Hospital

Hangzhou, Zhejiang, China, 310014