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

Sunshine Guojian Pharmaceutical

Status and phase: Enrolling; Phase 3

Conditions: Pulmonary Disease, Chronic Obstructive (COPD)

Treatments: Drug: Placebo; Drug: 611

Study type: Interventional

Funder types: Industry

Identifiers

NCT07039669

SSGJ-611-COPD-III-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 594 estimated patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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594 participants in 2 patient groups, including a placebo group

611

Experimental group

Description:

611 Q2W, subcutaneous (SC) injection

Treatment:

Drug: 611

placebo

Placebo Comparator group

Description:

placebo Q2W, subcutaneous (SC) injection

Treatment:

Drug: Placebo