NCT06099652CompletedPhase 2
A Multi-Centered, Randomized, Double-Blinded, Placebo-Controlled Phase II Clinical Trial, to Evaluate the Efficacy and Safety of 611 in Chinese Adults With Moderate to Severe Chronic Obstructive Pulmonary Disease.
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.3 sites in 1 country142 target enrollmentStarted: December 8, 2023Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 142
- Locations
- 3
- Primary Endpoint
- Change from baseline in pre-bronchodilator FEV1 at Week 16
Study Overview
Brief Summary
The primary 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 28 weeks per participants, including a screening period of up to 4 weeks, a 16-week randomized treatment period, and a 8-week follow-up period.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subject must be able to understand and comply with the requirements of the study. and must participate voluntarily and sign the written informed consent.
- •Male or female adults ages 40 to 85 years old when signing the informed consent.
- •BMI≥16 kg/m
- •Documented diagnosis of COPD for at least one year prior to enrolment.
- •Post-bronchodilator FEV1/FVC < 0.70 and post-bronchodilator FEV1 % predicted >30% and ≤70%.
- •Current or former smokers with a smoking history of ≥10 pack-years or environmental exposure to biofuel fumes ≥10 years
- •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.
- •Patients with blood eosinophils ≥200 cells/microliter at screening.
- •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
- •Significant pulmonary disease other than COPD (e.g., active tuberculosis，lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung disease, etc)
- •Diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts.
- •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.
- •Cor pulmonale, evidence of right cardiac failure
- •Any history of vernal keratoconjunctivitis (VKC) and atopic keratoconjunctivitis (AKC).
- •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.
- •Patients who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.
- •Hypercapnia requiring Bi-level ventilation.
- •AECOPD as defined in inclusion criteria within 4 weeks prior to screening or randomization.
- •History of, or planned pneumonectomy or lung volume reduction surgery.
- •Treatment with oxygen of more than 12 hours per day.
- •Known with allergic or intolerant to mometasone furoate spray or 611/placebo.
- •Any reason which, in the opinion of investigator, would prevent the subject from participating in the study.
Arms & Interventions
group A
Experimental
611 300 mg Q2W, subcutaneous (SC) injection
Intervention: 611 300 mg Q2W (Drug)
group B
Experimental
611 450 mg Q2W, subcutaneous (SC) injection
Intervention: 611 450 mg Q2W (Drug)
placebo group
Placebo Comparator
placebo Q2W, subcutaneous (SC) injection
Intervention: Matching placebo (Drug)
Outcomes
Primary Outcomes
Change from baseline in pre-bronchodilator FEV1 at Week 16
Time Frame: up to Week 16
FEV1 is the Forced expiratory volume in one second at study site
Secondary Outcomes
- Annualized rate of moderate to severe COPD exacerbations in participants(up to Week 16)
- Change from baseline in Chronic Obstructive Pulmonary Disease assessment tool (CAT) score(up to Week 16)
- Percentage of participants with a decrease in SGRQ total score of ≥ 4 points from baseline to Week 16(up to Week 16)
- Adverse events (AEs), measurement of vital signs，physical examination，electrocardiogram and laboratory tests at each visit.(Up to 24 Weeks)
- Change in serum concentrations of PD variables(Up to 24 Weeks)
- Time to first Moderate or severe COPD exacerbation(up to Week 16)
- 611 Concentration in Serum(Up to 24 Weeks)
- Change from baseline in St. George's Respiratory Questionnaire (SGRQ) total score(up to Week 16)
- Percentage of Participants with Anti-drug Antibodies and Neutralizing Antibodies(Up to 24 Weeks)
Investigators
Study Sites (3)
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