Clinical trial NCT06099652: Evaluation of 611 in Chinese Adults With Moderate to Severe Chronic Obstructive Pulmonary Disease
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-10-25
Enrollment: 150
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Subject must be able to understand and comply with the requirements of the study. and must participate voluntarily and sign the written informed consent.
2. Male or female adults ages 40 to 85 years old when signing the informed consent.
3. BMI≥16 kg/m2.
4. Documented diagnosis of COPD for at least one year prior to enrolment.
5. Post-bronchodilator FEV1/FVC \< 0.70 and post-bronchodilator FEV1 % predicted \>30% and ≤70%.
6. Current or former smokers with a smoking history of ≥10 pack-years or environmental exposure to biofuel fumes ≥10 years
7. Documented history of ≥ 2 moderate or ≥ 1 severe COPD exacerbations within 12 months prior to enrolment.
8. 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.
9. Patients with blood eosinophils ≥200 cells/microliter at screening.
10. 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. Significant pulmonary disease other than COPD (e.g., active tuberculosis，lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung disease, etc)
2. Diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts.
3. A current diagnosis of asthma or history of asthma according to the Global Initiative for Asthma (GINA) guidelines or other accepted guidelines.
4. Diagnosis of α-1 anti-trypsin deficiency.
5. Cor pulmonale, evidence of right cardiac failure
6. Any history of vernal keratoconjunctivitis (VKC) and atopic keratoconjunctivitis (AKC).
7. 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.
8. Patients who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.
9. Hypercapnia requiring Bi-level ventilation.
10. AECOPD as defined in inclusion criteria within 4 weeks prior to screening or randomization.
11. History of, or planned pneumonectomy or lung volume reduction surgery.
12. Treatment with oxygen of more than 12 hours per day.
13. Known with allergic or intolerant to mometasone furoate spray or 611/placebo.
14. Any reason which, in the opinion of investigator, would prevent the subject from participating in the study.

Primary outcomes:
measure: Change from baseline in pre-bronchodilator FEV1 at Week 16
timeFrame: up to Week 16
Secondary outcomes:
measure: Change from baseline in Chronic Obstructive Pulmonary Disease assessment tool (CAT) score
timeFrame: up to Week 16
measure: Change from baseline in St. George's Respiratory Questionnaire (SGRQ) total score
timeFrame: up to Week 16
measure: Percentage of participants with a decrease in SGRQ total score of ≥ 4 points from baseline to Week 16
timeFrame: up to Week 16
measure: Annualized rate of moderate to severe COPD exacerbations in participants
timeFrame: up to Week 16
measure: Time to first Moderate or severe COPD exacerbation
timeFrame: up to Week 16
measure: Adverse events (AEs), measurement of vital signs，physical examination，electrocardiogram and laboratory tests at each visit.
timeFrame: Up to 24 Weeks
measure: 611 Concentration in Serum
timeFrame: Up to 24 Weeks
measure: Percentage of Participants with Anti-drug Antibodies and Neutralizing Antibodies
timeFrame: Up to 24 Weeks
measure: Change in serum concentrations of PD variables
timeFrame: Up to 24 Weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guangdong
city: Shanghai
country: China
facility: Zhongshan Hospital affiliated to Fudan University
state: Shanghai
Study officials:
References: