Clinical trial NCT06680947: A Phase IIb Study of 610 in Participants With Severe Eosinophilic Asthma
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase IIb, Effcacy and Safety Study of Recombinant Anti-IL-5 Humanized Monoclonal Antibody Therapy in Adult Subjects With Severe Asthma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Asthma
Lead sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-11-08
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the effcacy and safety of 610 as an adjunctive therapy in adult subjects with severe eosinophilic asthma.

Detailed description: This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the effcacy and safety of 610 in adults with severe eosinophilic asthma. Subjects divided into 3 groups: A group,B group and placebo group. The study is divided into screening period of 4 weeks, treatment period of 16 weeks, prolonged treatment period of 20 weeks and follow-up period of 8 weeks.

Eligibility 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. Female and male aged 18 to 75 years.
* 3. Diagnosed with asthma for ≥12 months that meet GINA.
* 4. History of physician-diagnosed asthma requiring treatment with ICS and at least one other control medication for at least 6 months prior to screening.
* 5. Documented history of ≥ 1 moderate exacerbations within 12 months prior to screening.
* 6. Asthma Control Questionnaire question version (ACQ) score ≥1.5 at the screening visit and the randomization visit.

Exclusion Criteria:

* 1. Presence of a known pre-existing, clinically important lung condition other than Asthma.
* 2. Severe asthma exacerbation within 4 weeks prior to randomization.
* 3. Subjects with any eosinophilic diseases other than asthma.
* 4. Known, pre-existing severe or clinically significant cardiovascular disease.
* 5. known, pre-existing other concurrent clinically significant medical conditions that are uncontrolled with standard treatment.
* 6. Subjects who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.
* 7. Subjects with allergy/intolerance to a monoclonal antibody.

Primary outcomes:
measure: Change from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1) at week 36
timeFrame: Baseline (Day 1) and at week 36
Secondary outcomes:
measure: Changes from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1) at week 16
timeFrame: Baseline (Day 1) and at week 16
measure: Percentage change from baseline in pre-bronchodilator FEV1 at weeks 4, 8,12, 16,20,28,36
timeFrame: Baseline (Day 1) and at week 4,8,12,16,20,28,36
measure: Number of asthma exacerbation through study week 36
timeFrame: From baseline (Day 1) to week 36
measure: Number of asthma exacerbations requiring hospitalization or emergency room visits
timeFrame: From baseline (Day 1) to week 36
measure: Change from baseline in ACQ score.
timeFrame: From baseline (Day 1) to week 36
measure: Change from baseline in ST. GEORGE'S Respiratory Questionnaire(SGRQ)
timeFrame: From baseline (Day 1) to week 36
measure: Assessment of adverse events (AEs)
timeFrame: Up to week 44
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Min Zhang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: