Clinical trial NCT05584306: A Dose Ranging Placebo-controlled Double-blind Study to Evaluate the Safety, Pharmacokinetics and Efficacy of 610 in Participants With Severe Eosinophilic Asthma
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase Ib Study to Determine the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Recombinant Anti-IL-5 Humanized Monoclonal Antibody Therapy in Adult Subjects With Severe Eosinophilic Asthma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Asthma
Keywords: Asthma
Eosinophilic asthma
Exacerbations
610
Placebo
Lead sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-10-18
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the safety, tolerability, pharmacokinetics and preliminary efficacy 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 safety, tolerability, pharmacokinetics and preliminary efficacy of 610 in adults with severe eosinophilic asthma. Plan to recruit 24 subjects, and the subjects divided into 3 groups: 610 30mg group，100mg group, 610 300mg group，8 subjects in each dose group, of which 6 received the trial drug and 2 received placebo. The study is divided into screening period of 2 weeks, treatment period of 32 weeks and follow-up period of 12 weeks.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with asthma for ≥12 months
* Within 3 months before screening, treatment with medium to high dose inhaled corticosteroid（ICS，inhaled fluticasone at a dosage of at least 500 μg, or equivalent, daily.）and at least one other additional controller medication, such as long-acting β₂ receptor agonist (LABA), leukotriene receptor antagonist (LTRA), theophylline, long-acting Anticholinergic drugs (LAMA), etc. Those medicine must be stable for ≥ 28 days prior to screening and baseline and must continue without dosage changes throughout the study
* In the past 12 months prior to screening， at least one time asthma exacerbations history
* Pre-bronchodilator FEV1 \<80% predicted value
* Asthma-related blood eosinophils ≥ 150 cells/μL within 3 months before administration

Exclusion Criteria:

* With clinically important lung diseases other than asthma that may affect safety or efficacy and evaluated by investigator. This includes lung infection, chronic obstructive pulmonary disease, bronchiectasis, hypersensitivity pneumonitis, pulmonary fibrosis, Allergic bronchopulmonary aspergillosis, etc.
* With other conditions that could lead to elevated eosinophils such as hypereosinophilic syndromes, eosinophilic granulomatosis with polyangiitis (EGPA), or eosinophilic esophagitis
* In past 12 months prior to screening，patients has done bronchial thermoplasty or radiotherapy or plan to do it during of the trial
* with severe cardiac disease or uncontrolled or severe cardiac arrhythmia
* poorly controlled systemic disease
* Active infection 7 day before screening
* Parasitic infection within 6 months before screening
* At screening, HBsAg or HCV Ab or HIV Ab or TP Ab positive; HBsAg or HCV Ab positive need to be further tested of HBV DNA titer detection or HCV RNA detection (More than normal value range needs to be excluded)
* Subjects who have received any monoclonal antibody treatment of anti IL-4Ror anti-IL-5/5R
* Vaccination history with live vaccines (including live attenuated vaccines) within 4 weeks before screening, or plan to receive during of the trial
* Participated in any interventional clinical trial and received intervention within 3 months before screening

Primary outcomes:
measure: Adverse events(AEs)
timeFrame: From Day 0 to Day 308
Secondary outcomes:
measure: Pharmacokinetics-Tmax
timeFrame: From Day 0 to Day 308
measure: Pharmacokinetics-AUC0-last
timeFrame: From Day 0 to Day 308
measure: Pharmacokinetics-AUC0-inf
timeFrame: From Day 0 to Day 308
measure: Pharmacokinetics-Cmax
timeFrame: From Day 0 to Day 308
measure: Pharmacokinetics-CL/F
timeFrame: From Day 0 to Day 308
measure: Pharmacokinetics-Vz/F
timeFrame: From Day 0 to Day 308
measure: Pharmacokinetics-t1/2
timeFrame: From Day 0 to Day 308
measure: Pharmacodynamics-Eosinophils
timeFrame: From Day 0 to Day 308
measure: Anti-drug-antibody
timeFrame: From Day 0 to Day 308
measure: Number of asthma exacerbation
timeFrame: From Day 0 to Day 308
measure: Changes from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1)
timeFrame: From Day 0 to Day 308
measure: Percentage change from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1)
timeFrame: From Day 0 to Day 308
measure: Time to first asthma exacerbation event
timeFrame: From Day 0 to Day 308
measure: Number of asthma exacerbations requiring hospitalization (including intubation and ICU admission) or emergency room visits (not conversion to hospitalization)
timeFrame: From Day 0 to Day 308
measure: Number of asthma exacerbations requiring hospitalization (including intubation and ICU admission)
timeFrame: From Day 0 to Day 308
measure: Change from baseline in Asthma Control Questionnaire score
timeFrame: From Day 0 to Day 308
measure: Change From Baseline in the St. George's Respiratory Questionnaire Total Score
timeFrame: From Day 0 to Day 308
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai General Hospital
state: Shanghai
Study officials:
affiliation: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
name: Qinghong Zhou, MD
role: STUDY_DIRECTOR
affiliation: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Xin Zhou, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Min Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References: