A Dose Ranging Placebo-controlled Double-blind Study to Evaluate the Safety, Pharmacokinetics and Efficacy of 610 in Participants With Severe Eosinophilic Asthma
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
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 asthma
Started Dec 2021
Longer than P75 for phase_1 asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 6, 2021
CompletedFirst Submitted
Initial submission to the registry
October 9, 2022
CompletedFirst Posted
Study publicly available on registry
October 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2023
CompletedOctober 18, 2022
October 1, 2022
1.7 years
October 9, 2022
October 17, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adverse events(AEs)
The incidence and severity of AEs, including SAEs, as well as clinical symptoms, and any abnormalities of vital signs, physical examinations#electrocardiogram#laboratory tests and, etc.
From Day 0 to Day 308
Secondary Outcomes (17)
Pharmacokinetics-Tmax
From Day 0 to Day 308
Pharmacokinetics-AUC0-last
From Day 0 to Day 308
Pharmacokinetics-AUC0-inf
From Day 0 to Day 308
Pharmacokinetics-Cmax
From Day 0 to Day 308
Pharmacokinetics-CL/F
From Day 0 to Day 308
- +12 more secondary outcomes
Study Arms (6)
610 30mg group
EXPERIMENTAL610 30 mg administered subcutaneously every 4 weeks
610 100mg group
EXPERIMENTAL610 100 mg administered subcutaneously every 4 weeks
610 300mg group
EXPERIMENTAL610 300mg administered subcutaneously every 4 weeks
Placebo 30mg group
PLACEBO COMPARATORplacebo subcutaneous (SC) Q4W，8 times
Placebo 100mg group
PLACEBO COMPARATORplacebo subcutaneous (SC) Q4W，8 times
Placebo 300mg group
PLACEBO COMPARATORplacebo subcutaneous (SC) Q4W，8 times
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Qinghong Zhou, MD
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
- PRINCIPAL INVESTIGATOR
Xin Zhou, MD
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- PRINCIPAL INVESTIGATOR
Min Zhang, MD
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2022
First Posted
October 18, 2022
Study Start
December 6, 2021
Primary Completion
September 1, 2023
Study Completion
September 1, 2023
Last Updated
October 18, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share