Allergic Asthma
Conditions
Brief summary
This phase IIa trial is meant to evaluate the pharmacokinetics, pharmacodynamics and safety of JYB1904 in patients with allergic asthma.
Interventions
DRUGJYB1904
Participants will receive JYB1904 every 8 weeks for 24 weeks.
DRUGOmalizumab
Participants will receive Omalizumab every 2/4 weeks for 24 weeks.
Sponsors
Jemincare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Able to provide written informed consent voluntarily; * Aged 18-75 years, weight ≥ 40 kg, male or female; * Diagnosed Allergic asthma.
Exclusion criteria
* Prior exposure to anti-IgE therapy within 1 year; * Allergic to anti-IgE biologics; * Current smokers, or quit smoking within 1 year; * Combined with other non-allergic diseases that cause IgE elevation； * History of malignancy, autoimmune diseases, Immune complex mediated diseases, Hypereosinophilic syndrome; * Other conditions unsuitable for the trial judged by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum concentrations of JYB1904 | Baseline through 337 days post-dose | Serum concentrations of JYB1904, assessed by pre-specified methods |
| Serum concentrations of IgE | Baseline through 337 days post-dose | Serum concentrations of IgE, assessed by pre-specified methods |
| Adverse Events(AEs) | Baseline through 337 days post-dose | Incidence and features of AEs assessed by CTCAE v5.0, and related safety parameters analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Times of protocol-defined asthma exacerbations during the 24-week treatment period | Baseline through 168 days post-dose | Times of protocol-defined asthma exacerbations during the 24-week treatment period |
| Change in spirometry measures of forced expiratory volume in one second (FEV1) in 24 weeks | Baseline through 24 weeks post-dose | forced expiratory volume in one second (FEV1) |
| Serum concentrations of anti-drug antibody (ADA) | Baseline through 337 days post-dose | Serum ADA assessed by pre-specified methods, and related immunogenic features analysis |
Countries
China
Contacts
STUDY_CHAIRMin Zhang
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed