Seasonal Allergic Rhinitis (SAR)
Conditions
Brief summary
This study is a multicenter, single-arm, open-label, phase II study to evaluate the safety, pharmacokinetics, and immunogenicity of Stapokibart injection in Adolescent Patients with SAR.
Interventions
BIOLOGICALStapokibart injection
subcutaneous injection
Sponsors
Chengdu Kangnuoxing Biopharma,Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Voluntarily sign the Informed Consent Form. * Age ≥ 12 years old and \<18 years old, weight ≥ 40 kg. * With a diagnosis of SAR, with or without allergic conjunctivitis, and the SAR duration was ≥ 2 years.
Exclusion criteria
* Not enough washing-out period for previous therapies. * With other poorly controlled serious diseases or chronic conditions. * With any conditions that are not suitable for participation in this study by investigators.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety parameters | From the signing of ICF(Informed Consent Form) until study completion (or early withdrawal),about 0.5 years | Incidence of adverse events |
Countries
China
Contacts
CONTACTQian Jia
STUDY_CHAIRLuo Zhang
Beijing Tongren Hospital, CMU
Outcome results
None listed