Study of Stapokibart Injection in Adolescent Subjects With Seasonal Allergic Rhinitis (SAR)

Phase 2Not Yet RecruitingNCT07617324

Chengdu Kangnuoxing Biopharma,Inc.15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Seasonal Allergic Rhinitis (SAR)

Interventions

Stapokibart injectionBIOLOGICAL

subcutaneous injection

Eligibility

Sex: ALLMin age: 12 YearsMax age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Beijing Tongren Hospital, CMU

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Safety parameters

Incidence of adverse events

Time frame: From the signing of ICF(Informed Consent Form) until study completion (or early withdrawal),about 0.5 years

Central Contacts

Qian Jia

CONTACT

028-88610620 clinicaltrial@keymedbio.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.