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Not yet recruiting NCT07617324

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

Phase II Interventional Seasonal Allergic Rhinitis (SAR)

For patients and families

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Stapokibart injection.
Who it may be relevant to
Registry conditions: Seasonal Allergic Rhinitis (SAR). Basic parameters: 12 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Multicenter, Single-arm, Open-label Study to Evaluate the Safety and Pharmacokinetics of Stapokibart Injection in Adolescent Patients With SAR Under Background Therapy

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.

Interventions

  • Biological Stapokibart injection
    subcutaneous injection

Primary outcome measures

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

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Beijing Tongren Hospital, CMU — Beijing

Identifiers

NCT: NCT07617324 · CM310-107110

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗